Specifications

• Specifications are the quality targets to achieve• Specifications describe the quality parameters

1. Raw Materials Specifications2. Packaging Materials Specifications3. Intermediate Product Specifications4. Bulk Product Specifications5. Finished Product Specifications

1. Raw materials (API / excipients) specifications –- Material name- Product code- Any alternative name or proprietary name- Physical description- Respective to reference limits for:

- Identity- Purity- Physical- Chemical characteristics

- Microbiological standards

Specifications

Microbiological standards

TAMC: Total Aerobic Microbial CountTYMC: Total Combined Yeasts/MoldsCFU: colony-forming unit

2. Packaging materials specifications – direct contact / no contact with theproduct

Specifications

Label Physical Specifications

• Dimensions and color scheme• Quality specifications

2. Packaging materials specifications – direct contact / no contact with theproduct

Specifications

Label Printed Information

• Product name• Trade mark• Active ingredient(s)• Strength • Quantity • Storage condition• Batch number• Manufacturing and expiry date• Price

• Manufacturing license number• Company name and address

2. Packaging materials specifications – direct contact / no contact with theproduct

Specifications

Carton Physical Specifications

• Dimensions and color scheme• Quality specifications

2. Packaging materials specifications – direct contact / no contact with theproduct

Specifications

Carton Printed Information

• Product name• Trade mark• Active ingredient(s)• Strength • Quantity • Storage condition• Batch number• Manufacturing and expiry date• Price

• Manufacturing license number• Company name and address• Dosage• Major warning• Other regulatory requirements

2. Packaging materials specifications – direct contact / no contact with theproduct

Specifications

Insert / Leaflet Physical Specifications

• Size and folds

Printed Information

• Special warning• All details as required by the local authority

2. Packaging materials specifications – direct contact / no contact with theproduct

Specifications

Measuring spoon Printed Information

• Material quality specification• dimension• fluid capacity• markings

2. Packaging materials specifications – direct contact / no contact with theproduct

Specifications

Immediate container Printed Information

• Material specifications• Size• Shape• drawing• control limits• Molding

2. Packaging materials specifications – direct contact / no contact with theproduct

Specifications

Closure Printed Information

• Material specifications• Size• drawing

Specifications

2. Immediate product specifications – important for IPQC

Intermediate stage Specifications

Granulation and drying

• Homogeneity of the content• Moisture content

Specifications

2. Immediate product specifications – important for IPQC

Intermediate stage Specifications

Tablet core for coated tablet • Shape• Size • Appearance• Hardness• Uniformity of weight • Dose content

• Dissolution / Disintegration • Moisture content • Abrasion resistance

Specifications

3. Bulk product specifications – important for finished productquality

• In-house specifications

• Release Specifications

• Registration Specifications

1. Registration specifications – the specifications that are registered fora product with the regulatory authority.

For example, lower limit and upper limit of API, expiry date, MRP etc.

Specifications

2. Release specifications – the specifications that a product mustsatisfy before it can be released to the market.

- Should be tighter than the registration specification

- To save the product failing in the market

- To maintain the potency of product during the shelf-life

Specifications

3. In-house specifications –• Tighter limit than the release specification• An advance alarm to the production department about necessary

corrective measures• Provides an extra protection to the company for marginal analytical

error.• Action can be taken before a batch falls outside the Release

Specifications (i.e. before rejection).

Specifications

Specifications

Specifications for Paracetamol

In-house limit Release limit Registration limit

API490 – 510 mg/tablet

480 – 525 mg/tablet

475 – 525 mg/tablet

Disintegration Not more than 7

minutesNot more than 10

minutesNot more than 15

minutes

Specifications

4. Finished product specifications –

Bulk product specification + Packaging specification

Procedures

• All written instructions of manufacturing, testing or release of aproduct

• Describes the way in which things should be done• Easy for the operators to understand.

• Any changes in the procedures should be duly authorized

• Standard Operating Procedures (SOP) and the ManufacturingInstructions (MI)

Personnel and Training

People Training

Learning

Assessment

Application

Monitoring

Components

Personnel and Training

A balanced team for a pharmaceutical operation includes graduatesfrom all disciplines, such as:

- Biochemistry- Chemistry- Engineering- Microbiology- Pharmacy etc.

Components – people

Personnel and Training

Training – purposes

Training and personnel development are inseparable. Carefullyconducted training program will ensure:

- Better understanding of the people/process/equipment- Uniformity and consistency in manufacturing- Higher quality attainment- Increased productivity- Better perfection in the employees skill.- Faster response

Training – included topicsTraining program designed for pharmaceutical industries must cover allimportant aspects of its functions:

• Direct effect of medicine on people’s health• Key manufacturing activities• Importance of personnel health and hygiene• Importance of safety precautions• Importance of cleanliness• Need for effective work system

Personnel and Training

• Importance of manufacturing and testing procedures• Problem of Faulty / Rejected batches• Role of Production, QA/QC and Engineering• Importance and the principle of GMP, validation, productivity

and profitability• How the non-compliance with standards and procedures will

affect patients/consumers, company and employee?

Personnel and Training

Personnel and Training

Training – modes

• Formal lecture• Symposium• Discussion groups• Workshop

• Must cover employees of all sections• Designed for various levels• Definite objectives

Training records of each staff

Personnel and Training

Ears Eyes EarsEyes

EarsEyesDiscussion

EarsEyesDiscussionApplication

+ + + + + + + + + + + + + + +

Various training aids for communication

Personnel and Training

• When information is received through eyes the retention is betterthan ears.

• Discussion and exchange of views generate thinking and itsapplication at the work place makes even better impact onretaining the information by fixing it more firmly in the minds.

Various training aids for communication

Personnel and Training

• Audiovisual systems like slides/tape presentation and video recordedprogram, are better rather than a simple class-room type lectures.

• Programmed question and answer training aids are also very valuable.

• Combining active learning methods will retain much moreinformation.

Various training aids for communication

32

Thank you

Mohammad Ahad A Khan, PhDAssistant Professor, Department of Pharmaceutical SciencesNorth South University, Bangladesh Room: SAC 1013email: mohammad.khan03@northsouth.eduCell: +880 17 0386 4707