Process Validation, SOP Development/Batch Production Records

Process validation is based on written procedures, and is thoroughly exercised to establish that the procedure can be performed as specified. This requires the development of standard operating procedures (SOP) for production and quality control (QC) testing as well as the identification of limits for various steps in production, criteria for acceptable starting material, and final product specifications. Once the production method and list of reagents have been finalized, the batch production record (BPR) is developed. This stage culminates with a series of validation runs to ensure the reproducibility of the process that results in a satisfactory product.

PACT cell processing facilities (CPF) have established written procedures and policies addressing all appropriate aspects of processing, testing, storage, distribution, quality control, and administration of cell therapy products. Each PACT CPF is responsible for documenting its own validation procedures and quality program effort. PACT provides support in the translation of laboratory protocols to clinical grade large scale manufacturing SOPs under the provision of a controlled good tissue practice (GTP) and good manufacturing practice (GMP) infrastructure. PACT will consider providing support in:

  • Optimizing manufacturing processes
  • SOP development
  • Establishment of product release specifications
  • CMC section development

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