L1: DRAFT INTERNATIONAL DIHIAS 08 - 00600 Date Reference...

L1: DRAFT INTERNATIONAL HALAL INTEGRITY ALLIANCE STANDARD

WARNING: This document is a Draft International Halal Integrity Alliance Standard (IHI

Alliance). It is distributed for review and comment. It is subject to change without notice and may not be referred to as an International Halal Integrity Alliance Standard.

IHI/TC 8 WG8-1,WG8-2,WG8-3 Circulated to TC members and to

organisations in liaison for:

Title Information

HALAL COSMETICS AND PERSONAL CARE Discussion at [venue/date of meeting]

Secretariat Comments by

[date]

Approval for registration as DIHIAS in accordance with TC directives, by

[date]

HALAL COSMETICS AND PERSONAL CARE

Copyright Notice

This document is a committee draft and its copyright is protected by IHI Alliance. While the reproduction of this document in any form for use of participants in the IHI Alliance Halal standard development process is permitted without prior written permission from IHI Alliance, neither this document nor any extract from it may be reproduced, stored or transmitted in any form for any other purpose without prior written permission from IHI Alliance. © IHI Alliance 2010 - All rights reserved

DIHIAS 08 - 00600 Date Reference number

21-06-2010 IHIAS/TC8 N1.5 Supercedes document

N1.4

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32

© IHI Alliance 2010 – All rights reserved TC 8 Halal Cosmetics & Personal Care

CONTENTS

Foreword .................................................................................................................... 5 Introduction ………..................................................................................................... 6 1.0 Scope.............................................................................................................................. 7 2.0 Normative references..................................................................................................... 7 3.0 Definitions...................................................................................................................... 7 3.1 Shariah........................................................................................................................... 8 3.2 Halal............................................................................................................................... 8 3.3 Non-Halal / Haram ....................................................................................................... 8 3.4 Shubhah ........................................................................................................................ 9 3.5 3.6 3.7

Najs ............................................................................................................................. The Organisation ............................................................................................................ Ritual Cleansing ..............................................................................................................

9

9

10 3.8 Batch ............................................................................................................................. 10 3.9 Bulk Product................................................................................................................... 10 3.10 Calibration ..................................................................................................................... 10 3.11 Cosmetics and personal care ......................................................................................... 10 3.12 Halal cosmetics and personal care .................................................................................. 10 3.13 Documentation ............................................................................................................. 11 3.14 Product ......................................................................................................................... 11 3.15 Raw materials ............................................................................................................... 11 3.16 Processing aids ............................................................................................................. 11 4.0 Requirements ................................................................................................................ 11 4.1 Organisation, Qualification and Responsibilities ............................................................. 12 4.2 Training .......................................................................................................................... 14 4.3 Premises......................................................................................................................... 14 4.4 Equipment …….…............................................................................................................ 16

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


5.0 Cosmetics and personal care production........................................................................ 19 5.1 Raw Materials ................................................................................................................ 19 5.2 Starting materials .......................................................................................................... 20 5.3 Verification Materials .................................................................................................... 20 5.4 Rejected Materials ......................................................................................................... 21 5.5 Batch Numbering System ............................................................................................... 21 5.6 Weighing and Measurement .......................................................................................... 21 5.7 Procedure and Processing .............................................................................................. 21 5.8 Dry Products .................................................................................................................. 22 5.9 Wet Products ................................................................................................................. 22 5.10 Labelling and Packaging ................................................................................................. 23 5.11 Finished Product: Quarantine and Delivery to Finished Stock ……………………………………… 24 6.0 Quality Control................................................................................................................ 24 6.1 Quality control system.................................................................................................... 24 6.2 Reprocessing .................................................................................................................. 24 6.3 Returned Products ......................................................................................................... 24 7.0 Documentation ……………................................................................................................. 25 7.1 Document system .......................................................................................................... 25 7.2 Specifications ................................................................................................................. 25 7.3 Documents for Production ............................................................................................. 26 8.0 Internal Audits ……......................................................................................................... 27 9.0 Storage .......................................................................................................................... 28 9.1 Storage areas ................................................................................................................. 28 9.2 Stock Handling and Control ............................................................................................ 28 10.0 Contract Manufacturing and Analysis ............................................................................. 29 11.0 Complaints ..................................................................................................................... 29 12.0 Product Recalls .............................................................................................................. 30 13.0 Legal Requirements ....................................................................................................... 31

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


14. Marking ......................................................................................................................... 31 15. Halal Cosmetics and Personal Care Certification ............................................................. 32 15.1 Organisation …............................................................................................................... 32 15.2 Compliance .................................................................................................................... 32 15.3 Certification mark .......................................................................................................... 32

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


FOREWORD

International Halal Integrity Alliance (IHI Alliance) is a non-government, non-profit

organisation, set up following a resolution passed by international delegates from over 30

countries, consisting of cross section of stakeholders across the whole industry supply chain,

at the World Halal Forum 2006. IHI Alliance was mandated to spearhead the development

of the International Halal Standard. This mandate was reinforced by a resolution passed at

the Organisation of Islamic Conference (OIC) in March 2008 through our partnership with

the Islamic Chamber of Commerce and Industry (ICCI) to be the one voice representing

values regards to Halal and quality control.

