brazil-rdc-no-167-2-july-2004

EMERGO SOUTH AMERICA LTDA. SIBS Qd. 02 | Cj. B, Lt. 13/14 | Brasília DF 71.736-202 | Brasil | Telefone: +55.61.3386.3166

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RESOLUTION - RDC Nº 167, JULY, 02, 2004.

The Board of the National Health Surveillance Agency, in exercise of the powers granted by

art. 11, item IV of the ANVISA Regulation approved by Decree No. 3029 of April 16, 1999, c / c art.

111, paragraph I b, § 1 of the Internal Regulation approved by Administrative Order No. 593 dated

August 25, 2000, republished in the Official Gazette of December 22, 2000, at a meeting held on June

28, 2004,

considering the Federal Law No. 6.360, dated September 23, 1976;

Having regard to Decree No. 686 of 27 August 1998 laying down the guidelines of Good

Manufacturing and Control for in vitro diagnostic products;

considering the Mercosur GMC Resolution No. 38/96, concerning the compliance of Good

Manufacturing Practices for establishments that manufacture or sell products for diagnostic use in

vitro,

adopts the following resolution of the Board and I, the Chairman, determine its publication:

Article 1 Establishing Guidelines for Inspection for compliance with Good Manufacturing

Practices for establishments that manufacture or market products for in vitro Diagnostic Use, to be

observed by the health authorities around the country, according to annex.

Article 2 This resolution comes into force on the date of its publication.

CLAUDIO MAIEROVITCH PESSANHA HENRIQUES

Emergo Group has translated this document from Portuguese to English as a service to the medical

device community. It is not an official translation provided by ANVISA. This translation may not be

reproduced online or in any other format without written permission from Emergo Group.


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ANEXX

CHECKLIST OF GOOD PRACTICE IN MANUFACTURING ESTABLISHMENTS AND CONTROL OF

PRODUCTS FOR IN VITRO DIAGNOSTIC USE

1 - ADMINISTRATION AND GENERAL INFORMATION

The establishment must submit any documentation that is required by the inspector.

Manufacturer Fractionator Importer

1.1 What´s the company Tax

ID Number?

INF INF INF

1.2 For whom the auditors are

assisted?

N N N

1.3 The responsible Technical

Director is present?

N N N

1.4 There is proof of inscription

of company's Technical

Director and the Board of

Health competent?

I I I

1.5 The company has

authorization of the

competent authority for

operation with regard to

location, environmental

protection and plant

safety?

I I I


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1.6 The plants of the buildings

were presented?

R R R

1.7 What is the number of

employees hired by the

company?

INF INF INF


employees who are directly

linked to the

administrative, sales and

production area of the

Company?

INF INF INF

1.9 Was presented the list of

products that are on sale

or not?

I I I

1.10 All these products are duly

registered at the Ministry

of Health?

I I I

1.11 The area occupied by the

company is appropriate for

the declared capacity?

INF INF INF

1.12 What's own production

capacity of each product

manufactured by the

company?

N N NC

1.13 There are manufacturing

contracts with third

parties?

What are the names of the

contractors?

INF INF INF


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1.14 Imports raw materials,

finished product, bulk,

semi-finished?

INF INF INF

1.15 Export supplies, finished

product, bulk, semi-

finished?

INF INF INF

1.A- EXTERNAL CONDITIONS


1.A.1 On the external side,

the buildings have

good conservation?

(no cracks, peeling

paint, leaks, etc?

R R R

1.A.2 Is there protection

against the entry of

rodents, insects, birds

or other animals?

N N N

1.A.3 The physical

conditions and state of

conservation of the

structure, walls and

roofs are appropriate?

R R R

1.A.4 The access roads are

adequate?

R R R


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1.B- INTERNAL CONDITIONS


1.B.1 The state of hygiene

and maintenance (no

holes and cracks, no

breaks,) is

appropriate?

N N N

1.B.2 The walls are well

preserved?

N N N

1.B.3 The state of hygiene is

adequate?

N N N

1.B.4 The ceilings are

appropriate and are in

good condition?

N N N

1.B.5 The sewers and

plumbing are in good

condition?

