Brazil RDC No 167 2 July 2004

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.
RESOLUTION - RDC N 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
5045-0910
EMERGO SOUTH AMERICA LTDA. SIBS Qd. 02 | Cj. B, Lt. 13/14 | Braslia DF 71.736-202 | Brasil | Telefone: +55.61.3386.3166
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
Whats the company Tax ID Number?
INF
INF
INF
1.2
For whom the auditors are assisted?
1.3
The responsible Technical Director is present?
1.4
There is proof of inscription of company's Technical Director and the Board of Health competent?
1.5
The
company of authority
has the for
authorization competent location, protection safety?
operation with regard to environmental and plant
5045-0910
1.6
The plants of the buildings were presented?
1.7
What
is
the
number by
of the
INF
INF
INF
employees company?
hired
1.8
What linked
is
the
number to
of the
INF
INF
INF
employees who are directly administrative, sales and production Company? area of the
1.9
Was presented the list of products that are on sale or not?
1.10
All these products are duly registered at the Ministry of Health?
1.11
The area occupied by the company is appropriate for the declared capacity?
INF
INF
INF
1.12
What's
own
production by the
NC
capacity of each product manufactured company?
1.13
There
are
manufacturing with third
INF
INF
INF
contracts parties?
What are the names of the contractors?
5045-0910
1.14
Imports finished
raw
materials, bulk,
INF
INF
INF
product,
semi-finished?
1.15
Export product,
supplies, bulk,
finished semi-
INF
INF
INF
finished?
1.A- EXTERNAL CONDITIONS
Manufacturer
Fractionator
Importer
1.A.1
On the external side, the good (no buildings cracks, have peeling conservation?
paint, leaks, etc?
1.A.2
Is
there
protection
against the entry of rodents, insects, birds or other animals?
1.A.3
The conservation structure,
physical of the and
conditions and state of walls
roofs are appropriate?
1.A.4
The access roads are adequate?
5045-0910
1.B- INTERNAL CONDITIONS
Manufacturer
Fractionator
Importer
1.B.1
The state of hygiene and maintenance (no holes and cracks, no breaks,) appropriate? is
1.B.2
The
walls
are
well
preserved?
1.B.3
The state of hygiene is adequate?
1.B.4
The
ceilings
are
appropriate and are in good condition?
1.B.5
The
sewers
and
plumbing are in good condition?
1.B.6
Is
the
lighting
adequate?
1.B.7
The installations good
electrical are in safe condition,
5045-0910
and proper use?
1.B.8
Have
been of
noted rodents,
INF
INF
INF
evidence animals?
insects, birds or other
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.
conducted frequency?
by
contractor, what is the
1.B.10
There
is
safety
equipment for fighting fires? Access to fire extinguishers hoses available? will and be
1.B.11
There is a permanent health care plan and emergency in case of response sudden
INF
INF
INF
illness or accident at work?
1.B.12
There toilets?
are
sufficient the
INF
INF
INF
Check
cleanliness of them.
5045-0910
1.B.13
There rooms
are in
changing sufficient Check the
INF
INF
INF
quantity?
cleanliness of them.
1.B.14
The
staff
uses
the
INF
uniform
appropriate?
Check the conditions of cleaning them.
1.B.15
Is there a restaurant? If not, where the employees eat?
INF
INF
INF
1.B.16
There water
are in
water sufficient and
INF
INF
INF
fountains for drinking quantities
appropriate places?
1.B.17
There and
are
identified appropriate for of waste? cleaned
INF
INF
INF
containers collection They are frequently?
2- STORAGE AREA
Manufacturer
Fractionator
Importer
2.1
The room temperature is in line with the conditions of storage of raw
5045-0910
materials, finished products?
bulk, and
semi finished
2.2
The is
storage controlled
area ?
temperature and humidity Check the records at the time of the audit.
2.3
There
is
need
for
cold
INF
INF
INF
storage?
2.4
Having
cold
room,
its
temperature is controlled and recorded?
2.5
What is the temperature at the time of the audit?
2.6
How often are calibrated the weighing scales? Check the records.
NC
2.7
The storage disposition is rational order to and correct in the preserve
integrity and the identity of the material?
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?
5045-0910
2.9
There are guarantees of separation materials, of packaging semi materials, packaging, raw bulk, finished and the product manufactured?
2.10
There is in a storage area a quarantine system?
2.11
There is in a storage area a system identification of rejected products?
2.12
There is in a storage area an identification system for storing of tags, labels and instruction manuals?
2.13
Explosive and flammable products are stored in an appropriate place?
2.14
It
is
approved
by
the
competent authority?
2.15
There is in the storage area, separate locations, closed by key and with access narcotic psychotropic, restricted toxic to or substances,
similars when needed?
2.16
There are signs and verbal communication about the characteristics of radioactivity, the risk of
5045-0910