The IHI Alliance Standards are developed in accordance to guidelines adapted from ISO/IEC

(the International Organization for Standardization / the International Electrotechnical

Commission), Guidelines for International Standards Development, while adhering to WTO-

TBT (World Trade Organization-Technical Barriers to Trade) Code of Good Practice for

Standards Development.

The work of preparing International Halal standards is carried out through IHI Alliance

technical committees. Each member body interested in a subject that a technical committee

has been established has the right to be represented on that committee, international

organisation, governmental and non-governmental, industry players, and Shariah experts, in

liaison with IHI Alliance, also take part in the development.

The main task of technical committees is to prepare international Halal standards. Draft IHI

Alliance Standards prepared by technical committees will be circulated among stakeholders

for comment. Publication as a final International Halal Standards requires approval by IHI

Alliance Shariah Board and Standards Management Board.

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


INTRODUCTION 1 2 Cosmetics are substances used to enhance or protect the appearance of the human body. It 3 is extremely important that Halal cosmetics and personal care manufacturing is segregated 4 from non Halal products, to avoid cross contamination and mistakes and to ensure that the 5 production is consistent with the expectations of the stakeholders. 6 7 The concept of Halal cosmetics and personal care processing is incomplete without coupling 8 it with best practice in cosmetics production, that is, traceability is in place, ensures an 9 unbroken cold chain, protection of shelf life by short supply chain lead times and high 10 hygiene and sanitation standard. 11 12 This document is a comprehensive standard for Halal Cosmetics and Personal Care 13 processing worldwide, incorporating the good manufacturing practice (GMP), Islamic 14 schools of thought (Madzhab) and local Halal standards. 15

16

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


1 SCOPE 17

18

This standard prescribes practical guidelines for the Halal cosmetic and personal care 19

industry. It serves as a basic requirement for cosmetic and personal care industry in 20

managing product formulation, procurement, receiving, production, storage and distribution 21

through the organisation and the supply chain in compliance with the general principles of 22

Shariah. 23

24

This standard is applicable to activities encompassing places, institutions and companies 25

responsible for cosmetic and personal care production. 26

27

It is not applicable to materials handling covered under IHIAS 0100:2010 (Logistics) and 28

DIHIAS 0300 (Laboratory Testing and Analysis – to be published in 2011). 29

30

31

2 NORMATIVE REFERENCES 32

33

The following referenced documents are indispensable for the application of this standard. 34

MS 2200: Part 1:2008, Islamic consumer goods - Part 1: Cosmetic and personal care - 35

General guidelines. 36

MS 1900:2005, Quality Management Systems – Requirements from Islamic Perspectives. 37

ASEAN Guidelines for Cosmetic Good Manufacturing Practice, Appendix VI 38

National Pharmaceutical Control Bureau, Malaysia, Guidelines on Cosmetic Good 39

Manufacturing Practice. 40

ISO 9001 (R):2008, Quality Management Systems – Requirements 41

IHIAS 0100:2010, ICCI-IHI Alliance Halal Standard – Logistics (First Edition) 42

DIHIAS 0300, ICCI-IHI Alliance Draft Halal Standard – laboratory Testing and Analysis 43

(First Edition to be published in 2011) 44

45

46

47

3 Definitions 48

49

For the purposes of this standard, the following definitions apply. 50

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


51

3.1 Shariah 52

Islamic Law that covers both matters of belief (aqidah) and Jurisprudence – the theory or 53

philophy of law (fiqh). 54

55

NOTE The sources of Islam are the Sacred Book (Quran), the sayings of the Prophet Mohammad peace be upon 56

him (Sunnah), consensus (ijma) and anology (Qiyas). 57

58

Islam is perceived as comprising 3 basic elements; 59

60

i. AQIDAH : concerns all forms of faith and belief by Muslim in Allah the Almighty God 61

and His Will 62

63

ii. AKHLAK : concerns behaviour, attitude and work ethics with which a Muslim 64

performs his practical action. 65

66

iii. SHARIAH : concerns all forms of practical actions by a Muslim manifesting his faith 67

and belief. 68

69

Shariah is defined as the practical aspects of a Muslim’s daily life which comprises of 2 parts, 70

71

i) IBADAT : concerns the practicalities of worship to Allah (man-to-Allah relationship) 72

73

ii) MUAMALAT : concerns the practicalities of various daily life routines (man-to-man 74

relationship) 75

76

3.2 Halal 77

78

Things or actions, that is permissible or lawful under Shariah. 79

80

3.3 Non-Halal/Haram 81

82

Things or actions that are not classified as Halal according to this standard, and things or 83

actions that are forbidden or unlawful under Shariah. 84

85

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


3.4 Shubhah 86

87

Things or actions that are doubtful, and its status is not definitely known whether it is Halal 88

of Haram (e.g the nature of raw material used in production). 89

90

3.5 Najs 91

92

3.5.1 Najs according to Shariah are: 93

94

a) things that are themselves not permissible such as pig and all its derivatives, blood and 95

carrion; 96

b) any liquid and objects discharged from the orifices of human beings or animals such as 97

urine, excrement, blood, vomit, pus, sperm and ova of pigs and dogs except sperm and 98

ova of other animals; 99

c) carrion or Halal animals that are not slaughtered according to Shariah 100

d) Halal products that come into direct contact (contaminated) with things that are najs by 101

