Ministry of Health & Medical
Education
Food and Cosmetic Control
Affairs
Self assessment checklist for GMP
In Cosmetic &Hygienic manufacturers
Code of document:GMP/F-003
Date of Issue: 10/2007
Review: 00
Review date:00
Page 1 of 19
GMP Self Assessment Report
of cosmetic &hygienic foreign manufacturers for importing their
products to IRAN
Scope of assessment:……………..
Name ofAssessors:………
Country:………………..
Date:……….
Score%:…………
Ministry of Health & Medical
Education
Food and Cosmetic Control
Affairs
Self assessment checklist for GMP
In Cosmetic &Hygienic manufacturers
History and Generals:
1) Name of factory:
2) Factories complete address:
3) Factory's foundation date: (Complete Details)
4) Factories zone:
Industrial zone o
Residential zone o
Out of city o
5) Telephone / Fax Number/ Web Page/ Mail Box:
6)If the factory have any branches ?(name of the branches and their countries)
7)Name of Distributer(Company)in IRAN and It’s Specifications:
8)Group of products: pharmaceutical ( ) hygiene &cosmetics ( ) veterinary ( ) food( )
Code of document:GMP/F-003
Date of Issue: 10/2007
Review: 00
Review date:00
Page 2 of 19
Ministry of Health & Medical
Education
Food and Cosmetic Control
Affairs
Self assessment checklist for GMP
In Cosmetic &Hygienic manufacturers
Code of document:GMP/F-003
Date of Issue: 10/2007
Review: 00
Review date:00
Page 3 of 19
9) Production group:
Raw material:
Finish products:
Cosmetics o
Cosmetics 0
Hygienic o
Hygienic 0
packaged o
Packaged 0
10)Type of products manufactured and their brands :
11) Personnel qualification,experience&responsibilities of key Quality personnel:
12) If it maintains any exclusive agency or sales department in IRAN?(which companies)
13) If it maintains any establishments in other countries?
Yes 0 No 0
(Mentioning the names of the countries)
14) If the factory is the main producer? 0
OR
Operates under any license? 0
15)If the company produce private label products?
16) Are the produced raw material and/or finished products used by the internal market? Yes o No o
17) To which countries are the finished products exported? (Names of companies and countries, if possible, presenting the
documents for inspection)
Ministry of Health & Medical
Education
Food and Cosmetic Control
Affairs
Code of document:GMP/F-003
Date of Issue: 10/2007
Review: 00
Review date:00
Page 4 of 19
Self assessment checklist for GMP
In Cosmetic &Hygienic manufacturers
18)Submitting the name and the country of the raw material suppliers of the factory ?
19) Does the Company maintain a P.M.S system?(complete details) Yes 0
No o
(P.M.S: Post Marketing Surveillance)
20) Brief description of complaints handling procedures and self inspection procedures? (Documents attached )
21)Brief description of Recall procedures?
22)If there are any certificates or approvals such as GMP, ISO,FDA approve,…..
23) Attach Flow diagram of manufacturing process of products ?
24)Type of equipments in production section? ( Number,volume and quality of reactors and tanks in the production
line and their location in this section (Flow Chart shall be drawn):
25)Main equipments in QC?(physico-chemical&microbial)
26)If it is necessary, sampling of the finished products carriesout?
Ministry of Health & Medical
Education
Food and Cosmetic Control
Affairs
Self assessment checklist for GMP
In Cosmetic &Hygienic manufacturers
Code of document:GMP/F-003
Date of Issue: 10/2007
Review: 00
Review date:00
Page 5 of 19
( IF THE COMPANY PACKAGED ONLY BULK PRODUCT )
1)From which one of the companies the bulk produt is purchased?
2)What is the type of bulk product?
