Date of Issue: 10/2007
Review: 00
Review date:00
Page 1 of 21 / Self assessment checklist for GMP
In Cosmetic &Hygienic manufacturers / Ministry of Health & Medical Education
Food and Cosmetic Control Affairs
GMP Self Assessment Report
of cosmetic &hygienic foreign manufacturers for importing their products to IRAN
Scope of assessment:……………..
Name ofAssessors:………
Country:………………..
Date:……….
Score%:…………
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( )
9) Production group:
Raw material: Cosmetics o Hygienic o packaged o
Finish products:Cosmetics 0 Hygienic 0 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? Yes0 No 0
(Mentioning the names of the countries)
14) If the factory is the main producer?0OR 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)
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-chemicalµbial)
26)If it is necessary, sampling of the finished products carriesout?
( 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 QC or QA confirmation
Name&signature Name&signature
Code of document:GMP/F-003Date of Issue: 10/2007
Review: 00
Review date:00
Page 1 of 20 / Self assessment checklist for GMP
In Cosmetic &Hygienic manufacturers / Ministry of Health & Medical Education
Food and Cosmetic Control Affairs
Name of manufacturer:
Address:
Auditing Site / Auditing Case / ResultsYes / NO / Notice
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?
Auditing Site / Auditing Case / Results
Yes / NO / Notice
Principles of foundation / 13) If the steam system is appropriate?
14) If there is installed any natural and mechanical ventilation system to decreaseAir pollution and control the environmental temperature?(storages-manufacturing-laboratories)
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
Yes / NO / Notice
Production Section: / 6) If the factory maintains any modern executive instructions (SOP) to work with the units and machineries?
(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 / NO / Notice
Production Section / 17) If bulk storage tanks clean, undamaged and suitable for use?
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 / NO / Notice
Filling& packaging / 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?
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 / NO / Notice
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 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 / NO / Notice
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
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 / NO / Notice
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?
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 / NO / Notice
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?
Laboratories / 1) If there is adequate space?
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?
7) If there is R & D section? (R & D: Research & Development)
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 orrefusal of material, as well as maintaining of laboratory data?
10) If the available sensitive equipments in the labor maintain any specifications?
Laboratories / 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?
Auditing Site / 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 / Auditing Case / Results
Yes / NO / Notice
Laboratories / 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?
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?
Auditing Site / Auditing Case / Results
Yes / NO / Notice
Laboratories / 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
Yes / NO / Notice
Training Documentation / 1) If Company maintains the Q.A. group? (Q.A: Quality Assurance)
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?