Shariah 102

103

NOTE Adapted from MS 2200:Part 1:2008 104

105

3.5.2 There are two types of najs relevant to the cosmetics and personal care industry. 106

107

3.5.2.1 Severe najs which is considered as Mughallazah, namely pig and dog and its liquid, 108

objects discharged from their orifices, descendants and derivatives. 109

110

3.5.2.2 Medium najs, which is considered as Mutawassitah, namely alcoholic beverages 111

(khamar), carrion, or Halal animals that are not slaughtered according to the Shariah, blood, 112

vomit, pus, liquid and objects discharged from the orifices, etc. 113

114

3.6 The organisation 115

116

Any commercial cosmetic or personal care manufacturing establishment that produces 117

cosmetic or personal care products. 118

119

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


3.7 Ritual cleansing 120

121

Process specified to follow by Shariah to remove severe najs materials. In some cases the 122

process must ensure complete elimination of residues, smell and/or colour. 123

124

NOTE Ritual cleansing practices may differ under the four (4) Schools of Thought when there is contamination 125

by severe najs. 126

127

3.8 Batch 128

A quantity of any cosmetic product produced in a given cycle of manufacture that is uniform 129

in character and quality. 130

131

3.9 Bulk Product 132

A processed product that will have to undergo the packaging operation in order to become a 133

finished product. 134

135

3.10 Calibration 136

Combination of checking an instrument and adjusting it to bring it within its limits for 137

accuracy according to recognised standards. 138

139

3.11 Cosmetics and personal care 140

Any substance or mixture of substances, manufactured, sold or represented for use in 141

cleansing, improving or altering the complexion, skin, hair or teeth and includes deodorants 142

and perfumes. The products are not being presented as treating or preventing disease in 143

human beings. 144

145

This definition includes (but is not limited to) soap, grooming products for animals, and 146

cosmetics used by professional aesthetic services (e.g. facial masks, manicure preparations, 147

hair dye).This also encompasses bulk products used by institutional services (e.g. handsoap 148

in school restrooms). 149

150

3.12 Halal cosmetics and personal care 151

152

Halal cosmetics and personal care products, including accessories are products permitted 153

under Shariah and fulfil the following conditions: 154

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


a) Do not comprise or contain any human parts or ingredients derived from thereof; 155

b) Do not comprise of or contain any parts or substance derived from animals forbidden to 156

Muslims by Shariah, to use or to consume or from halal animal which are not 157

slaughtered according to Shariah; 158

c) Do not contain any materials or genetically modified organisms (GMO) which are 159

decreed as najs according to Shariah; 160

d) Are not prepared, processed, manufactured or stored using any equipment that is 161

contaminated with things that are najs according to Shariah; 162

e) During its preparation, processing or manufacturing, the product is not in contact and is 163

physically segregated from any materials that do not meet the requirements stated in 164

items a), b), c) or d); and 165

f) Do not harm the consumer or the user. 166

NOTE Adopted from MS2200:Part 1:2008 167

168

3.13 Documentation 169

All written procedures, instructions and records involved in the manufacture and quality 170

control of products. 171

172

3.14 Product 173

Any substance or preparation intended to be used, or capable or purported or claimed to be 174

capable of being used, in or for cleansing, improving, altering or beautifying the complexion, 175

skin, hair or teeth. 176

177

3.15 Raw Materials 178

Any ingredient to be used in the formulation and manufacturing of a cosmetic product. 179

180

3.16 Processing aids 181

182

A substance that is added to a product for its technical or functional effect in the processing 183

stage but is present in the finished product at insignificant levels and does not have any 184

technical or functional effect in that product. 185

186

187

4 REQUIREMENTS 188

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


189

4.1 Organisation, Qualification and Responsibilities 190

191

4.1.1 The organisation shall ensure they employ the adequate number of personnel 192

having knowledge, experience, skill and capabilities relevant to their assigned function. They 193

should be in good health and capable of handling the duties assigned to them. 194

195

4.1.2 The organisational structure of the company shall be such that the production and 196

the quality sections are headed by different persons, neither of whom shall be responsible 197

to the other. 198

199

4.1.3 The organisation shall ensure that the head of production is adequately trained and 200

experienced in cosmetic manufacturing. He should have authority and responsibilities to 201

manage production of products covering operations, equipment, production personnel, 202

production areas and records. 203

204

4.1.4 The organisation shall ensure that the head of quality should be adequately trained 205

and experienced in the field of quality system duties such as establishment, verification and 206

implementation of all quality system procedures. He should have the authority to 207

designate/assign, when appropriate, personnel to approve starting materials, intermediates, 208

bulk and finished products that meet the specification or to reject those which do not 209

conform to the relevant specification or which were not manufactured in accordance with 210

approved procedures and under the defined conditions. 211

212

4.1.5 The organisation shall ensure that the responsibilities and authority of key personnel 213

are clearly defined. 214

215

4.1.6 The organisation shall ensure that there is an adequate number of trained personnel 216

appointed to execute direct supervision in each section of the production and quality control 217

unit. 218

219

220

221

222

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


223

224

225

226

227

228

229

230

231

232

233

234

235

236

237

238

239

240

241

242

243

244

245

246

247

248

249

Figure 4.1: Generic cosmetics and personal care process flow 250

251

NOTE 1 The process flow above may differ depending on the type of products the organisation manufactures 252