3)If the producer of bulk product has the credible GMP certificate?(to be annexed)
4)If there is a certificate of analysis that is issued by producing company with the name and degree of the ingredients and
physico- chemical and microbial specifications?(to be annexed)
5)If the packing company performs tests for product series before packaging?(if the answer is yes, explain completely)
6)If the bulk product is prepared from other countries, is there any govermental organisations confirm importing of
mentioned product?
7)What is the appropriate conditions for storing and transporting of bulk product?
General manager confirmation
Name&signature
QC or QA confirmation
Name&signature
Ministry of Health & Medical
Education
Food and Cosmetic Control
Affairs
Self assessment checklist for GMP
In Cosmetic &Hygienic manufacturers
Code of document:GMP/F-003
Date of Issue: 10/2007
Review: 00
Review date:00
Page 6 of 19
Name of manufacturer:
Address:
Auditing
Site
Auditing Case
Results
Yes
Principles of foundation:
1) Are the allocated premises quite enough for accommodation of the equipment?
2) Are there the possibilities of protection, maintenance and cleaning of
installations?
3) If the hygienic and dressing rooms are located in an appropriate place to the
Production and packaging salons?
4) If the surfaces of walls and floors are non-penetrable, have proper quality, are
even and washable?
5) If the floors are free of any cracks and leaks with proper steep towards the sewage?
6) If the factory maintains any industrial sewage system?
7) If the location of sewage discharge system is appropriate? (If possible)
(Sewage discharge system has to be far from Production room)
8) If the windows and doors have properly been designed and produced?
(The windows maintain screens, smooth-edged and, steep)
9) If the ceilings are designed and produced properly?
(Proper height, cleaning possibility and ...)
10) Which one of the following methods is used in providing water being applied in
production and cleaning lines? Is it appropriate? Cationic resin o Anion Resin o
Cationic and anionic Resin 0
reverse osmosis system o
U.V. unit o
Coloration unit o
and other methods
11) If cables and pipes have properly been installed?
(In specific canals and directions under proper condition)
12) If surrounding &yards has been established in a proper location?
Quality control confirmation:
Name and signature:
Date of confirmation :
NO
Notice
Ministry of Health & Medical
Education
Food and Cosmetic Control
Affairs
Auditing
Site
Self assessment checklist for GMP
In Cosmetic &Hygienic manufacturers
Code of document:GMP/F-003
Date of Issue: 10/2007
Review: 00
Review date:00
Page 7 of 19
Auditing Case
Results
Principles of
foundation
Yes
NO
Yes
NO
Notice
13) If the steam system is appropriate?
14) If there is installed any natural and mechanical ventilation system to decrease Air
pollution and control the environmental temperature?(storages-manufacturinglaboratories)
15) Having screen or wire mesh with suitable and cleanable material for ventilator or
trap door?
16) If there is enough natural and artificial lights system?
17) If the factory is equipped with proper heating and cooling system?
Production Section:
1) If the Space of production section is appropriate?
2) If the quality of the tanks and production reactors as well as transfer and
reservation are appropriate? (attached the documents)
3) If the quality of the connecting pipes is appropriate between the tanks and
reactors?
4)If transfer method of material from the tanks and reactors to the packing saloon is
continues?(If the answer is negative describe it)
5) If the machineries and equipment available in the production section maintain any
"machineries condition card"?
Auditing
Site
Auditing Case
Results
Prod
uctio
n
Secti
6) If the factory maintains any modern executive instructions (SOP) to work with the
units and machineries?
Quality control confirmation:
Name and signature:
Date of confirmation :
Notice
Ministry of Health & Medical
Education
Food and Cosmetic Control
Affairs
Self assessment checklist for GMP
In Cosmetic &Hygienic manufacturers
Code of document:GMP/F-003
Date of Issue: 10/2007
Review: 00
Review date:00
Page 8 of 19
(SOP: Standard Operating Procedure)
7) If there have been established cleaning and disinfection systems (SSOP) for
production salon and equipment, if yes, are they carried out?(attach it)
(SSOP: Sanitary Standard Operation Procedure)
8) If In process control is executed on production?