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 system an identification visual
NC
examination of materials at the reception to check if they were damaged during transportation?
2.A.2
Is there a way to prove that cold was followed the during chain
NC
transportation?
2.A.3
The
reception
of
the
NC
material is documented?
2.A.4
At
each for
material each lot
NC
entrance, is registered a number received?
2.A.5
Before Quality
the
release remain
by the in
NC
Control,
materials
5045-0910
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?
NC
2.A.7
Are obtained samples of materials control with in for quality and accordance
NC
appropriate
reliable systems?
2.A.8
The
supplies as
are such and to storage
NC
identified approved transferred appropriate location?
2.A.9
The expiry date and date of review are indicated on the label?
NC
2.A.10
The are
rejected properly
products identified
NC
and segregated?
2.A.11
The available storage is rational and correct in order to preserve the identity and integrity of the supplies?
NC
2.A.12
Which system is used for stock control? Is it
NC
5045-0910
functional?
2.A.13
The packaging (drums, barrels, which materials closed? identified? boxes contain are Are etc.). the well properly
NC
2.B- RECEPTION AND STORAGE OF FINISHED PRODUCTS
Manufacturer
Fractionator
Importer
2.B.1
There is a entry system of registering and stock control product? of the finished
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?
2.B.3
The storage of finished product, is realized with due order and safety, possible avoiding
confusion in the control and shipping as well as
5045-0910
handling accidents?
2.B.4
The available storage is rational order to and correct in the preserve
identity and integrity of the finished products?
2.B.5
The expired products are removed warehouse destroyed reprocessed, procedure registered? is from and and and / the later or this
properly
2.B.6
What of the
is
the
company close of to the
policy regarding the sale products expiration date? Verify
compliance
policy and the existence of records.
2.B.7
Inventories conducted Are records of that?
are periodically?
INF
INF
INF
2.C- DEVOLUTIONS
Fabricante
Fracionador
Importador
2.C.1
There is an area that limits or restricts the storage of
5045-0910
returned products?
2.C.2
These
products
are
identified as such?
2.C.3
Are there responsables for the decision making for its due treatment?
2.C.4
The occur?
quality
control
is
informed about the returns
2.C.5
Are recorded the analysis realized, results and decisions taken?
2.C.6
After
analysis
of
the
material, is processed its destruction or reprocessing as provided in procedures? There are corresponding records?
2.C.7
Os anexados
registros ao
do Registro
procedimento anterior so Histrico do Produto?
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.
5045-0910
Manufacturer
Fractionator
Importer
2.D.1
There
is
a of
control finished
distribution distributors.
products Check the list of
2.D.2
The company establishes and procedures maintains for the
products removal?
2.D.3
Establishes ensuring application procedures? the of
and correct these
maintains a system that
2.D.4
There
is
designated for of the and the product
responsible coordination execution procedure removal? for
2.D.5
If the person responsible for performing this task does not belong to the Quality Department, of the Control this operations
department is informed performed?
2.D.6
There are records of the information of the products market removal
5045-0910
, as well as its causes?
2.D.7
In
case
of
market for the are
products
removal
non-compliance, other countries
competent authorities of reported immediately?
2.D.8
Immediate taken to
steps remove
are the
product throughout the territory in which it was distributed? There is registration?
2.D.9
The records of product distribution primary at level the are
available for quick action from the market?
2.D.10
These
records that
contain allows and resulting primary
information traceability the from
identification of what are receivers the
distribution?
2.D.11
There storage
is
a of
safe area from
and for the
appropriate removed
products
market, and are properly identified, while waiting its destination?
5045-0910
2.D.12
Existem registros sobre o destino dos produtos retirados do mercado ?
3- SYSTEM AND WATER INSTALLATIONS
Manufacturer
Fractionator
Importer
3.1
The company uses water, sterile? purified, distilled, distilled or
INF
INF
INF
3.A- POTABLE WATER
Manufacturer
Fractionator
Importer
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
5045-0910
before
the
water
is
stored? What?
3.A.4
It made the cleaning of the water tanks? How often? There are records?
INF
3.A.5
They are made physicalchemical controls? Which ones? How often? There are records?
INF
3.A.6
Microbiological How often?
controls There are
INF
are made? Which ones? records?
3.A.7
Water sample is collected from the different company, parts of including control?
INF
the fountains, to make a microbiological There are records?
