Plasma for fractionation: South African Plasma Requirements

Transcription

1 Plasma for fractionation: South African Plasma Requirements Dr Jeh-han Omarjee Head: Microbiological Sciences NBI is a "not for profit" company committed to providing safe, cost effective, quality medicinal products

2 Industry NBI Profile Industry Profile Not-for-Profit, public benefit organisation Registered as a Pharmaceutical Manufacturer Schedule 4 medicines (prescription only) Registered with the Medicines Control Council (SA) Operate in strategic association with BTS in SA Largest biotechnology company in SA

3 British Pharmacopoeia Council of Europe Blood Directive Plasma Quality Requirements WHO Annex 2 &4 Annexure 14 MCC guide

4 Process towards approving a blood establishment for the supply of plasma for fractionation

5 PAPER BASED AUDIT

6 Minimum information requested from blood establishment Regulatory framework of blood transfusion service National standards for blood transfusion Quality Management System

7 Organisation and personnel Reporting system Documentation Internals audits Change control Systems Storage and Transport Quality Management System Equipment Validation Materials Viral marker testing Critical Computerized systems Quality Control and monitoring data

8 Minimum information requested from blood establishment Regulatory framework of blood transfusion service National standards for blood transfusion Quality Management System Donor selection

9 Donor Selection Measures to exclude infectious donations Positive identification of donors Exclusion criteria Donors Selection criteria VNRD Records and traceability of donors

10 Minimum information requested from blood establishment Regulatory framework of blood transfusion service National standards for blood transfusion Quality Management System Donor selection Blood collection

11 Blood collection Blood/plasma collection process Blood bags used and anti-coagulant Procedure of collection Labelling of units and samples Volume of blood /plasma collected Mixing Reconciliation

12 Minimum information requested from blood establishment Regulatory framework of blood transfusion service National standards for blood transfusion Quality Management System Donor selection Blood collection Blood processing into components (plasma)

13 Plasma Processing Premises-storagetransport Storage after Processing below -20 C or colder Storage facilities, validation, segregation procedures Holding of blood units Plasma frozen within 24hrs of collection Release of plasma Method of separation of plasma from RBC Freezing of plasma, method, freeze rate, impact of containers Packaging and Transportation

14 Minimum information requested from blood establishment Regulatory framework of blood transfusion service National standards for blood transfusion Quality Management System Donor selection Blood collection Blood processing into components (plasma) Testing of blood products

15 Testing of blood products Screening of blood/plasma for infectious markers Screening tests (HBsAg, anti-hiv anti-hcv) and assay validation Nucleic acid testing and assay validation Test kits Quality control of screening Systems in place to control the labelling, testing and the release of compliant plasma units Retention of samples (storage and temperature) Lookback

16 Minimum information requested from blood establishment Regulatory framework of blood transfusion service National standards for blood transfusion Quality Management System Donor selection Blood collection Blood processing into components (plasma) Testing of blood products Epidemiology data (HIV, HBV and HCV) and emerging diseases

17 Epidemiology data of donor population Request epidemiology data for the previous 2-3 years Analyse and review data based on screening tests Determine incidence and prevalence rates Residual risk

18 PHYSICAL AUDIT

19 Key criteria that will be assessed Compliance with the principles of GMP QMS system is established Compliance with standards A system that is operational for the issue of good quality and safe plasma

20 Paper audit Road Map to approval Physical audit Final approval from the MCC

21 NBI s Other Plasma Quality requirements Once supplier is approved

22 Artificial mini-pool testing Hepatitis A and Hepatitis E virus (non-lipid enveloped virus) Parvovirus B19 (<log4 IU/ml) Major GMP breakthroughs

23 Plasma Consignment

24 LIMS as the sentinel Plasma Reconciliation

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26 Q-ARM Artificial Pool testing (APT/mini-pool testing)

27 Artificial mini pool testing Inventory 40 Plasma boxes Verification and reconciliation of donations Removal of donation segments X 36 donations Pooling of donation segments for each box creating BOX POOLS Quality Assurance Packaging Manufacturing + Column 1 Column 2 Column 3 Column 4 Column 5 Row A B B B B B Row B B B B B B Row C B B B B B Row D B B B B B Row E B B B B B Row F B B B B B NAT and Serology Row G B B B B B Row H B B B B B HAV RNA and HEV RNA Positive

28 NBI s Other Plasma Quality requirements An electronic system to issue plasma to fractionator Plasma Master File

29 Plasma Master File (PMF) PMF is a compilation of all scientific data on quality and safety of plasma Request information to compile the PMF Plasma Origin Plasma Quality and Safety Epidemiology data The data is requested and reviewed annually

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