Batch production record an important tool in Pharma industry. Always I do believe that, every GMP document in the Pharma industry should be written and reviewed by subject matter experts (SMEs).
The insights of the document author and reviewer help in making the document written in logical sense with clear instructions, impart practical approach of the processes and procedures to be followed. Document written in logical sense with clear instructions always results in seamless execution of the processes and procedures, lesser deviations, achieve the right first time (RFT) approach with assurance for the process/product integrity.
Manufacturing of drugs often involves the key documents and procedures such as batch production record (BPR), batch manufacturing record (BMR), standard operating procedure (SOP), standard testing procedures (STP), various recording formats etc. Out of the mentioned documents, the batch production record (BPR) and batch manufacturing record (BMR) are the most important documents in terms of investigating the anomaly in the process or to verify the integrity of the process/product, since other documents are generally linked with the BPR/BMR.
The US FDA Subpart J – Records and Reports contains the following specific sections deals with BPR/BMR, 211.186. Master production and control records, 211.188. Batch production and control records, 211.192. Production record review. Similar citations are also observed in EudraLex volume 4 Part II / ICH Q7 various section such as, 6.4 Master Production Instructions (Master Production and Control Records), 6.5 Batch Production Records (Batch Production and Control Records), 6.7 Batch Production Record Review.
Each BPR/BMR is a GMP controlled document from the time the master document is authored/approved and it should be retained until two years past the associated product expiration dates (as per internal procedures). In few cases BPR/BMR need to be preserved for longer duration, if litigations, trials are there pertaining to patients safety.
BPR/BMR should contain the mandatory points such as BPR format number, KSM and proportionate other raw materials input quantity, critical process parameters (CPP) description, in-process sampling procedure and prompts for documentation of the obtained in-process results, verification by second person in case of CPP and raw materials charging, obtained yield Vs specified yield, verification of the packaging, labeling and transport instructions etc.
BPR/BMR mandatorily should include annexure sheet or provision for mentioning about the deviations or any abnormal observations noted during the batch manufacturing. It is important to document comments contemporaneously.
The basis for preparation of BMR/BPR is very important such as the product development report, technology transfer documents, any historical data etc.
Resource Person: Ravi ChinchalkarRavi Chinchalkar