NOTE 2 * Indicates Halal Critical Control Point (HCCP) 253

254

4.1.7 The organisation should follow the Halal Critical Control Point for cosmetics and 255

personal care listed below: 256

HCCP 1 Product formulation 257

*RAW MATERIALS AND

PACKAGING STORAGE

DOCUMENTATION AUDIT

*SUPPLIER OF

RAW MATERIALS

LABORATORY

EQUIPMENT

CALLIBRATION

c

*LOGISTICS

WASTE WATER

TREATMENT WAREHOUSING

SUPPLIER OF PACKAGING

MATERIALS

PRIMARY SUPPLY CHAIN PROCESS

MANUFACTURING

PROCESSING

- MAKING

- FILLING

- HANDLING

SECONDARY SUPPLY CHAIN

PROCESS

*PRODUCT

FORMULATION

RAW MATERIAL LABORATORY

TESTING (OPTIONAL)

FINISHED PRODUCT

STORAGE

RETAILER /

CONSUMER

HCCP 1

HCCP 2

HCCP 3

HCCP 4

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


HCCP 2 Supplier of raw materials 258

HCCP 3 Raw materials and packaging storage 259

HCCP 4 Logistics 260

261

NOTE For logistics, refer to IHIAS 0100:2010, ICCI-IHI Alliance Halal Standard, Logistics 262

263

4.2 Training 264

265

4.2.1 The organisation shall ensure that all personnel directly involved in the 266

manufacturing activities is appropriately trained in manufacturing operations in accordance 267

to good manufacturing practice (GMP) principles. Special attention should be given to 268

training of personnel working with any hazardous materials. 269

270

4.2.2 The organisation should ensure that training in GMP is conducted on a continuous 271

basis. 272

273

4.2.3 The organisation shall ensure that records of training are maintained and its 274

effectiveness assessed periodically. 275

276

4.3 Premises 277

278

4.3.1 The organisation shall ensure that the premises for manufacturing are suitably 279

located, designed, constructed and maintained. 280

281

4.3.2 The organisation shall ensure that effective measures are taken to avoid any 282

contamination from the surrounding environment and from pests. 283

284

4.3.3 Household products containing non-hazardous materials/ingredients and cosmetic 285

products can share the same premises and equipment. . The organisation shall ensure that 286

due care is exercised to prevent cross contamination and risk of mix-up. Painted lines, plastic 287

curtains and flexible barriers in the form of rope or tape may be employed to prevent mix-288

up. 289

290

4.3.4 The organisation shall ensure that appropriate changing rooms and facilities are 291

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


provided. Toilets should be separated from the production areas to prevent product 292

contamination/cross contamination. 293

294

4.3.5 The organisation should ensure that these defined areas are provided for, wherever 295

possible and applicable: 296

a) Materials receiving 297

b) Materials sampling 298

c) Incoming goods and quarantine 299

d) Starting materials storage 300

e) Weighing and dispensing 301

f) Processing 302

g) Storage of bulk products 303

h) Packaging 304

i) Quarantine storage before final release of products 305

j) Storage of finished products 306

k) Loading and unloading 307

l) Laboratories 308

m) Equipment washing 309

310

4.3.6 The organisation should ensure that walls and ceilings, where applicable, are 311

smooth and easy to maintain. The floor in the processing areas should have a surface that is 312

easy to clean and sanitise. 313

314

4.3.7 The organisation should ensure that drains are of adequate size and should have 315

trapped gullies and proper flow. Open channels should be avoided where possible, but if 316

required they should be able to facilitate cleaning and disinfection. 317

318

4.3.8 The organisation shall ensure that air intakes and exhausts and associated pipework 319

and ducting, when applicable, are installed in such a way as to avoid product contamination. 320

321

4.3.9 The organisation shall ensure that buildings are adequately lit and properly 322

ventilated appropriate to the operations. 323

324

4.3.10 The organisation shall ensure that pipework, light fittings, ventilation points and 325

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


other services in manufacturing areas are installed in such a way as to avoid uncleanable 326

recesses and run outside the processing areas. 327

328

4.3.11 The organisation should ensure that laboratories are physically separated from the 329

production areas. 330

331

4.3.12 The organisation shall ensure that storage areas have adequate space with suitable 332

lighting arranged and equipped to allow dry, clean and orderly placement of stored 333

materials and products. 334

335

4.3.13 The organisation should ensure that storage areas are suitable for effective 336

separation of quarantined materials and products. Special and segregated areas should be 337

available for storage of flammable and explosive substances, highly toxic substances, 338

rejected and recalled materials or returned goods. 339

340

4.3.14 The organisation shall ensure that special storage conditions e.g. temperature, 341

humidity and security, where required, are provided. 342

343

4.3.15 The organisation should ensure that storage arrangements permit separation of 344

different labels and other printed materials to avoid mix-up. 345

346

4.4 Equipment 347

348

The organisation shall ensure that equipment are designed and located to suit the 349

production of the product. 350

351

4.4.1 Design and Construction 352

353

4.4.1.1 The organisation shall ensure that the equipment surfaces coming into contact with 354

any in-process material does not react with or adsorb the materials being processed. 355

356

4.4.1.2 The organisation shall ensure that the equipment does not adversely affect the 357

product through leaking valves, lubricant drips and through inappropriate modifications or 358

adaptations. 359

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


360

4.4.1.3 The organisation shall ensure that equipments are easily cleaned. 361

362

4.4.1.4 The organisation shall ensure that equipment used for flammable substances are 363

explosion proof. 364

365

4.4.2 Installation and Location 366

367

4.4.2.1 The organisation shall ensure that equipments are located to avoid congestion and 368

are properly identified to assure that products do not become admixed or confused with 369

one another. 370

371

4.4.2.2 The organisation shall ensure that water, steam, and pressure or vacuum lines, 372

where applicable, are installed so as to be easily accessible during all phases of operation. 373

