Why batch manufacturing records are so important according to GMP?

According to good manufacturing practices (GMP) your each process should be documented properly to establish evidence that your process, operated within pre-established parameters to prove that the produced drug and dietary product meeting its pre-determined specifications and quality attributes.   Before establishing the importance of creating and maintaining batch manufacturing records, let’s understand what batch manufacturing records are:

Batch manufacturing record is a written document of the batch, prepared during pharmaceutical manufacturing process. It contains actual data and step by step process for manufacturing each batch.

Batch manufacturing record is like a proof that batches were properly made and checked by quality control personnel. This ensures that proper ingredients are added and each processing step is completed according to the SOP and also ensures uniformity in finished product in each batch.

A good batch manufacturing record format should include following parts:

1.Batch records

Batch records include master production and control records (MPCR) and batch production and control records (BPCR). MPCR includes name of the product, name and codes of API, batch formula, batch or code no., identification of equipment, line and location used, start and finishing date with processing and packaging.

BPCR is the replica of MPCR carries factual information like material usage, dispensing activities, component weights , product output quantities, lot details, manufacturing nonconformance’s, and quality sampling and test results all add to this batch history.

  2. Bill of Material

Complete list of raw materials needed for manufacturing the finished product with required quantity and weight.

3.General instruction for manufacturing

Clear instructions related to safety and health of operators, should be followed during the manufacturing process.

4.Equipment cleaning record

Checklist for the cleaning of all equipments used in the manufacturing of the batch with the previous product, batch and date of cleaning.

  5.Yield

Yield of the batch should be calculated at the end of every stage to calculate the process loss. Final yield should be calculated at the end of the manufacturing that should not be less than 99.00%.

6.Abbreviations

List of the abbreviations used in the batch manufacturing records (BMR)  should be made to understand easily.

7.History of Chances

At the last, list of all the changes occurred including the revision number and the date of change.

Batch manufacturing record is like a back bone in the current good manufacturing practices (cGMP), and very essential to stay compliance.