Title: Checklist of preliminary evaluation of registration documents of biologic products by technical director
Type:
Islamic Republic of Iran
Ministry of Health and Medical Education
Food and Drug Organization
√ Finalized
Draft
No.:
Date of Issue:
Document No.: 102-20-03
Name of Office: Biologic,Deputy for Drug
Generic name of product
Brand name of product
Dosage forms and amount of active ingredient
Product strength (dose or potency)
Manufacturer name and address
Importer name and address
Name of technical director
Official representative:
1.
The product is compatible with the official Iranian drug list in terms of name, dosage form, and amount of active ingredient.
2.
Initial approval from the legal commission for importation is available (documents are appended to this form).
3.
Drug master file, in accordance with the appended checklist, is controlled, completed and confirmed by the technical director.
4.
Plasma master file, in accordance with the appended checklist, is controlled, completed and confirmed by the technical director.
5.
Site master file, in accordance with the appended checklist, is controlled, completed and confirmed by
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the technical director.
6.
The original version of certificate of pharmaceutical product confirmed by Iranian embassy in the country of origin is appended.
7.
The original version of list of purchasing countries confirmed by authorities and Iranian embassy in the country of origin is appended.
8.
Factory subsidiaries and contracted factories and each one’s role in the process of manufacture are appended.
9.
The original version of certificate of plasma safety by the manufacturing company, including source of plasma, confirmation of steps of donor selection, tests conducted on plasma and virus removal and inactivation is appended.
10.
The original version of signature sample of qualified person for releases in the company and in health authority of the country of origin confirmed by Iranian embassy in the country of origin.
* The following documents must also be submitted, if available:
1- GMP certificate of the manufacturer by inspectors of the supreme department
2- Response of the food and drug control laboratory
3- Importation history
Drug Master File
With mention of page number for each heading
1- General information regarding the product:
 Number and volume of packaging
 Storage and transportation conditions
 Route of administration
 Indications and volume of injection compared to available references
 Necessary cautions about the product
2- Information regarding the manufacture process
 Formulation with mention of amounts for each constituent per drug unit
 Amount of each ingredient per one batch
 Manufacture process, including all steps of preparation, isolation and purification
-
In flowchart
-
Complete description of the step
 In-process Controls
 Validation of manufacture process with mention of results
 List of important equipment of the production line
 Information regarding reprocessing
 Results of tests of production consistency
3- Biologic substances used in manufacture:
 Name of substances
 Source of purchase
 Nature and function of substances in manufacture
 Results of controls conducted
 Health certificate of substances for BSE agent
 Health certificate of plasma albumin used in formulation
4- Information regarding primary substances:
4-1 viral vaccines
 Strain used (seed)
-
Information
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-
History
-
Confirmation of the strain by health authority in country of origin or international authorities
-
Results of tests conducted on the primary strain
-
Information of primary cell bank (MSB)
-
Information of secondary cell bank (WSB)
 Primary cell culture
-
Information
-
History
-
Information of secondary cell bank (WSB)
 Origin and results of tests conducted on serum and tripsin used in cell culture
 Health certificate of serum and tripsin for BSE agent
 Primary and secondary seed
-
Information
-
History
-
Results of tests conducted
 Information of culture medium
-
Complete composition of culture medium
-
Analysis certificate of substances used with mention of valid reference
-
Results of tests conducted on culture medium
-
If the vaccine consists of different constituents, information for each constituent must be provided separately and completely
4-3 Products derived from plasma/blood
4-3-1 virus removal and inactivation of Product
 Procedure of virus removal and inactivation of Product and its conditions
4-3-2 Evaluation of virus removal and inactivation of Product methods:
 Name and address of site of virus removal and inactivation of Product evaluation and brief history of the company’s activities of valid certificates
 Determination of steps of virus removal and inactivation of Product
 Type and species of viruses used
 Test procedure
 Final RF and interpretation of findings
 Original version of confirmation of evaluating studies of virus removal and inactivation of Product process
4-4 Products resulting from recombination technology
4-4-1 Information regarding gene and host
 Origin of the cloned gene
 Host properties
 Sequence of the induced gene and vector
 Gene expression
4-4-2 Control of cell banks
 Origin, storage condition, period of usability
 Control of viral contaminations (when using animal cell lines)
4-4-3 Production
 General description of fermentation steps
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 Probable infections and method of controlling them
5- Control of auxiliary substances (including all substances used in production, purification and formulation)
 List of all substances used in production, purification and formulation
 Source of obtaining
 Reference of substance control in accordance with international pharmacopeias or submission of SOP and validation
 Analysis certificate from origin and final product manufacturer
6- Control of intermediate substances
 Method of control
 Mention of valid reference for control or submission of SOP and validation
 Period of stability alongside results of tests conducted (in accordance with requirements of item--)
7- Control of final product
 Method of control
 Valid international reference for control
 Validation of control methods
 Analysis certificate
8- Control of Solvent
 Name and information of manufacturer (if solvent is obtained from other sources)
 Formulation
 Analysis certificate of constituents
 Analysis certificate of final product
 Period of stability with stability study’s test results (in accordance with requirements of item7)
 Period and results of stability study after filling to volume
7- Information regarding stability
 Batch numbers tested, alongside manufacture date, site and size of batch
 Test procedure (stability protocol)
 Storage conditions of tested samples
 Packaging type of samples
 Duration of stability
 Name and address of laboratory where tests are conducted (if tests are conducted elsewhere)
 Test results (numerical results, chromatograms, gel photographs, peptide maps, etc)
 Final conclusion
8- Information regarding packaging (final product and solvent)
 Type and material of packaging
 Analysis certificate of packaging materials
 Sample color label
 Sample product
 Sample leaflet
9- Information regarding clinical and subclinical studies
 Study methods
 Formula used in studies
 Results
 Reference
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11- Release documents
 Sample production protocol summary
 Original version of sample signature of release authorities in governmental center and manufacturing company, confirmed by Iranian embassy
 Sample plasma health certificate and batch release for the albumin used in formulation as auxiliary substance and sample albumin analysis sheet
 Sample health certificate of biologic substances used in formulation as auxiliary substance for BSE agent
 Sample of product’s analysis certificate
 Sample solvent’s analysis certificate
Name and signature of technical director
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