(1993; 36 pages)
8. Lot processing records (protocols) and distribution records
8.1 Processing records of regular production lots must provide a complete account of the manufacturing history of each lot of a biological preparation, showing that it has been manufactured, tested, dispensed into containers and distributed in accordance with the licensed procedures.
8.2 A separate processing record should be prepared for each lot of biological product, and should include the following information:
- the name and dosage of the product;
- the date of manufacture;
- the lot identification number;
- the complete formulation of the lot, including identification of seed or starting materials;
- the batch number of each component used in the formulation;
- the yield obtained at different stages of manufacture of the lot;
- a duly signed record of each step followed, precautions taken and special observations made throughout the manufacture of the lot;
- a record of all in-process control tests and of the results obtained;
- a specimen of the label;
- identification of packaging materials, containers and closures used;
- a dated signature of the expert responsible for approving the manufacturing operations;
- an analytical report, dated and signed by the responsible expert, showing whether the lot complies with the specifications described in the standard operating procedure registered with the national control authority;
- a record of the decision regarding the release or rejection of the lot by the quality control department and, if the lot is rejected, a record of its disposal or utilization.
8.3 The records shall be of a type approved by the national control authority. They shall be retained for at least two years after the expiry date of a lot or batch of a biological product and be available at all times for inspection by the national control authority.
8.4 Records must make it possible to trace all steps in the manufacture and testing of a lot, and should include records of sterilization of all apparatus and materials used in its manufacture. Distribution records must be kept in a manner that permits rapid recall of any particular lot, if necessary.