Stock preparation product documentation

For products that are prepared extemporaneously at a regular basis or even for a limited stock, a product specific documentation (product file) is needed. This will include specifications, instructions, and records but also a pharmaceutical assessment of safety data, toxicity, biopharmaceutical aspects, stability, and product design. The product file should also include a product review as soon as a product is used repeatedly or over longer periods. 

In some situations, for example with very short-lived radiopharmaceuticals, conditional release before all QC tests are performed is necessary. As a consequence, process validation is important An immediate recall procedure must take place, when product quality is found to be insufficient Stock preparations usually undergo an extensive analytical control (see Sect. 34.9.2) and remain in quarantine until the QC is fuUy completed (see Sect. 34.9). The release is based on the assessment of the document control in combination with the analytical quality controls. During release, final reconciliation takes place. For certain preparations (e.g. aseptic preparations) also the results of monitoring of production conditions are included. 

The seed stock principle for the preparation and quality control of MCBs and WCBs is an essential part of cell banking procedures, regardless of the intended use for the cells. The size of each bank and the level of quality control used are generally dependent on individual requirements and facilities. However, where a cell line or its products is to be involved in procedures under the jurisdiction of regulatory authorities, the cell banking procedures, characterization and quality control must address specific requirements for procedures and documentation. Finally, the intended use of cells or their product must determine the level of quality assurance required, and the person responsible for exploitation of the cells or product must identify the appropriate quality standard and select an agency accredited to that standard. 

Veterinary medicinal products shall at least once a year be subjected to a detailed review, by which the records of preparations received and supplied shall be compared to the stocks held, and a report shall be drawn up of any discrepancies. This documentation shall be kept available to the National Board of Health for a period of 6 years. 

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