(Weight, pressure, presence of suspended particles and ...,( in which intervals and by
which method)
9) If the worker’s cloths of the production site are appropriate?
((Uniform, mask, gloves,)
10) If frequentation of the personnel to the production section is well arranged?
11) If the production section is equipped with a computer system to control the
production processes? (Complete description)
12) Are the raw material which confirmed by laboratory use in production line?
13) If all openings, holes, or pipe entries through the outside walls, properly sealed or
screened?
14) If there have adequate dust control where necessary?
15) If the production tools and equipment are calibrated on time and according to the
scheduled plan? (Attach documents)
16) If laboratory tools and equipment are calibrated on time and according to the
scheduled plan on production?
Auditing
Site
Auditing Case
Results
Yes
Pr
od
uc
tio
17) If bulk storage tanks clean, undamaged and suitable for use?
Quality control confirmation:
Name and signature:
Date of confirmation :
NO
Notice
Ministry of Health & Medical
Education
Food and Cosmetic Control
Affairs
Self assessment checklist for GMP
In Cosmetic &Hygienic manufacturers
Code of document:GMP/F-003
Date of Issue: 10/2007
Review: 00
Review date:00
Page 9 of 19
18) If every container (e.g. box, drum, and bag) of raw material properly identified and can its
status be readily determined?
19) If the current formulations and manufacturing instructions provided to the people
producing the batch?
20) If all the necessary batch information recorded for: a: Raw material batch number? B: raw
materials quantities? C: temperature and mixing time controls? D: corrections?
21) If repeated corrections are necessary, are these reported back to R&D?
22) If more than one lot of a raw material is used, are both recorded with separate quantities?
23) If all major equipment that is used, recorded on the batch card /formulation document?
24) If rejected and out-of-specification materials and products identified, controlled and
quarantined to prevent their use?
25) If quality control approve the reprocessing of out-of-specification bulk material?
Auditing
Site
Auditing Case
Results
Yes
Filling&
packagin
g
1) If the equipment of packaging section is appropriate?
2) If frequentation of the personnel to the packaging section is well arranged?
3) If frequentation of the material processed and packed in the section is appropriate?
4) If worker` cloths of packaging section are appropriate?
Quality control confirmation:
Name and signature:
Date of confirmation :
NO
Notice
Ministry of Health & Medical
Education
Food and Cosmetic Control
Affairs
Self assessment checklist for GMP
In Cosmetic &Hygienic manufacturers
Code of document:GMP/F-003
Date of Issue: 10/2007
Review: 00
Review date:00
Page 10 of 19
5) If labeling regulation is considered? ( attach a sample of label )
6) If necessary tests are carried out on the packing material?
7) If the finished product maintains appropriate package?
8) If the list of allergenic material has been written on the label?
9) If the packaging time of the final product is appropriate?
10) If the available equipment in the packing section, such as balance, is calibrated?
attach documents )
11) Is rubbish and waste material properly controlled and disposed in a safe, timely
and sanitary manner?
12) If the filling equipment designed, constructed and located to facilitate its use,
cleaning and maintenance?
13) Are surfaces which are in contact with the product constructed of materials which
have been shown not to affect the product quality?
Auditing
Site
Auditing Case
Results
Yes
Filling& packaging
14) Is there a preventative maintenance program, with a schedule for all filling
equipment?
15) If labeling, capping, packing, and coding equipments kept clean?
16) If all rubbish containers clean clearly labeled and covered?
17) If every container (box, drum, bag etc.)Of bulk, packaging material and labels
properly identified?
18) If all bulk, packaging material and labels approved prior to filling?
19) If all packaging materials (e.g. bottles, containers, caps) covered when not in
Quality control confirmation:
Name and signature:
Date of confirmation :
NO
Notice
Ministry of Health & Medical
Education
Food and Cosmetic Control
Affairs
Self assessment checklist for GMP
In Cosmetic &Hygienic manufacturers
Code of document:GMP/F-003
Date of Issue: 10/2007
Review: 00
Review date:00
Page 11 of 19
use?
