A batch manufacturing record in pharmaceutical industry is information relating to the product and batch. It is a document that is intended to give a full and authoritative record of the manufacturing history of each batch of every product. The FDA defines a batch thus: “A specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture”.
System of checkpoints
In the light of this definition, batch manufacturing record in pharmaceutical industry has to be understood as one that is basically based on the master formula record. It is created, checked, ratified and sanctioned by the designated, competent technical person/s that is responsible for the organization’s production and quality control.
In order to avoid wrongful reproduction, batch manufacturing record in pharmaceutical industry involves use of methods such as photo reproduction.
What should go into it?
A typical batch manufacturing record in pharmaceutical industry ideally consists of these details:
- The product name
- Its batch number
- Date on which significant intermediate stage were commenced and completed
- The name of the person who is responsible for each stage of production
- Initials of both operators who carried out significant processes and the persons who checked these
- Details such as the quantity, batch number, quality control report number of each ingredient actually weighed, along with the amount of any recovered material that may have been added
- Details of in-process controls, their results and signature of person who performed these
- Whenever variation that exceeds expectation is observed, batch manufacturing record in pharmaceutical industry should make note of the theoretical yield and actual yield at every appropriate stage of production. These should be accompanied by an explanation
- Details of authorization of any deviation, if any was made
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