N N R

1.B.6 Is the lighting

adequate?

N N N

1.B.7 The electrical

installations are in

good condition, safe

N N N


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and proper use?

1.B.8 Have been noted

evidence of rodents,

insects, birds or other

animals?

INF INF INF

1.B.9 Is there a system and

procedure to combat

the presence of

rodents, insects, birds

or other animals? Who

is responsible for the

system? How often is

it applied? Check in

case it is.

N N N

conducted by a

contractor, what is the

frequency?

1.B.10 There is safety

equipment for fighting

fires? Access to fire

extinguishers and

hoses will be

available?

N N N

1.B.11 There is a permanent

health care plan and

emergency response

in case of sudden

illness or accident at

work?

INF INF INF

1.B.12 There are sufficient

toilets? Check the

cleanliness of them.

INF INF INF


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1.B.13 There are changing

rooms in sufficient

quantity? Check the

cleanliness of them.

INF INF INF

1.B.14 The staff uses the

uniform appropriate?

Check the conditions

of cleaning them.

R R INF

1.B.15 Is there a restaurant?

If not, where the

employees eat?

INF INF INF

1.B.16 There are water

fountains for drinking

water in sufficient

quantities and

appropriate places?

INF INF INF

1.B.17 There are identified

and appropriate

containers for

collection of waste?

They are cleaned

frequently?

INF INF INF

2- STORAGE AREA


2.1 The room temperature is

in line with the conditions

of storage of raw

I I I


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materials, bulk, semi

finished and finished

products?

2.2 The storage area

temperature and humidity

is controlled ?

Check the records at the

time of the audit.

I I I

2.3 There is need for cold

storage?

INF INF INF

2.4 Having cold room, its

temperature is controlled

and recorded?

I I I

2.5 What is the temperature

at the time of the audit?

R R R

2.6 How often are calibrated

the weighing scales?

Check the records.

R R NC

2.7 The storage disposition is

rational and correct in

order to preserve the

integrity and the identity

of the material?

N N N

2.8 The finished product is

properly stored separately

from the floor and walls to

facilitate the

accomplishment of tasks

of cleaning and hygiene,

and its conservation?

N N N


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2.9 There are guarantees of

separation of packaging

materials, packaging, raw

materials, bulk, semi

finished and the product

manufactured?

I I I

2.10 There is in a storage area

a quarantine system?

I I I


a system identification of

rejected products?

I I I


an identification system

for storing of tags, labels

and instruction manuals?

N N N

2.13 Explosive and flammable

products are stored in an

appropriate place?

N N N

2.14 It is approved by the

competent authority?

N N N

2.15 There is in the storage

area, separate locations,

closed by key and with

access restricted to

narcotic substances,

psychotropic, toxic or

similars when needed?

I I I

2.16 There are signs and verbal

communication about the

characteristics of

radioactivity, the risk of

N N N


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unhealthy conditions, way

of handling raw materials,

bulk, semi finished and

finished products as well

as how to act in case of

accidents?

2.A - RECEIVING AND STORAGE OF SUPPLIES

Fabricante Fracionador Importador

2.A.1 It's made in a storage

area an identification

system visual

examination of materials

at the reception to check

if they were damaged

during transportation?

N N NC

2.A.2 Is there a way to prove

that was followed the

cold chain during

transportation?

N N NC

2.A.3 The reception of the

material is documented?

N N NC

2.A.4 At each material

entrance, is registered a

number for each lot

received?

I I NC

2.A.5 Before the release by

Quality Control, the

materials remain in

I I NC


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quarantine properly

labeled and separated?

2.A.6 The approved product is

identified by a label

attached on the bottle

and not on the cover?

N N NC

2.A.7 Are obtained samples of

materials for quality

control in accordance

with appropriate and

reliable systems?

N N NC

2.A.8 The supplies are

identified as such

approved and

transferred to

appropriate storage

location?

N N NC

2.A.9 The expiry date and date

of review are indicated

on the label?

N N NC

2.A.10 The rejected products

are properly identified

and segregated?

I I NC

2.A.11 The available storage is



identity and integrity of

the supplies?