20) If filling specifications and quality standards available prior to the start of
filling? (Is it carried out?)
21) If the fill weight checked and maintained within the specified /legal limits?
22) If the weight checking equipment calibrated and documented?
23)Is there a written procedure for the proper repackaging ,control and reconciliation
or returns?(attach document)
24) If rejected components and products segregated and properly controlled?
25) If there have been established cleaning and disinfection systems (SSOP) for
production salon and equipment, if yes, are they carried out?(attach it)
(SSOP: Sanitary Standard Operation Procedure)
Auditing
Site
Auditing Case
Results
Yes
warehouses
1)If all the storages areas provide the correct and specified environmental conditions
for the storage of:
A: Raw material?
B: component?
C: bulk product?
D: finished goods?
E: flammable/hazardous?
F: cold storage?
G: return/reprocess products?
H: Disposal?
I: quarantine
Quality control confirmation:
Name and signature:
Date of confirmation :
NO
Notice
Ministry of Health & Medical
Education
Food and Cosmetic Control
Affairs
Self assessment checklist for GMP
In Cosmetic &Hygienic manufacturers
Code of document:GMP/F-003
Date of Issue: 10/2007
Review: 00
Review date:00
Page 12 of 19
2) If the storages have been shelved?
3) If the storages are controlled according to temperature and humidity?
4) If the storages maintain appropriate box pallets?
5) If the storages are equipped with any computer systems, and if the frequenting
documents are controlled?
6) If in warehouses uses electrical lift trucks?
7) If the warehouses have been designed in such a method that the first entry to the
store shall be the first leaving one? (' FIFO Regulation)
8) If the procedures for the receipt, identification, storage and handling of the
incoming products followed?
Auditing
Site
Auditing Case
Results
Yes
warehouses
9)Upon receipt ,and before acceptable ,If all containers examined visually for
identification
astocontents,damage,brokenseals,contamination,andor,compliancewiththe.proper
documentation:
A: If the drums clean or cleaned on receipt?
B: If all incoming deliveries weighed on receipt?
10)Dose the inventory include the :
A: allocated batch number?
B: suppliers lot number?
C: quantity?
11) If products stored away from walls and off the stone?
Quality control confirmation:
Name and signature:
Date of confirmation :
NO
Notice
Ministry of Health & Medical
Education
Food and Cosmetic Control
Affairs
Self assessment checklist for GMP
In Cosmetic &Hygienic manufacturers
Code of document:GMP/F-003
Date of Issue: 10/2007
Review: 00
Review date:00
Page 13 of 19
12) If non conforming raw materials and components identified and handled
according to written procedures?
13) If all raw materials marked with expire date?
14) Is there a system in effect to assure that expire product is not distributed unless
reexamined and approved by quality control?
15) If written procedures available, which describe, in sufficient detail, the handling
of returned goods and are they followed?
16) If cleaning of the storages is appropriate?
17) If the arraying of produced products in the storages is appropriate?
Auditing
Site
Auditing Case
Results
Yes
18) If the worker` cloths of the storages are appropriate?
19) If all of Raw materials and Finished products are stored in appropriate
conditions?
20) If the Non-Confirmed materials are separated appropriately and stored in
separated room for prohibition of using them?
1) If there is adequate space?
Laboratories
2) If the factory maintains any equipped physical-chemical laboratory?
3) If necessary physical-chemical tests are carried out on all Batches of finished
products?
4) If necessary tests are carried out on all consuming raw materials?
5) If the factory maintains any equipped microbiological labor?
6) If necessary microbial tests are carried out on all Batches of finished products?
