“A master production batch records (MPBR) is a detailed, step-by-step description of the entire production process for a specific drug. It is the document wherein the chemical and biological processes of drug manufacturing (developed during the phase of research and process development of the drug) are merged with the regulatory requirements of the FDA. A good batch record ensures the fundamentals of cGMP compliance while providing a practical set of instructions for the manufacturing technician or operator. The MPBR explains exactly how the product is produced, indicating specific types and quantities of components and raw materials, processing parameters, in-process quality controls, environmental controls, etc. To support the requirements of the production batch record (PBR) which is also known as the batch production and control record, the MPBR contains fill-in-the-blank spaces throughout the text to facilitate the documentation of events for each individual batch. In fact the PBR is an exact copy of an approved MPBR. A PBR is issued for each batch of product produced in the facility. A batch, by the way, is defined in the Code of Federal Regulations, Title 21 210.3: "Batch means a specific quantity of a drug or other material that is intended to have a uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacturing." For a cell-culture derived protein product, a batch begins with inoculation and then proceeds through harvest and purification (sometimes the final purification steps may have a separate batch record). There would be separate batch records for media preparation, equipment preparation (cleaning, assembly, sterilization, etc.), and scale-up for innoculum preparation. There would also be separate batch records for final product formulation, filtration, filling, lyophilization, sealing, inspection, and labeling. PBRs must be followed during production events, and the information and signature blocks must be completed as production proceeds. Production and QC personnel write the MPBR.”
This Document would be the proof that there was or wasn’t a shortage/problem.
We would also like a copy of the production log book ledger dating back to 7-1-2008.
Facts About Current Good Manufacturing Practices (cGMPs)http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm#
fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing
Take Care,
Jimmy B
No comments:
Post a Comment