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- Traceability : Records of manufacture to enable the complete history of a batch to
be traced are retained. A system is available for recalling any batch of product
from sale or supply. - Training: Operators must be fully trained in SOPs.
GMP requirements are regulated by national and international legislature. For
example, Europe has the European Medicines Agency (EMA) and the USA has the
Food and Drug Administration (FDA). Australia, Canada, Japan, Singapore, and the
UK have highly developed GMP requirements. In other countries, especially in the
developing world, the World Health Organization (WHO) version of GMP is used by
pharmaceutical regulators and the pharmaceutical industry (WHO-GMP) (Fig. 6.4 ).
6.3 GMP Facilities for Cellular Products
GMP facilities are a basic prerequisite for GMP preparation of medicinal and cel-
lular products. The core of GMP facilities for cellular products is a clean room.
They are designed to create the appropriate production environment to prevent
product contamination by raw materials and cross contamination between batches
and to ensure that SOPs are followed as intended.
A clean room should be designed to generally comply with International Standard
ISO 14644—clean rooms and associated controlled environments. ISO 14644 con-
sists of eight parts:
Fig. 6.4 Eight hygiene principles of GMP: (1) primary production, (2) design and facilities, (3)
controls of operation, (4) maintenance and sanitation, (5) personal hygiene, (6) transportation, (7)
product information and consumer awareness, (8) training of personnel
P.V. Pham and N.B. Vu