N N NC

2.A.12 Which system is used for

stock control? Is it

R R NC


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functional?

2.A.13 The packaging (drums,

barrels, boxes etc.).

which contain the

materials are well

closed? Are properly

identified?

N N NC

2.B- RECEPTION AND STORAGE OF FINISHED PRODUCTS


2.B.1 There is a entry system

of registering and stock

control of the finished

product?

N N N

2.B.2 The system of

registration and control of

shipment of the finished

product comprises a

corresponding correlation

sequential of lots, date of

entry and exit and the

observation of expiration

date?

N N N

2.B.3 The storage of finished

product, is realized with

due order and safety,

avoiding possible

confusion in the control

and shipping as well as

N N N


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handling accidents?

2.B.4 The available storage is



identity and integrity of

the finished products?

N N N

2.B.5 The expired products are

removed from the

warehouse and later

destroyed and / or

reprocessed, and this

procedure is properly

registered?

I I I

2.B.6 What is the company

policy regarding the sale

of products close to

expiration date? Verify

the compliance of the

policy and the existence

of records.

R R R

2.B.7 Inventories are

conducted periodically?

Are records of that?

INF INF INF

2.C- DEVOLUTIONS

Fabricante Fracionador Importador

2.C.1 There is an area that limits

or restricts the storage of

N N N


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returned products?

2.C.2 These products are

identified as such?

N N N

2.C.3 Are there responsables for

the decision making for its

due treatment?

N N N

2.C.4 The quality control is

informed about the returns

occur?

N N N

2.C.5 Are recorded the analysis

realized, results and

decisions taken?

N N N

2.C.6 After analysis of the

material, is processed its

destruction or reprocessing

as provided in procedures?

There are corresponding

records?

I I I

2.C.7 Os registros do

procedimento anterior são

anexados ao Registro

Histórico do Produto?

R R R

2.D- PRODUCTS MARKET REMOVAL

NOTE: It is defined as the primary distribution, delivery in a direct chain of marketing,

promotion and research, applied since the company that owns the product until the first receiver of

the same.


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2.D.1 There is a control

distribution of finished

products Check the list of

distributors.

N N N

2.D.2 The company establishes

and maintains

procedures for the

products removal?

N N N

2.D.3 Establishes and

maintains a system that

ensuring the correct

application of these

procedures?

N N N

2.D.4 There is a designated

responsible for the

coordination and

execution of the

procedure for product

removal?

N N N

2.D.5 If the person responsible

for performing this task

does not belong to the

Quality Control

Department, this

department is informed

of the operations

performed?

N N N

2.D.6 There are records of the

information of the

products market removal

N N N


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, as well as its causes?

2.D.7 In case of market

products removal for

non-compliance, the

competent authorities of

other countries are

reported immediately?

R R R

2.D.8 Immediate steps are

taken to remove the

product throughout the

territory in which it was

distributed?

There is registration?

I I I

2.D.9 The records of product

distribution at the

primary level are

available for quick action

from the market?

I I I

2.D.10 These records contain

information that allows

traceability and

identification of what are

the receivers resulting

from the primary

distribution?

N N N

2.D.11 There is a safe and

appropriate area for

storage of products

removed from the

market, and are properly

identified, while waiting

its destination?

N N N


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2.D.12 Existem registros sobre o

destino dos produtos

retirados do mercado ?

I I I

3- SYSTEM AND WATER INSTALLATIONS


3.1 The company uses

water, purified,

distilled, distilled or

sterile?

INF INF INF

3.A- POTABLE WATER


3.A.1 What is the origin of the

water used by the

company? Public System

- Artesian Wells - Semi

Artesian wells - Other.

Which ones?

INF INF INF

3.A.2 The company has water

tanks? How many? Which

material? What is the

capacity of these tanks?

INF INF INF

3.A.3 It's done some treatment INF INF INF


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before the water is

stored? What?

3.A.4 It made the cleaning of

the water tanks? How

often? There are records?

R R INF

3.A.5 They are made physical-

chemical controls? Which

ones? How often? There

are records?

N N INF

3.A.6 Microbiological controls

are made? Which ones?