3.A.8
The in
piping good
used
to of and
INF
transport clean water is condition cleaning conservation?
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?
5045-0910
3.B.1- DEIONIZATION
Manufacturer
Fractionator
Importer
3.B.1.1
The
industry of
has purified is the
INF
INF
NC
deionizer equipment for production water? It is What
capacity in liters / hour? preventive made in maintenance
the system equipment ? There are records?
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?
NC
3.B.1.4
The
resins
are
NC
regenerated frequently? There are records?
3.B.1.5
The water that supplies the deionizer is treated? How?
INF
INF
NC
3.B.1.6
If
the
water is
that a
NC
supplies the chlorinated deionizer chlorine there system to remove the before
5045-0910
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 the consumption? prevent microbial average contamination? What is
NC
3.B.1.8
Physical controls are
chemical made?
NC
What? How often? There are records?
3.B.1.9
chemical made?
NC
3.B.1.10
The
transportation
or
NC
movement of deionized water is done through proper piping?
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?
NC
3.B.1.13
The purification system is validated? There are
NC
5045-0910
records?
3.B.2- REVERSE OSMOSIS
Manufacturer
Fractionator
Importer
3.B.2.1
The reverse
industry
has osmosis for
INF
INF
NC
equipment production water? the records? It of
purified
preventive system
maintenance is made in equipaments? There are
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 the system? operation
INF
INF
NC
responsable is present?
3.B.2.5
There is an operation manual for the system? It is used?
NC
3.B.2.6
There is a deposit for this water? What is the
NC
5045-0910
capacity? What is the material used? Is there any treatment to avoid microbial contamination? What is the consumption? average
3.B.2.7
chemical made?
NC
3.B.2.8
chemical made?
NC
3.B.2.9
The done
transportation through
or the
NC
movement of water is properly pipe?
3.B.2.10
The water produced is used as raw material for liquid products?
INF
INF
NC
3.B.2.11
NC
3.B.2.12
The purification system is valid? There are records?
NC
5045-0910
3. C- DISTILLED WATER / BIDISTILLED
Manufacturer
Fractionator
Importer
3.C.1
The produce water? the records?
industry this It kind
has of
INF
INF
NC
distillation equipment to preventive system
maintenance is made in equipaments? There are
3.C.2
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
NC
3.C.6
There is a deposit for this water? What is the capacity? What is the
NC
5045-0910
material used? Is there any treatment to avoid microbial contamination? What is the average consumption?
3.C.7
chemical made?
NC
3.C.8
chemical made?
NC
3.C.9
The done
transportation through
or the
NC
movement of water is properly pipe?
3.C.10
The water produced is used as raw material for liquids quality? and to control
INF
INF
NC
3.C.11
NC
3.C.12
The purification system is valid? There are records?
NC
5045-0910
3.D-STERILE WATER
Manufacturer
Fractionator
Importer
3.D.1
The
industry
has
INF
INF
NC
sterilization equipment for the production of sterile water? in It the are preventive maintenance made? records? system equipment is There
3.D.2
INF
INF
NC
3.D.3
The
water
that
INF
INF
NC
supplies the sterilizer is treated? How?
3.D.4
There is trained staff to operate the system? The the responsable operation for is
INF
INF
NC
present?
3.D.5
NC
5045-0910
3.D.6
Sterility made? often? records?
controls What? There
are How are
NC
3.D.7
Water is released by Quality Control before being used?
NC
3.D.8
The
purification
NC
system is valid? There are records?
4-PRODUCTION
Manufacturer
Fractionator
Importer
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 The
of technical staff
staff and is
INF
INF
NC
employed in the area. specialized enough?
4.5
There is a training plan for the staff?
NC
5045-0910
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?
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
Manufacturer
Fractionator
Importer
4.A.1.1
Is
there
standard
NC
formula for each product manufactured?
4.A.1.2
This standard formula is prepared, reviewed and approved by responsible people and countersigned by another responsible?
NC
4.A.1.3
There proceed
are on when
written how to is
NC
procedures
5045-0910
necessary to modify the standard formula?
4.A.1.4
The
standard
formula
NC
contains: - Name, code or product catalog number or of each component?
Composition of
of
each or
component of the product period stability, temperature? - Quantity theory of the product to be manufactured? validity storage
4.A.1.5
There
are
detailed
NC
instructions for all stages of manufacture, place of production and equipments to be used?
4.A.1.6
There is a equipaments cleaning procedure?
NC
4.A.1.7
There is one responsible for verifying the execution of the cleaning equipment used?
NC
4.A.1.8
There detailed steps
are
clear
and
instructions require of the
identifying the elaboration that intervention quality
control for process control