They should be clearly identified. 374

375

4.4.2.3 The organisation shall ensure that support system such as heating, ventilation, air 376

conditioning, water (such as potable, purified, distilled), steam, compressed air and gases 377

(example: nitrogen) function as designed and identifiable. 378

379

4.4.3 Maintenance 380

381

The organisation shall ensure that weighing, measuring, testing and recording equipment 382

are serviced and calibrated regularly and all records are maintained. 383

384

4.4.4 Sanitation and Hygiene 385

386

The organisation shall ensure that sanitation and hygiene are practiced to avoid 387

contamination of the manufacturing of products. It shall cover personnel, premises, 388

equipment/apparatus and production materials and containers. 389

390

4.4.5 Management and staff 391

392

4.4.5.1 The organisation shall ensure that personnel are healthy to perform their assigned 393

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


duties. Regular medical examination must be conducted for all production personnel 394

involved with manufacturing processes. 395

396

4.4.5.2 The organisation shall ensure that personnel practice good hygiene practice (GHP). 397

398

4.4.5.3 The organisation shall ensure that any personnel shown at any time to have an 399

apparent illness or open lesions that may adversely affect the quality of products are not 400

allowed to handle raw materials, packaging materials, in-process materials, and finished 401

products. 402

403

4.4.5.4 The organisation shall ensure that personnel are instructed and encouraged to 404

report to their immediate supervisor any conditions (plant, equipment or personnel) that 405

they consider may adversely affect the products. 406

407

4.4.5.5 The organisation shall ensure that direct physical contact with the product is 408

avoided to ensure protection of the product from contamination. Personnel should wear 409

protective and clean attire appropriate to the duties they perform. 410

411

4.4.5.6 The organisation shall ensure that smoking, eating, drinking and chewing, food, 412

drinks and smoking materials and other materials that might contaminate are not permitted 413

in production, laboratory, storage or other areas where they might adversely affect product 414

quality. 415

416

4.4.5.7 The organisation shall ensure that all authorised personnel entering the production 417

areas practice good personal hygiene including proper attire. 418

419

4.4.6 Personnel hygiene, sanitation and pest control 420

421

4.4.6.1 The organisation shall ensure that adequate washing and well-ventilated toilet 422

facilities are provided for personnel and separated from the production area. 423

424

4.4.6.2 The organisation should ensure that suitable locker facilities are provided at 425

appropriate locations for the storage of employees’ clothing and personal belongings. 426

427

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


4.4.6.3 The organisation shall ensure that waste material is regularly collected in suitable 428

receptacles for removal to collection points outside the production area. 429

430

4.4.6.4 The organisation shall ensure that rodenticides, insecticides, fumigating agents and 431

sanitising materials does not contaminate equipment, raw materials, packaging materials, 432

in-process materals or finished products. 433

434

4.4.7 Equipment and Apparatus 435

436

4.4.7.1 The organisation shall ensure that equipment and utensils are kept clean. 437

438

4.4.7.2 The organisation should ensure that compressed air and brushes are used with care 439

and avoided if possible, as they increase the risk of product contamination. 440

441

4.4.7.3 The organisation shall ensure that standard operating procedures are followed for 442

cleaning and sanitising of major machines. 443

444

445

5 COSMETICS AND PERSONAL CARE PRODUCTION 446

447

5.1 Raw Materials 448

449

5.1.1 The organisation shall ensure the following for each raw material (including 450

additives and technological additives) utilised to produce ingredients: 451

a) the name and address of the supplier of the raw material; 452

b) information of the production or process from which the raw material is derived; 453

c) a risk assessment for each raw material, identifying potential hazards and the means by 454

which these hazards are controlled by the supplier, the organisation or both parties. 455

456

5.1.2 Sources of halal cosmetics and personal care; 457

a) sources derived from halal animals, land animals’ fur, hair and related material which 458

were harvested while the animals are still alive are halal. 459

b) sources derived from eggs that are from animals which are not najs are halal 460

c) all aquatic animals that are halal for consumption can be sources for cosmetic and 461

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


personal care. 462

d) sources derived from plants and microorganisms are halal for use except those that are 463

hazardous and/mixed with materials that are decreed as najs. 464

e) all sources from the soil, water and its by products are halal for use except those that 465

are hazardous and/mixed with materials that are decreed as najs. 466

f) materials that contain alcohol excluding alcoholic drinks (khamr) are permissible. 467

g) materials that are produced synthetically are halal except those that are hazardous 468

and/mixed with materials that are decreed as najs. 469

470

NOTE Adopted from MS2200:Part 1:2008 471

472

5.2 Starting materials 473

474

5.2.1 Water 475

476

5.2.1.1 The organisation shall ensure that water production equipment and water systems 477

supply quality water. Water systems should be sanitised according to well-established 478

procedures. 479

480

5.2.1.2 The organisation shall ensure that the chemical and microbiological quality of water 481

used in production is monitored regularly, according to written procedures and any anomaly 482

should be followed by corrective action. 483

484

5.2.1.3 The organisation shall ensure that the choice of method for water treatment such as 485

deionization, distillation or filtration depends on product requirement. The storage as well 486

as delivery system should be properly maintained. 487

488

5.3 Verification Materials 489

490

5.3.1 The organisation shall ensure that all deliveries of raw materials and packaging 491

materials are checked and verified for their conformity to specifications and be traceable to 492

the product. 493

494

5.3.2 The organisation shall ensure that samples of raw materials are physically checked 495

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


for conformity to specifications prior to release for use. The raw materials should be clearly 496

labeled. All goods must be clean and checked for appropriate protective packing to ensure 497

no leakage, perforation or exposure. 498

499

5.4 Rejected Materials 500

501

The organisation shall ensure that deliveries of raw materials that do not comply with 502

specification are segregated and disposed according to standard operating procedures. 503