How often? There are

records?

N N INF

3.A.7 Water sample is collected

from different parts of

the company, including

the fountains, to make a

microbiological control?

There are records?

N N INF

3.A.8 The piping used to

transport clean water is

in good condition of

cleaning and

conservation?

N N INF

3.B- PURIFIED WATER

Potable water is used as a power source for production systems of purified water? Which

system is used? Deionization or reverse osmosis?


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3.B.1- DEIONIZATION


3.B.1.1 The industry has

deionizer equipment for

production of purified

water? What is the

capacity in liters / hour?

It is preventive

maintenance made in

the system equipment ?

There are records?

INF INF NC

3.B.1.2 There is trained staff to

operate the system?

The responsable for this

operation is present?

INF INF NC

3.B.1.3 There is an operations

manual for the system?

It is used?

N N NC

3.B.1.4 The resins are

regenerated frequently?

There are records?

N N NC

3.B.1.5 The water that supplies

the deionizer is treated?

How?

INF INF NC

3.B.1.6 If the water that

supplies the chlorinated

deionizer is there a

system to remove the

chlorine before

R R NC


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deionizer? What?

3.B.1.7 There is a deposit for

deionized water? What

is the capacity? What is

the material used?

Is there any treatment

to prevent microbial

contamination? What is

the average

consumption?

R R NC

3.B.1.8 Physical chemical

controls are made?

What? How often? There

are records?

N N NC


controls are made?


are records?

N N NC

3.B.1.10 The transportation or

movement of deionized

water is done through

proper piping?

N N NC

3.B.1.11 The water produced is

used as raw material for

liquid products?

INF INF NC

3.B.1.12 Water is released by the

Quality Control before

being used?

N N NC

3.B.1.13 The purification system

is validated? There are

R R NC


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records?

3.B.2- REVERSE OSMOSIS


3.B.2.1 The industry has

reverse osmosis

equipment for

production of purified

water? It preventive

maintenance is made in

the system

equipaments? There are

records?

INF INF NC

3.B.2.2 What is the capacity in

liters / hour?

INF INF NC

3.B.2.3 The water that supplies

the system is treated?

INF INF NC

3.B.2.4 There is trained staff to

operate the system?

The operation

responsable is present?

INF INF NC

3.B.2.5 There is an operation


It is used?

R R NC

3.B.2.6 There is a deposit for

this water? What is the

R R NC


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capacity? What is the

material used? Is there

any treatment to avoid

microbial

contamination? What is

the average

consumption?


controls are made?


are records?

N N NC


controls are made?


are records?

N N NC

3.B.2.9 The transportation or

movement of water is

done through the

properly pipe?

N N NC

3.B.2.10 The water produced is


liquid products?

INF INF NC

3.B.2.11 Water is released by the


being used?

N N NC

3.B.2.12 The purification system

is valid? There are

records?

R R NC


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3. C- DISTILLED WATER / BIDISTILLED


3.C.1 The industry has

distillation equipment to

produce this kind of

water? It preventive

maintenance is made in

the system

equipaments? There are

records?

INF INF NC

3.C.2 What is the capacity in

liters / hour?

INF INF NC

3.C.3 The water that supplies

the distiller is it treated?

INF INF NC

3.C.4 There is trained staff to

operate the system? The

operation responsable is

present?

INF INF NC

3.C.5 There is an operations


It is used?

N N NC

3.C.6 There is a deposit for

this water? What is the

capacity? What is the

R R NC


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material used? Is there

any treatment to avoid

microbial contamination?

What is the average

consumption?

3.C.7 Physical chemical

controls are made?


are records?

N N NC

3.C.8 Physical chemical

controls are made?


are records?

N N NC

3.C.9 The transportation or

movement of water is

done through the

properly pipe?

N N NC

3.C.10 The water produced is


liquids and to control

quality?

INF INF NC

3.C.11 Water is released by the


being used?

N N NC

3.C.12 The purification system

is valid? There are

records?

R R NC


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3.D-STERILE WATER


3.D.1 The industry has

sterilization equipment

for the production of

sterile water? It

preventive

maintenance in the

system equipment is

made? There are

records?