5045-0910
and identification of the person date? responsible and
4.A.1.9
There are requirements to attach records pressure when the manufacture order, registers, graphic of temperature, and the humidity procedure
requires control of them?
4.A.1.10
Are there requirements to attach the manufacturing order the identifying label of raw materials used, no was and when other security materials there system? equivalent
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?
NC
4.A.1.12
There is a calculation of real income obtained at various stages of preparation in relation to the theoretical produce?
NC
4.A.1.13
There
are
appropriate
NC
instructions to pack and label the product and its storage conditions?
5045-0910
4.A.1.14
There is a description of bottles, the packaging and with and other materials used for fractionation, quantities codes,
NC
units of measurement?
4.A.1.15
All
bottles,
production
NC
lines and equipment used during the production are clearly the identified stage of to lot indicate their content or processing?
4.A.1.16
The equipments, utensils and packaging materials are stored or located in an appropriate place?
NC
4.A.2-MANUFACTURING ORDER (Elaboration Register)
Manufacturer
Fractionator
Importer
4.A.2.1
Is there a true copy process standard ensure its of formula the to accurate
NC
reproduction?
4.A.2.2
Contains the product lot number to be elaborated?
NC
5045-0910
4.A.2.3
Contains analysis materials
the of
code raw and
NC
numbers, the lot and
materials involved?
4.A.2.4
The calculation of raw materials accordance unit centesimal? is with in the or
NC
formula
4.A.2.5
It
is
signed
by
the
NC
person responsible for the calculation?
4.A.2.6
This person?
signature
is
NC
approved by another
4.A.2.7
If there is a necessity to modify the the and/ or the is a true authorized manufacturing instructions, equipments, environment other modification approved copy officer? Finalized the manufacturing processall the documents on the lot produced (development registration, registration of bottling, labeling, analytical by conditions,
NC
4.A.2.8
NC
5045-0910
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-REAS DE PESAGEM E MEDIES
Manufacturer
Fractionator
Importer
4.B.1
The area is clean ?
NC
4.B.2
The materials used for weights measurements appropriate place? and are
NC
clean and kept in an
4.B.3
The and are
weighing measuring calibrated
scales tools and
NC
calibrated
regularly?
There are records?
4.B.4
The
receptacles
that
NC
contain a raw material to be weighed or a measure are cleaned before opened? they Are are closed
after the procedure?
5045-0910
4.B.5
The
heavy
materials
NC
and / or doctors are properly identified?
4.B.6
Appears on the label: Name of input; - Lot number of the input; - Product name that is intended input;
NC
Lot number of reagent; Amount Gross that was weighed or a measure; weight; for - Signature of person responsible weighing or measure.
4.B.7
The
area
has lighting, and adequate
NC
ventilation, temperature humidity controls?
4.B.8
Has
any
exhaust
NC
system?
4.B.9
The raw materials from manufacturing already physically weighed measured, lot or are separate
NC
from the another lot also already weighed?
4.B.10
The
area
has place
a for
NC
separate
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washing utensils used?
4.B.11
Is there a system for preventing contamination the weighing measurements? crossduring or
NC
4.B.12
Is there any way to prevent contamination of the environment the or exhaust another through system
NC
adequate system?
4.C-PRODUCTIVE AREAS: ELABORATION/ FRACTIONATION
Manufacturer
Fractionator
Importer
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 various processes? with appropriate for the production characteristics
NC
4.C.3
Are
there
how
many
INF
INF
NC
areas?
4.C.4
The
occupied
area
is
NC
5045-0910
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?
NC
4.C.7
Is avoid eating, drinking and smoking in the productive sectors?
NC
4.C.8
The elimination of used water, leftovers and other rejects inside and outside the in a way? building safe and and hygienic surrounding area, is done
NC
4.C.9
Are there written rules of safety and biosafety? Are accomplished?
NC
4.C.10