Quality control confirmation:
Name and signature:
Date of confirmation :
NO
Notice
Ministry of Health & Medical
Education
Food and Cosmetic Control
Affairs
Self assessment checklist for GMP
In Cosmetic &Hygienic manufacturers
7) If there is R & D section? (R & D: Research & Development)
Laboratories
8) If there are any executive methods to work in the labor and confirmed operating
method with the units?
9) If there are documented methods for sampling, tests, confirming or refusal of
material, as well as maintaining of laboratory data?
10) If the available sensitive equipments in the labor maintain any specifications?
11) If the labor equipment are in accordance with the production lines?
12) If the labor maintains any appropriate ventilator?
13) If any of the raw material, intermediates and final product maintains any Batch
Records?
14) If the analysis sheets of each material conform to a valid reference (USP, B.P…)?
15) If the production date, expiry date, Batch number, reference name, test date,
signature of the labor responsible, and confirming stamp have been registered on the
analysis sheets?
16) If standard reference or working standard is available for each raw material?
17) If the factory maintains any system for Recall?
18) If the factory maintains any room to file the samples?
19) Which methods are used for stability of raw materials?
(Long-term,
accelerated), and under which conditions (temperature, humidity and ...) are the
methods evaluated?
20)If the quality unit have the authority and responsibility to approve or reject
specifications
21)Does the quality unit :
Review product records?
Investigate errors?
Evaluate complaints and investigate them if required?
Quality control confirmation:
Name and signature:
Date of confirmation :
Code of document:GMP/F-003
Date of Issue: 10/2007
Review: 00
Review date:00
Page 14 of 19
Ministry of Health & Medical
Education
Food and Cosmetic Control
Affairs
Auditing
Site
Self assessment checklist for GMP
In Cosmetic &Hygienic manufacturers
Code of document:GMP/F-003
Date of Issue: 10/2007
Review: 00
Review date:00
Page 15 of 19
Auditing Case
Results
Yes
NO
Notice
Laboratories
22)When samples are taken for testing
A: Are the containers opened, sampled and resealed according to written procedures,
in a way designed to prevent contamination of the contents?
B: Are the sample containers labeled with the product name , lot number ,date
,product container and the name of the person collecting the samples
23)If the calibration/ validation records for all appropriate equipment
A: Maintained
B: In an orderly and timely fashion
B: Readily available
24)If the microbiology facility isolated from other part of the factory
25)If there is a requirement for a change of protective clothing when entering and
leaving the microbiology laboratory
26) If there are segregated work areas for aseptic operations?
27) If there is a copy of the relevant procedures/test methods manual readily
available?
28)If the following tested are in accordance with the laboratory manual:
Process water?
Raw materials?
Packaging?
Bulk product?
Finished products?
Auditing
Site
Quality control confirmation:
Name and signature:
Auditing Case
Results
Date of confirmation :
Ministry of Health & Medical
Education
Food and Cosmetic Control
Affairs
Self assessment checklist for GMP
In Cosmetic &Hygienic manufacturers
Code of document:GMP/F-003
Date of Issue: 10/2007
Review: 00
Review date:00
Page 16 of 19
Yes
29)If all appropriate control tests carried out in accordance with the laboratory
manual
30) If the microbiology laboratory carry out environmental testing?
31) If the area have a clean and orderly appearance?
Laboratories
32)If laboratory records include:
A: Description of the sample received for testing with identification of source ,
quantity, lot number or other distinctive code ,date sample was taken and the date
sample was received or testing(one of the batch records attached)
B: The weight or measure of sample used for each test, where appropriate?
C: All data and calculations collected in the course of each test (including all graphs.
Charts and spectra from laboratory instrumentation ) properly identified to show the
specific material , container , closure , in process material , or finished product and
lot tested
D: The results of tests and how the results compare with established standards of
identity, strength, quality and purity?
E: The signature of the person who performs each test and the date (s) the tests was
performed?
F: The signature of a second person showing that the original records have been
reviewed for accuracy, completeness, and compliance with established standard?