INF INF NC

3.D.2 What is the capacity in

liters / hour?

INF INF NC

3.D.3 The water that

supplies the sterilizer

is treated? How?

INF INF NC

3.D.4 There is trained staff

to operate the system?

The responsable for

the operation is

present?

INF INF NC

3.D.5 There is an operations

manual for the

system? It is used?

N N NC


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3.D.6 Sterility controls are

made? What? How

often? There are

records?

I I NC

3.D.7 Water is released by


being used?

N N NC

3.D.8 The purification

system is valid? There

are records?

R R NC

4-PRODUCTION


4.1 Who is responsible for

producing?

INF INF NC

4.2 What is your professional

formation?

INF INF NC

4.3 Is there an organogram? INF INF NC

4.4 Number of staff

employed in the area.

The technical and

specialized staff is

enough?

INF INF NC

4.5 There is a training plan

for the staff?

R R NC


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4.6 If an employee presents

injury or illness that can

affect the quality or

safety of products, is he

kept out of contact with

them?

N N NC

4.7 If there is manufacturing

agreement with third

parties, which are the

products and what are

the respective volumes

of production?

INF INF NC

4.A-ORGANIZATION

4.A.1-STANDARD FORMULA


4.A.1.1 Is there a standard

formula for each product

manufactured?

I I NC

4.A.1.2 This standard formula is

prepared, reviewed and

approved by responsible

people and countersigned

by another responsible?

N N NC

4.A.1.3 There are written

procedures on how to

proceed when is

N N NC


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necessary to modify the

standard formula?

4.A.1.4 The standard formula

contains:

- Name, code or product

catalog number or of each

component?

I I NC

- Composition of each

component of the product

period of validity or

stability, storage

temperature?

- Quantity theory of the

product to be

manufactured?

4.A.1.5 There are detailed

instructions for all stages

of manufacture, place of

production and

equipments to be used?

N N NC

4.A.1.6 There is a equipaments

cleaning procedure?

N N NC

4.A.1.7 There is one responsible

for verifying the execution

of the cleaning equipment

used?

N N NC

4.A.1.8 There are clear and

detailed instructions

identifying the elaboration

steps that require the

intervention of quality

control for process control

N N


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and identification of the

person responsible and

date?

4.A.1.9 There are requirements to

attach the manufacture

order, registers, graphic

records of temperature,

pressure and humidity

when the procedure

requires control of them?

N N

4.A.1.10 Are there requirements to

attach the manufacturing

order the identifying label

of raw materials and

materials used, when

there was no other

equivalent security

system?

N N NC

4.A.1.11 Are there requirements to

attach the manufacture

order to a final product

label with the lot number

or shipment and

expiration date?

N N NC

4.A.1.12 There is a calculation of

real income obtained at

various stages of

preparation in relation to

the theoretical produce?

N N NC

4.A.1.13 There are appropriate

instructions to pack and

label the product and its

storage conditions?

N N NC


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4.A.1.14 There is a description of

bottles, packaging and

other materials used for

the fractionation, with

codes, quantities and

units of measurement?

N N NC

4.A.1.15 All bottles, production

lines and equipment used

during the production are

clearly identified to

indicate their content or

the stage of lot

processing?

I I NC

4.A.1.16 The equipments, utensils

and packaging materials

are stored or located in

an appropriate place?

N N NC

4.A.2-MANUFACTURING ORDER (Elaboration Register)


4.A.2.1 Is there a true copy

process of the

standard formula to

ensure its accurate

reproduction?

I I NC

4.A.2.2 Contains the product

lot number to be

elaborated?

I I NC


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4.A.2.3 Contains the code

numbers, the lot and

analysis of raw

materials and

materials involved?

I I NC

4.A.2.4 The calculation of raw

materials is in

accordance with the

unit formula or

centesimal?

I I NC

4.A.2.5 It is signed by the

person responsible for

the calculation?

N N NC

4.A.2.6 This signature is

approved by another

person?

N N NC

4.A.2.7 If there is a necessity

to modify the

manufacturing

instructions, the

equipments,

environment and/ or

other conditions, the

modification is

approved by a true

copy authorized

officer?