Employees clothing for the
use tasks
NC
appropriate footwear and performed?
4.C.11
In
production
areas
is
NC
prohibited the access of people wearing inappropriate clothing?
4.C.12
Os
pisos
esto
NC
adequados?
5045-0910
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?
NC
4.C.14
In the productive areas are made controls: air pressure, particulate, temperature substances? microbiological, moisture, and Are toxic there
NC
records? Are there safety measures for employees?
4.C.15
The and The and
internal
circulation of the
NC
distribution lighting,
locations are appropriate? ventilation are dimensions
appropriate?
4.C.16
Are
taken
care from
to one
NC
minimize the possibility of contamination area to another?
4.C.17
Is
avoided
crossof a
NC
contamination
product with particles or dust coming from handling or storage of another product?
4.C.18
The areas are prepared to provide appropriate conditions for stability to components, materials in
NC
5045-0910
process products?
and
finished
4.C.19
Is
there
properly separation
NC
physical
between the equipments to avoid mixing or cross contamination, manufacture simultaneously lots of different products? when
4.C.20
Each
critical
phase
of the
NC
production operator
presents
and immediate
superior visa?
4.C.21
The electrical installations are in good condition?
NC
4.C.22
Are there inactive lines?
INF
INF
NC
4.C.23
The water pipes, steam, gas, compressed air and electricity identified? are properly
NC
4.C.24
The drainage systems are adequate?
NC
4.C.25
It
has
siphoned
boxes?
INF
INF
NC
Are disinfected frequently?
4.C.26
The with
walls, are
floors
and easily
NC
ceilings
constructed
materials
washable?
5045-0910
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
Manufacturer
Fractionator
Importer
4.D.1
Is there a separate place for and recipients? washing materials elaboration
NC
4.D.2
The
occupied
area
is
NC
adequate for the volume of operations?
4.D.3
The
quantity
and
NC
distribution of equipment is ordered, rational and appropriate to the volume of operations?
4.D.4
The circulation area is free of obstacles?
NC
4.D.5
The area is clean?
NC
4.D.6
What type of water used in feeding the washing
INF
INF
NC
5045-0910
machines washing?
or
for
hand
4.D.7
The drying greenhouses work perfectly?
NC
4.D.8
The
recipients
are
NC
transferred safely for the bottling area to avoid possible contamination?
4.E-
MOUNTING, PACKAGING AND LABELING
Manufacturer
Fractionator
Importer
4.E.1
The access to the labels and instructions for use is only allowed to people duly authorized?
NC
4.E.2
The
labels
and
use are
NC
instructions delivered to
inspected before being the mounting line?
4.E.3
The labeling machines (if exist), and line respect or of the are to mounting used with
NC
checked before they are non-existence of labels, packaging elements other previous
5045-0910
products?
4.E.4
The
labels
and
use
NC
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?
4.E.5
The labels printed with lot number date after and that the expiration remained destroyed?
NC
ending of mounting are
4.E.6
Are kept label registers and use instructions used, and received, destroyed returned?
NC
4.E.7
Are
investigated
and all
NC
recorded mismatches labeled, labels
between of and
the number of bottles number received
used, including losses?
4.E.8
The
remaining
labels
NC
that do not contain lot number and expiration date, returned to the storage received area, by are a
5045-0910
designated that?
person for
4.E.9
Are properly recorded the transactions described above?
NC
5-QUALITY CONTROL
Manufacturer
Fractionator
Importer
5.1
Are there in the company Quality Control areas? Are separated from the production area?
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 position? for each
INF
5.4
The
Quality
Control
is of
NC
independent production?
5.5
To
whom
reports
the
INF
INF
INF
responsible for the Quality
5045-0910
Control?
5.6
What is the professional formation of the person responsible control? for quality
INF
INF
INF
5.7
What is the number of 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
5.9
The
Quality
Control
is
responsible for approving or rejecting the finished products, semi finished and stored and supplies provided by third parties?
