GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE JANUARY 2009 GUIDELINE ON THE REGISTRATION OF HUMAN PLASMA-DERIVED MEDICINAL PRODUCTS

ANNEX 1

CHECKLIST FOR THE REGISTRATION OF HUMAN PLASMA-DERIVED MEDICINAL PRODUCTS

Appendix Section

Document

Yes/No (Encl. #)

For official use

1.1.1 Plasma Master File 1.1.1 (a) Documents that verify each donor of source material has undergone a proper screening procedure to ensure that all established health criteria (including viral risks requirements) are met. Details on collection centers Data on epidemiology and blood-borne infections Selection/ Exclusion criteria Documents that verify each unit of source material has been tested non-reactive for Hepatitis B surface antigen, Anti-HIV-1 & 2 and Anti-HCV. Details of screening tests for markers of infection Documents that verify all steps in the processing of source materials are performed in licensed centres that conform to WHOs requirements. Look back system to trace the path of any donation Documents that verify all source materials are collected by aseptic techniques designed to assure the integrity and to minimise the risk of contamination of the source material and that the closure of the container used maintains a hermetic seal. Blood bags Plasma quality Plasma specification Documents that verify source materials do not contain any additive other than citrate or acid citrate dextrose anticoagulant solution unless it has been shown that the processing method yields a final product free of the additive to such an extent that the continued safety, purity, potency and effectiveness of the final product is not adversely affected. Documents that verify fractionator/ manufacturer and donation centre(s)/organisation responsible for collecting plasma complies with PIC/S GMP and procedures. a) Manufacturers letter of commitment.

1.1.1 (a) (i) 1.1.1 (a) (ii) 1.1.1 (a) (iii) 1.1.1 (b) 1.1.1 (b) (i) 1.1.1 (c) 1.1.1 (c) (i) 1.1.1 (d)

1.1.1 (d) (i) 1.1.1 (d) (ii) 1.1.1 (d) (iii) 1.1.1 (e)

1.1.1 (f)

1.1.1 (g)

HEALTH SCIENCES AUTHORITY HEALTH PRODUCTS REGULATION GROUP

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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE JANUARY 2009 GUIDELINE ON THE REGISTRATION OF HUMAN PLASMA-DERIVED MEDICINAL PRODUCTS

1.2.1 Manufacturing Process and Control 1.2.1 (a) Documents that verify all steps in the manufacture of the final product are conducted in licensed establishments for that purpose. All handling and processing techniques employed should conform to current relevant international GMP guidelines. Documents that verify each batch of source material intended for manufacture has been tested for hepatitis B surface antigen, antibody to HIV-1 & 2, antibody to Hepatitis C Virus, and HCV RNA. Details of plasma pooling Documents that verify the processing method used does not affect the integrity of the product and has been demonstrated to consistently yield a product. Processing methods used for the manufacture of products intended for IV use should have been shown to consistently yield a product that is safe for IV injection. Documents that verify processing steps are conducted to minimise risk of contamination from pyrogens, microorganisms, or other impurities. Preservatives to inhibit growth of microorganisms are not used of added to the product at any stage of processing. Details of the manufacturing process Details of process control Details of assessing the risk for viral transmission Statement on whether the physical, chemical and pharmaceutical properties of the finished products comply with the relevant United States, British or European Pharmacopoeial requirements. Details of product testing Details of containers Stability data container closure system/shipping

1.2.1 (b)

1.2.1 (b) (i) 1.2.1 (c)

1.2.1 (d)

1.2.1 (d) (i) 1.2.1 (d) (ii) 1.2.1 (d) (iii) 1.2.2

1.2.2 Drug Product

1.2.2 (a) 1.2.2 (b) 1.2.2 (c)

HEALTH SCIENCES AUTHORITY HEALTH PRODUCTS REGULATION GROUP

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