G: Any modification of an established method employed in testing, including the
reason for the modification and validation?
H: The results of testing and standardization of laboratory reference standards,
reagents, and standard solutions?
Quality control confirmation:
Name and signature:
Date of confirmation :
NO
Notice
Ministry of Health & Medical
Education
Food and Cosmetic Control
Affairs
Auditing
Site
Self assessment checklist for GMP
In Cosmetic &Hygienic manufacturers
Code of document:GMP/F-003
Date of Issue: 10/2007
Review: 00
Review date:00
Page 17 of 19
Auditing Case
Results
Laboratories
Yes
NO
Yes
NO
Notice
33) If there is a documented procedure for dealing with new raw material?
34) If there is a documented procedure for the issue and revision of specifications and
methods of manufacture?
35) If all customer complaint samples are tested by the quality department and are the
results reviewed?
36) If records of complaints are maintained in a separate file?
37) If all raw materials are purchased according to a specification that has been given
to the supplier?
38)Does the specification contain :
A: Physical and chemical characteristics?
B: Strength / purity?
C: Microbiological specification where applicable?
D: Storage conditions and shelf life?
E: Pack size?
F: Hazard data as applicable?
G: Requirement for certificate of analysis where applicable?
39) Is there an approved list of suppliers?
40) If the water being applied for equipment production and cleaning, is put under
chemical and microbial tests?
Auditing
Site
Auditing Case
Results
T
ra
in
in
g
D
oc
1) If Company maintains the Q.A. group? (Q.A: Quality Assurance)
Quality control confirmation:
Name and signature:
Date of confirmation :
Notice
Ministry of Health & Medical
Education
Food and Cosmetic Control
Affairs
Self assessment checklist for GMP
In Cosmetic &Hygienic manufacturers
Code of document:GMP/F-003
Date of Issue: 10/2007
Review: 00
Review date:00
Page 18 of 19
2) If regular and scheduled training courses are arranged for personnel?
3) If the Company is inspected by M.O.H and/or. N.G.O Inspectors (Should the
response be positive, in the intervals? (With Complete Declaration)
4) If the Company has been inspected in the past by the experts of the "Nutrition
General Office and/or Iran Medicaments General Department"? Should the response
be positive, which lines have been inspected?)
5) If the factory is inspected internally?
6) If the Company maintains GMP certificate?
7) If the Company maintains ISO certificate?
8) If the Unit maintains identification card for all consuming raw material?
9) Are there adequate personnel available to perform, supervise and control all plant
activities?
10)Do the job descriptions include:
A: description of responsibilities?
B: The reporting relationship?
11)Is there written training procedure which includes :
A: Designated responsibilities for the training programmed?
B: The preparation of a training schedule?
C: The training of hourly and management personnel?
Envirinm
ental&sta
ff
hygiene
Auditing Case
Results
Yes
1) If recycling water is applied in the factory?
2) In which periods of time are the workers and personnel put under medical
Quality control confirmation:
Name and signature:
Date of confirmation :
NO
Notice
Ministry of Health & Medical
Education
Food and Cosmetic Control
Affairs
Self assessment checklist for GMP
In Cosmetic &Hygienic manufacturers
examinations?
3)If the number of hygienic services is enough for the Unit's staff?
4) Are there housekeeping procedures readily available for all areas of the whole
facility?
5) Are there adequate sanitary facilities and designated eating and smoking areas
separated form manufacturing areas?
6) Are the toilets, sinks and hand basins clean and sanitary?
7) Are there written sanitizing procedures readily available for the following areas?
8) Are procedures validated and regularly checked by the laboratory?
9) Is the presence of cleaning and sanitizing residues assayed by chemical or
biological means in the laboratory?
Quality control confirmation:
Name and signature:
Date of confirmation :
Code of document:GMP/F-003
Date of Issue: 10/2007
Review: 00
Review date:00
Page 19 of 19