5.10
Are
there
adequate for the
equipments
inspections made?
5.11
The
equipments are according for
or with its
appliances properly
installed
the requirements of the manufacturer
5045-0910
correct functioning?
5.12
Is there a program of preventive calibration defined? made? Records maintenance, and clearly are measurement
5.13
The
Quality
Control
is
responsible for approving or rejecting manufactured products, finished, semi filling finished, material
and packaging?
5.14
Are
there of
written sampling, or
NC
procedures with detailed description analysis, semi approval
rejection of raw materials, finished products and packing material?
5.15
Are
there
detailed and of to be semi and
descriptions of analytical procedures verification specifications, raw finished materials, products
followed for the control of
packaging material?
5.16
The analytical procedures are consulted and followed for the analysis execution?
5045-0910
5.17
The Quality Control keeps the record of analysis made?
5.18
The statistical sampling is done by a person trained in quality control?
5.19
Are used?
preserved
the
NC
NC
samples of raw materials
5.20
It is defined the time and storage conditions?
NC
NC
5.21
Are
preserved of
the the the
samples from each lot of components case of finished product? In the importers, of conservation the origin these country,
samples are performed in properly documented?
5.22
It is defined the time and storage conditions?
5.23
Is
there of
written the of
NC
NC
procedure period
detailing recontrole
raw materials?
5.24
Are used standards and reference materials? Are kept and used in with established accordance previously
INF
5045-0910
procedures?
5.25
The Quality Control has people designated to inspect the manufacturing processes?
NC
5.26
The checks product correct as
Quality all to as the
Control process of each the
NC
documentation
certify the
implementation, proper
well
investigation and solution of any non-compliance of the process?
5.27
The verifies
Quality that
Control elaborated
NC
each lot is in accordance with the specifications laid down before the release? Are there records?
5.28
Microbiological tests are conducted in appropriate areas?
5.29
Biological areas?
tests
are
performed in appropriate
5.30
Is there a biotherium? It is located outside the building? If has inside the building, systems and air conditioning are the ventilation
NC
5045-0910
well separated from any other system?
5.31
There
are
rules
and
NC
records of environmental conditions, animal health hygiene, in the accommodation, food and animal bioterium?
5.32
The bioterium is clean? Frequency of cleaning.
NC
5.33
There are areas of animal experimentation? separate biotherium? from Are the
NC
5.34
Is
there
separation
of
NC
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?
5.35
The
test
animals
are
NC
being identified? How?
5.36
Is
there
record
of the
NC
history and use of animals subjected to tests?
5.37
Are
the
norms
of
5045-0910
biosafety obey?
6-QUALITY CONTROL
Manufacturer
Fractionator
Importer
6.1
The company has a quality assurance program?
6.2
Are there written standards for publicizing and compliance for the good manufacturing practices at all levels?
NC
6.3
Is there in the company an area that coordinates the activities assurance? of quality
6.4
Are
clearly
defined
the
responsibilities for quality management?
6.5
Are
there
written
procedures or systems to evaluate the efficiency and application of the rules and
5045-0910
the quality system?
6.6
There is a program of staff training? Are there training records of each employee?
6.7
The products are developed and designed in accordance with the requirements of good practices? manufacturing
NC
6.8
The
new
knowledge
NC
acquired in the processes and the modifications are implemented only after in the thorough evaluation and approval?
6.9
The
internal to of
audits verify the
are the good
NC
conducted compliance
manufacturing practices? Is there register? 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 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?
5045-0910
6.10
NC
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?
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.
5045-0910
5045-0910