504

5.5 Batch Numbering System 505

506

5.5.1 The organisation shall ensure that every finished product bear a production 507

identification number which enables the history of the product to be traced. 508

509

5.5.2 The organisation shall ensure that the batch numbering system is specific for the 510

product and a particular batch number shall not be repeated for the same product in order 511

to avoid confusion. 512

513

5.5.3 The organisation shall ensure that the batch number is printed on the immediate 514

and outer container of the product. 515

516

5.6 Weighing and Measurement 517

518

5.6.1 The organisation shall ensure that weighing is carried out in the defined areas using 519

calibrated equipment. 520

521

5.6.2 The organisation shall ensure that all weighing and measurement carried out is 522

recorded and, where applicable, counterchecked. 523

524

5.7 Procedure and Processing 525

526

5.7.1 The organisation shall ensure that all starting materials used are approved according 527

to specifications. 528

529

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


5.7.2 The organisation shall ensure that all manufacturing procedures are carried out 530

according to written procedures. 531

532

5.7.3 The organisation shall ensure that all required in-process controls are carried out 533

and recorded. 534

535

5.7.4 The organisation shall ensure that bulk products are properly labeled until approved 536

by Quality control, where applicable. 537

538

5.7.5 The organisation shall ensure that particular attention is paid to problem of cross-539

contamination in all stages of processing. 540

541

5.7.6 The organisation shall ensure that the processes meet the following requirements: 542

a) all processing lines, tools and utensils are dedicated for halal production only; 543

b) the product or its ingredients do not contain any non-halal or najs component; 544

c) the product is prepared, processed or manufactured using equipment and facilities that 545

are free from contamination with najs; 546

d) throughout its process, the product or its ingredients shall be physically separated from 547

anything that is decreed as najs. 548

549

5.8 Dry Products 550

551

The organisation shall ensure that handling of dry materials and products is given special 552

attention. Where possible, dust-containing production system, central vacuum system or 553

other suitable methods should be employed. 554

555

5.9 Wet Products 556

557

5.9.1 The organisation shall ensure that liquids, creams and lotions are produced in such a 558

way as to protect the product from microbial and other contamination. 559

560

5.9.2 The organisation should ensure the use of closed systems of production and 561

transfer. 562

563

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


5.9.3 The organisation should ensure that care is taken to ensure that pipe-lines used for 564

delivery of ingredients or bulk products systems are easy to clean. 565

566

5.10 Labelling and Packaging 567

568

5.10.1 The organisation shall ensure that the packaging line is inspected for clearance prior 569

to operation. Equipment should be clean and functional. All materials and products from 570

previous packaging operation should have been removed. 571

572

5.10.2 The organisation shall ensure that samples are taken and checked at random during 573

labeling and packaging operations. 574

575

5.10.3 The organisation shall ensure that each labeling and packaging line should be clearly 576

identified to avoid mix-up. 577

578

5.10.4 The organisation shall ensure that excess labels and packaging materials should be 579

returned to store and recorded. Any rejected packaging materials should be disposed off 580

accordingly. 581

582

5.10.5 The organisation shall ensure that the packaging material does not contain any raw 583

materials that are considered hazardous to human health. 584

585

5.10.6 The organisation shall ensure that the products are packed following the 586

requirements below: 587

a) packaging materials are not prepared, processed or manufactured using equipment or 588

raw materials that are contanimated with or made from things that are najs; 589

b) during its preparation, processing, storage and transportation, it shall be physically 590

separated from any other things that do not meet the requirements stated in a) or any 591

other things that is najs. 592

593

5.10.7 The organisation shall ensure that each container is marked legibly and indelibly and 594

the information on the label shall be consistent with the labelling requirements in the 595

country of export. 596

597

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


5.10.8 The organisation shall ensure that labelling does not contravene with the principles 598

of Shariah and does not display indecent elements which are against Shariah. 599

600

5.11 Finished Product: Quarantine and Delivery to Finished Stock 601

602

The organisation shall ensure that all finished products are approved by Quality Control prior 603

to release. 604

605

606

6 QUALITY CONTROL 607

608

6.1 Quality control system 609

610

6.1.1 The organisation shall ensure that quality control system assures that products 611

contain the correct materials of specified quality and quantity and area manufactured under 612

proper conditions according to standard operation procedures. 613

614

6.1.2 The organisation shall ensure that quality control involves sampling, inspecting and 615

testing of starting materials, in process, intermediate, bulk, and finished products. It also 616

includes, where applicable, environmental monitoring programs, review of batch 617

documentation, sample retention program, stability studies and maintaining correct 618