N N NC

4.A.2.8 Finalized the manufacturing processall the documents on the lot produced (development registration, registration of bottling, labeling, analytical

N N NC


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result of process controls and product

finished) is attached to the Historical Record of Product and archived? For how long? Who is responsible?

4.B-ÁREAS DE PESAGEM E MEDIÇÕES


4.B.1 The area is clean ? N N NC

4.B.2 The materials used for

weights and

measurements are

clean and kept in an

appropriate place?

N N NC

4.B.3 The weighing scales

and measuring tools

are calibrated and

calibrated regularly?

There are records?

N N NC

4.B.4 The receptacles that

contain a raw material

to be weighed or a

measure are cleaned

before they are

opened? Are closed

after the procedure?

N N NC


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4.B.5 The heavy materials

and / or doctors are

properly identified?

I I NC

4.B.6 Appears on the label:

- Name of input;

- Lot number of the

input;

- Product name that is

intended input;

N N NC

Lot number of reagent;

- Amount that was

weighed or a measure;

- Gross weight;

- Signature of person

responsible for

weighing or measure.

4.B.7 The area has

ventilation, lighting,

temperature and

humidity adequate

controls?

N N NC

4.B.8 Has any exhaust

system?

N N NC

4.B.9 The raw materials from

manufacturing lot

already weighed or

measured, are

physically separate

from the another lot

also already weighed?

N N NC

4.B.10 The area has a

separate place for

R R NC


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washing utensils used?

4.B.11 Is there a system for

preventing cross-

contamination during

the weighing or

measurements?

N N NC

4.B.12 Is there any way to

prevent contamination

of the environment

through the exhaust

system or another

adequate system?

N N NC

4.C-PRODUCTIVE AREAS: ELABORATION/ FRACTIONATION


4.C.1 How many square meters

covered are destined for

the production, excluding

the storage area?

INF INF NC

4.C.2 Are there separate areas

and with appropriate

characteristics for the

various production

processes?

I I NC

4.C.3 Are there how many

areas?

INF INF NC

4.C.4 The occupied area is R R NC


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adequate for the volume

of operations?

4.C.5 What is the number of

employees in the sector?

INF INF NC

4.C.6 The areas are clean? R R NC

4.C.7 Is avoid eating, drinking

and smoking in the

productive sectors?

I I NC

4.C.8 The elimination of used

water, leftovers and other

rejects inside and outside

the building and

surrounding area, is done

in a safe and hygienic

way?

N N NC

4.C.9 Are there written rules of

safety and biosafety? Are

accomplished?

I I NC

4.C.10 Employees use

appropriate footwear and

clothing for the tasks

performed?

N N NC

4.C.11 In production areas is

prohibited the access of

people wearing

inappropriate clothing?

N N NC

4.C.12 Os pisos estão

adequados?

N N NC


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4.C.13 Before applying a method

of pest control is verified if

its use does not present a

risk of contamination for

equipments and products?

N N NC

4.C.14 In the productive areas

are made controls: air

pressure, microbiological,

particulate, moisture,

temperature and toxic

substances? Are there

records? Are there safety

measures for employees?

R R NC

4.C.15 The internal circulation

and distribution of the

locations are appropriate?

The lighting, ventilation

and dimensions are

appropriate?

N N NC

4.C.16 Are taken care to

minimize the possibility of

contamination from one

area to another?

N N NC

4.C.17 Is avoided cross-

contamination of a

product with particles or

dust coming from handling

or storage of another

product?

N N NC

4.C.18 The areas are prepared to

provide appropriate

conditions for stability to

components, materials in

N N NC


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process and finished

products?

4.C.19 Is there a properly

physical separation

between the equipments

to avoid mixing or cross

contamination, when

manufacture

simultaneously lots of

different products?

N N NC

4.C.20 Each critical phase of

production presents the

operator and immediate

superior visa?

R R NC

4.C.21 The electrical installations

are in good condition?

N N NC

4.C.22 Are there inactive lines? INF INF NC

4.C.23 The water pipes, steam,

gas, compressed air and

electricity are properly

identified?