Brazil RDC No 167 2 July 2004

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Brazil RDC No 167 2 July 2004

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

RESOLUTION - RDC N 167, JULY, 02, 2004.

CLAUDIO MAIEROVITCH PESSANHA HENRIQUES

Whats the company Tax ID Number?

For whom the auditors are assisted?

The responsible Technical Director is present?

has the for

authorization competent location, protection safety?

operation with regard to environmental and plant

The plants of the buildings were presented?

Was presented the list of products that are on sale or not?

All these products are duly registered at the Ministry of Health?

capacity of each product manufactured company?

manufacturing with third

What are the names of the contractors?

1.A- EXTERNAL CONDITIONS

paint, leaks, etc?

against the entry of rodents, insects, birds or other animals?

The conservation structure,

physical of the and

conditions and state of walls

roofs are appropriate?

The access roads are adequate?

1.B- INTERNAL CONDITIONS

The state of hygiene is adequate?

appropriate and are in good condition?

plumbing are in good condition?

The installations good

electrical are in safe condition,

and proper use?

insects, birds or other

contractor, what is the

illness or accident at work?

changing sufficient Check the

Check the conditions of cleaning them.

Is there a restaurant? If not, where the employees eat?

water sufficient and

fountains for drinking quantities

identified appropriate for of waste? cleaned

containers collection They are frequently?

The room temperature is in line with the conditions of storage of raw

materials, finished products?

temperature is controlled and recorded?

What is the temperature at the time of the audit?

The storage disposition is rational order to and correct in the preserve

integrity and the identity of the material?

There is in a storage area a quarantine system?

There is in a storage area a system identification of rejected products?

Explosive and flammable products are stored in an appropriate place?

similars when needed?

2.A - RECEIVING AND STORAGE OF SUPPLIES

It's made in a storage area system an identification visual

material each lot

entrance, is registered a number received?

labeled and separated?

are such and to storage

identified approved transferred appropriate location?

Which system is used for stock control? Is it

2.B- RECEPTION AND STORAGE OF FINISHED PRODUCTS

confusion in the control and shipping as well as

The available storage is rational order to and correct in the preserve

identity and integrity of the finished products?