Good manufacturing practices
The implementation and enforcement of Good Manufacturing Practices (GMP) in Blood and Plasma Collection Establishments is considered a priority as a tool to minimize the risk of transmitting currently known and emerging blood-borne diseases. This priority has been consistently highlighted by medicines regulatory authorities at the last International Conferences of Drug Regulatory Authorities (ICDRA) held in Berlin (1999), Hong-Kong (2002) and Madrid (2004).
GMP is a system for ensuring that products are consistently produced and controlled according to quality standards appropriate to their intended use and as required by the product specification. The adherence to GMP at all levels of the production process, from the donor to the recipient, is a prerequisite for consistent quality in the preparation of blood and blood products. The quality and safety of locally-manufactured products can only be ensured if national regulatory authorities with operational inspectorates implement and enforce appropriate GMP standards.
The assistance to National Regulatory Authorities in developing countries for the development of a common standard in the manufacture of blood-derived products was considered of the highest priority by the Expert Committee on Biological Standardization (ECBS) at its Meeting in 2003. The Committee considered that the implementation and enforcement of GMP in blood establishments at the regional and global levels will have a significant impact in preventing the transmission of blood transfusion transmitted diseases via blood products.
The implementation of GMP during blood and plasma collection procedures will ensure a consistent approach in the application of donor selection criteria for each donation, the prevention of errors during testing and, supporting traceability by adequate documentation of all relevant steps. The development of plasma contract fractionation programs will be supported in this way and closer collaborative links between regulatory authorities at Regional and global level will be promoted.
A number of educational programs and training Workshops are being jointly developed by WHO Headquarters and its Regional Offices, to respond to the above needs.
The GMP Guide for blood collection establishments, prepared under the auspices of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), is being used as the working document in these training activities.
The PIC/S GMP Guide has been widely tested and forms a reliable basis for further development, when required.
Countries with plasma fractionation activities; countries that are or will be involved in plasma contract fractionation activities in the near future and; countries whose medicines regulatory authorities have already expressed interest in enforcing GMP in their blood collection establishment are taking part in the Workshops.
Participants are drawn from National Regulatory Authorities (from both Pharmaceutical Inspectorate and Evaluation and Control departments) and National Blood Programs.
Technical and Regulatory Assistance to National Regulatory Authorities
- WHO Recommendations for the Production, Control and Regulation of Human Plasma for Fractionation
WHO Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products. WHO Technical Report Series (TRS) No. 924, Annex 4 (Adopted by ECBS 2001)
WHO Requirements for the collection, processing and quality control of blood, blood components and plasma derivatives. TRS No 840, Annex 2 (Adopted by ECBS 1992)
PIC/S GMP Guide for Blood Establishments (Jul 2004)
- Eleventh International Conference of Drug Regulatory Authorities (ICDRA); Workshop on Assuring quality and safety of blood products. Madrid, Spain (2004)
- Tenth International Conference of Drug Regulatory Authorities (ICDRA); Workshop on Safety of blood-derived products. Hong Kong, China (2002)
- Ninth International Conference of Drug Regulatory Authorities (ICDRA); Workshop on Safety issues of plasma-derived medicinal products. Berlin, Germany (1999)