N N NC

4.C.24 The drainage systems are

adequate?

N N NC

4.C.25 It has siphoned boxes?

Are disinfected frequently?

INF INF NC

4.C.26 The walls, floors and

ceilings are constructed

with materials easily

washable?

R R NC


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4.C.27 In the case of products of

animal origin there is own

biotherium? If the answer

is yes, check the quality

control.

INF INF NC

4.D- WASHING AREA


4.D.1 Is there a separate place

for washing materials

and elaboration

recipients?

N N NC

4.D.2 The occupied area is

adequate for the volume

of operations?

R R NC

4.D.3 The quantity and

distribution of equipment

is ordered, rational and

appropriate to the

volume of operations?

R R NC

4.D.4 The circulation area is

free of obstacles?

R R NC

4.D.5 The area is clean? N N NC

4.D.6 What type of water used

in feeding the washing

INF INF NC


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machines or for hand

washing?

4.D.7 The drying greenhouses

work perfectly?

N N NC

4.D.8 The recipients are

transferred safely for the

bottling area to avoid

possible contamination?

N N NC

4.E- MOUNTING, PACKAGING AND LABELING


4.E.1 The access to the labels

and instructions for use

is only allowed to

people duly authorized?

N N NC

4.E.2 The labels and use

instructions are

inspected before being

delivered to the

mounting line?

N N NC

4.E.3 The labeling machines

(if exist), and the

mounting line are

checked before they are

used with respect to

non-existence of labels,

packaging or other

elements of previous

N N NC


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products?

4.E.4 The labels and use

instructions before the

process are examined

to verify if refer to the

product being

assembled and that the

labels contain the lot

number and expiration

date?

N N NC

4.E.5 The labels printed with

lot number and

expiration date that

remained after the

ending of mounting are

destroyed?

N N NC

4.E.6 Are kept label registers

and use instructions

received, used,

destroyed and

returned?

I I NC

4.E.7 Are investigated and

recorded all

mismatches between

the number of bottles

labeled, number of

labels received and

used, including losses?

I I NC

4.E.8 The remaining labels

that do not contain lot

number and expiration

date, returned to the

storage area, are

received by a

N N NC


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designated person for

that?

4.E.9 Are properly recorded

the transactions

described above?

N N NC

5-QUALITY CONTROL


5.1 Are there in the company

Quality Control areas? Are

separated from the

production area?

I I I

5.2 How many areas have the

Quality Control? The area

is appropriate for the

volume of operations?

INF INF INF

5.3 Is there a organizational

structure? There is a job

description for each

position?

N N INF

5.4 The Quality Control is

independent of

production?

I I NC

5.5 To whom reports the

responsible for the Quality

INF INF INF


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Control?

5.6 What is the professional

formation of the person

responsible for quality

control?

INF INF INF


employees in the Quality

Control, and what is the

formation of each?

INF INF INF

5.8 In case of the company

does not have its own the

Quality Control lab , there

is (m) contract (s) of

quality control with third

parties? What (which) is

(are) a (s) of company (s)

and what kind of control

(s) is (are) made?

INF INF INF


responsible for approving

or rejecting the finished

products, semi finished

and stored and supplies

provided by third parties?

N N N

5.10 Are there adequate

equipments for the

inspections made?

N N N

5.11 The equipments or

appliances are installed

properly according with

the requirements of the

manufacturer for its

N N N


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correct functioning?

5.12 Is there a program of

preventive maintenance,

measurement and

calibration clearly

defined? Records are

made?

I I I


responsible for approving

or rejecting manufactured

products, semi finished,

finished, filling material

and packaging?

N N N

5.14 Are there written

procedures with detailed

description of sampling,

analysis, approval or

rejection of raw materials,

semi finished products

and packing material?

N N NC

5.15 Are there detailed

descriptions of analytical

procedures and

verification of

specifications, to be

followed for the control of

raw materials, semi

finished products and

packaging material?

N N N

5.16 The analytical procedures

are consulted and

followed for the analysis

execution?

N N N


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5.17 The Quality Control keeps

the record of analysis

made?