specifications of materials and products. 619

620

6.2 Reprocessing 621

622

6.2.1 The organisation shall ensure that the methods of reprocessing are evaluated to 623

ensure that they do not affect the quality of the product. 624

625

6.2.2 The organisation shall ensure that additional testing of any finished product which 626

has been reprocessed is performed. 627

628

6.3 Returned Products 629

630

6.3.1 The organisation shall ensure that returned products are identified and stored 631

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


separately either in an allocated area or segregated by moveable barrier such as rope or 632

tape. 633

634

6.3.2 The organisation shall ensure that all returned products are tested if necessary, in 635

addition to physical evaluation before being released for distribution. 636

637

6.3.3 The organisation shall ensure that returned products which do not comply with the 638

original specification are rejected. 639

640

6.3.4 The organisation shall ensure that rejected products are disposed according to 641

appropriate procedures. 642

643

6.3.5 The organisation shall ensure that records of returned products are maintained. 644

645

7 DOCUMENTATION 646

647

7.1 Document system 648

The organisation shall ensure that the documentation system adheres to the requirements 649

below: 650

a) documentation system should include the complete history of each batch, from starting 651

materials to finished products. The system should record executed activities for 652

maintenance, storage, quality control, primary distribution and other specific matters 653

related to GMP. 654

b) there is a system in place for preventing the use of any superseded document. 655

c) If an error is made or detected on a document, the organisation shall ensure that it is 656

corrected in such a manner that the original entry is not lost and correction is made 657

close to the original entry, initialed and dated. 658

d) that documents bearing instructions are clearly written step by step. 659

e) documents are dated and authorised 660

f) documents are readily available to relevant parties. 661

662

7.2 Specifications 663

664

7.2.1 The organisation shall ensure that all specifications are approved by authorised 665

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


personnel. 666

667

7.2.2 The organisation shall ensure that raw and packaging material specifications include: 668

a) Name of material 669

b) Description of material 670

c) Testing parameters and acceptance limits 671

d) Technical drawings, where applicable 672

e) Special precautions, if necessary 673

674

7.2.3 The organisation shall ensure that bulk and finished product specifications include: 675

a) Name of product 676

b) Description 677

c) Physical properties 678

d) Chemical assay and/or microbiological assays and their acceptance limits; if necessary. 679

e) Storage conditions and safety precautions, if necessary. 680

681

7.3 Documents for Production 682

683

7.3.1 Master Formula 684

685

The organisation shall ensure that the Master formula is available upon request. This 686

document should contain the following information: 687

a) Product name and product code/number 688

b) Intended packaging materials and storage conditions 689

c) List of raw materials used, whether they remain unchanged or become altered. 690

d) List of raw materials used. 691

e) List of equipment used. 692

f) In-process controls with their limits in processing and packaging, where applicable. 693

694

7.3.2 Batch Manufacturing Record 695

696

The organisation shall ensure that Batch Manufacturing Record (BMR) is prepared for each 697

batch of product. 698

699

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


Each BMR should include the following: 700

a) Name of product 701

b) Batch formula 702

c) Brief manufacturing process 703

d) Batch or code number 704

e) Date of the start and finish of processing and packaging 705

f) Identity of individual major equipment and lines or location used 706

g) Records of cleaning of equipment used for processing as appropriate 707

h) Packaging line clearance inspection records 708

i) Any sampling performed during various steps of processing 709

j) Any investigation of specific failure or discrepancies 710

k) Results of examinations on packed and labeled products 711

712

7.3.3 Records for Quality Control 713

714

The organisation shall ensure that records for each testing, assay result and release or 715

rejection of starting materials, intermediates, bulk and finished product are maintained. 716

717

These records may include: 718

a) Date of test 719

b) Identification of the material 720

c) Supplier name 721

d) Date of receipt original batch number if any 722

e) Batch number 723

f) Quality control number 724

g) Quantity received 725

h) Date of sampling 726

i) Quality control results 727

728

729

8 INTERNAL AUDITS 730

731

An internal audit consists of an examination and assessment of all or part of a quality system 732

with the specific purpose of improving it. An internal audit may be conducted by outside or 733

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


independent specialists or a team designated by the management for this purpose. Such 734

audits may also be extended to suppliers and contractors, if necessary. A report should be 735

made at the completion of each quality audit. 736

737

738

9 STORAGE 739

740

9.1 Storage Areas 741

742

9.1.1 The organisation shall ensure that storage areas are of sufficient capacity to allow 743

orderly storage of the various categories of materials and products such as starting and 744

packaging materials, intermediates, bulk and finished products, products in quarantine, and 745

released, rejected, returned or recalled products. 746

747

9.1.2 The organisation shall ensure that storage areas are designed or adapted to ensure 748

good storage conditions. They should be clean, dry and well-maintained. Where special 749

storage conditions are required (temperature and humidity) these should be provided, 750

checked and monitored. 751

752

9.1.3 The organisation shall ensure that receiving and dispatch bays protect materials and 753

products from weather. Reception areas should be designed and equipped to allow 754

incoming materials to be cleaned if necessary before storage. 755

756

9.1.4 The organisation shall ensure that storage areas for quarantine products are clearly 757

demarcated. 758

759

9.1.5 The organisation shall ensure that the sampling area for starting materials is 760

provided to prevent contamination. 761

762

9.1.6 The organisation shall ensure that hazardous materials are safely and securely 763

stored. 764

765

9.2 Stock Handling and Control 766

767

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


9.2.1 Receiving Products 768

769

9.2.1.1 The organisation shall ensure that each incoming delivery is checked against the 770

relevant documentation and physically verified by label description, type and quantity upon 771