N N N

5.18 The statistical sampling is

done by a person trained

in quality control?

N N N

5.19 Are preserved the

samples of raw materials

used?

R NC NC

5.20 It is defined the time and

storage conditions?

R NC NC

5.21 Are preserved the

samples from each lot of

components of the

finished product? In the

case of importers, the

conservation of these

samples are performed in

the origin country,

properly documented?

N N N

5.22 It is defined the time and

storage conditions?

N N N

5.23 Is there a written

procedure detailing the

period of recontrole of

raw materials?

R NC NC

5.24 Are used standards and

reference materials? Are

kept and used in

accordance with

previously established

N N INF


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procedures?

5.25 The Quality Control has

people designated to

inspect the manufacturing

processes?

N N NC

5.26 The Quality Control

checks all the process

documentation of each

product to certify the

correct implementation,

as well as the proper

investigation and solution

of any non-compliance of

the process?

N N NC

5.27 The Quality Control

verifies that elaborated

each lot is in accordance

with the specifications laid

down before the release?

Are there records?

N N NC

5.28 Microbiological tests are

conducted in appropriate

areas?

N N N

5.29 Biological tests are

performed in appropriate

areas?

N N N

5.30 Is there a biotherium? It

is located outside the

building? If has inside the

building, the ventilation

systems

and air conditioning are

I I NC


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well separated from any

other system?

5.31 There are rules and

records of environmental

conditions, hygiene,

accommodation, food and

animal health in the

animal bioterium?

N N NC

5.32 The bioterium is clean?

Frequency of cleaning.

N N NC

5.33 There are areas of animal

experimentation? Are

separate from the

biotherium?

R R NC

5.34 Is there separation of

animals previously

subjected to tests, those

that are being submitted

for testing, and those who

have not yet been

submitted? Controls are in

place to release animals

from quarantine? Are

there records?

N N NC

5.35 The test animals are

being identified? How?

N N NC

5.36 Is there record of the

history and use of animals

subjected to tests?

N N NC

5.37 Are the norms of N N N


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biosafety obey?

6-QUALITY CONTROL


6.1 The company has a quality

assurance program?

N N N

6.2 Are there written standards

for publicizing and

compliance for the good

manufacturing practices at

all levels?

N N NC

6.3 Is there in the company an

area that coordinates the

activities of quality

assurance?

N N N

6.4 Are clearly defined the

responsibilities for quality

management?

N N N

6.5 Are there written

procedures or systems to

evaluate the efficiency and

application of the rules and

N N N


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the quality system?

6.6 There is a program of staff

training? Are there training

records of each employee?

N N N

6.7 The products are developed

and designed in accordance

with the requirements of

good manufacturing

practices?

N N NC

6.8 The new knowledge

acquired in the processes

and the modifications are

implemented only after in

the thorough evaluation

and approval?

R R NC

6.9 The internal audits are

conducted to verify the

compliance of the good

manufacturing practices? Is

there register?

R R NC

6.10 Is there a written program of study of the stability of the products, with test conditions, record results, analytical methods used, storage conditions of samples, bottling primary, frequency of analysis and expiration date

N N NC

Is there a written program of study of the stability of the products, test, record results, analytical methods used, storage conditions of samples, bottling primary frequency of analysis and expiration date?


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6.11 Records are made of

complaints received about

the quality of the products

or any modification of their

physical characteristics as

well as decisions taken?

N N N

7-MINUTE OF AUDIT

7.1 Company name .

7.2 Auditors name.

7.3 Reason for audit and audit order number.

7.4 Name, position and professional formation of the people interviewed.

7.5 Were collected samples of products? What? How many? Specifications of

the samples collected.

7.6 Description of observations made during the audit. Description of

operational procedures.

7.7 The period recommended by the auditor of the Secretary of Health

Surveillance to implement the corrective actions when applicable?

7.8 Comments on the observations of the auditor by the company responsible

for.

7.9 Closing the audit and the minute, with an original and sufficient copies,

being one of it to the company.


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brazil-rdc-no-167-2-july-2004

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Transcript of brazil-rdc-no-167-2-july-2004