receipt. 772

773

9.2.1.2 The organisation shall ensure that the consignment is carefully inspected for defects 774

and damage. Records should be retained for each delivery. 775

776

9.2.3 Control 777

778

9.2.3.1 The organisation shall ensure that records are maintained showing all receipts and 779

issues of products. 780

781

9.2.3.2 The organisation shall ensure that the principle of stock rotation (first in – first out) 782

is observed. 783

784

9.2.3.3 The organisation shall ensure that all labels and containers of products are not 785

altered, tampered or changed. 786

787

788

10 CONTRACT MANUFACTURING AND ANALYSIS 789

790

10.1 The organisation shall ensure that the conditions of contract manufacturing and 791

analysis are clearly defined, agreed, and controlled so as to avoid misunderstandings, which 792

could result in a product or work of unsatisfactory quality. All aspects of contracted work 793

should be specified to obtain a quality product conforming to the agreed standards. 794

795

10.2 The organisation shall ensure that there is a written contract between the principal 796

and the contract manufacturer to clearly establish the duties and responsibilities of each 797

party. 798

799

800

11 COMPLAINTS 801

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


802

11.1 The organisation shall ensure that there is a person designated to handle complaints 803

and decide on measures to be taken. 804

805

11.2 The organisation shall ensure that there are written procedures describing the 806

action to be taken, including the need to consider a recall, in the case of a complaint 807

involving a possible product defect. 808

809

11.3 The organisation shall ensure that complaints involving product defect are recorded 810

with all the original details and investigated. 811

812

11.4 If a product defect is discovered or suspected in a batch, the organisation should 813

ensure that other batches are checked in order to determine whether they are also affected. 814

In particular, other batches that may contain reprocessed products from the defective batch 815

should be investigated. 816

817

11.5 The organisation should ensure that appropriate follow-up action, possibly including 818

product recall, are taken after investigation and evaluation of the complaint. 819

820

11.6 The organisation shall ensure that all the decisions and measures taken as a result of 821

a complaint are recorded and referenced to the corresponding batch records. 822

823

11.7 The organisation shall ensure that complaint records are regularly reviewed for an 824

indication of specific or recurring problems that require attention and might justify the recall 825

of marketed products. 826

827

11.8 The organisation shall ensure that the complaint authority is informed if a 828

manufacturer is considering action following possibly faulty manufacture and product 829

deterioration, which may lead to serious safety issues. 830

831

12 PRODUCT RECALLS 832

833

12.1 The organisation shall ensure that there is a system of recall from the market of 834

products known or suspected to be defective. 835

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


836

12.2 The organisation shall ensure that there is a designated person responsible for the 837

execution and co-ordination of recalls, as well as sufficient personnel to handle all aspects of 838

recalls with the appropriate degree of urgency. 839

840

12.3 The organisation shall ensure that there is written procedures for recall that are 841

reviewed regularly. Recall operations should be capable of being initiated promptly. 842

843

12.4 The organisation shall ensure that the primary distribution records are readily 844

available to the person(s) responsible for recalls, and they should contain sufficient 845

information of distributors. 846

847

12.5 The organisation shall ensure that the progress of the recall process is recorded and 848

a final report issued, including reconciliation between the delivered and recovered 849

quantities of the products. 850

851

12.6 The organisation shall ensure that the effectiveness of the arrangements for recalls 852

is evaluated from time to time. 853

854

A written instruction should be established to ensure recalled products are stored securely 855

in a segregated area while awaiting decision. 856

857

858

13 LEGAL REQUIREMENTS 859

860

The organisation shall ensure that all activities and products shall in other aspects comply 861

with the requirements of the relevant legislations currently in force. 862

863

864

14 MARKING 865

866

The organisation shall ensure that there is a clearly recognisable HALAL mark in accordance 867

with the Halal requirements on the product itself and/ or packaging. 868

869

21-06-2010 IHI/TC8/DIHIAS 08 - 00600 of 32


870

15 HALAL COSMETICS AND PERSONAL CARE CERTIFICATION 871

872

15.1 Organisation 873

874

In order to be Halal certified, all Halal cosmetics and personal care manufacturers shall be 875

audited by a competent authority and certified by a recognised Halal certification body. In 876

the event where Halal and non-Halal cosmetic is prepared within the same premise, then 877

only the area where Halal cosmetic and personal care is prepared or served may be certified 878

provided sufficient segregation is implemented. 879

880

15.2 Compliance 881

882

For finished products deemed to conform to this standard, it shall comply with Clauses 4 to 883

15 of this standard. This shall be verified through inspection by an accredited Halal 884

Certification body. 885

886

15.3 Certification mark 887

888

A facility and service, upon approval by a recognised Halal certification body, may be 889

accompanied with a Halal certificate of that authority provided the facility and/or service 890

conforms to the requirements of this standard. 891

892

For a dedicated Halal facility, the Halal certificate may appear on the outside of the facility. 893

For a non-dedicated Halal facility, the Halal certificate shall not be displayed. The Halal 894

certificate shall be kept in the office and shall be made available up on inspection by an 895

accredited Halal Certification Body. 896

897

L1: DRAFT INTERNATIONAL DIHIAS 08 - 00600 Date Reference...

Documents

Transcript of L1: DRAFT INTERNATIONAL DIHIAS 08 - 00600 Date Reference...