Understanding the Pharmaceutical Batch Record Review

The pharmaceutical batch record review is a very crucial tool for ensuring both quality of the product process and compliance with regulatory requirements. It is an important means by which pharmaceutical organizations can formulate two important strategies:

1. A pharmaceutical batch record review is a very effective medium for keeping complete track of the firm’s day-to-day operations. A pharmaceutical batch record review helps the organization track its product from start to finish, thereby leaving no scope for ambiguity or uncertainty anywhere in the chain;
2. It helps the organization adhere in letter and spirit to regulatory requirements. Being in compliance with regulatory requirements is the surest means to avoiding collisions with regulatory authorities such as the FDA and others.

Regulatory guidelines from any regulatory body around the globe have a common requirement: that of maintenance or adherence to pharmaceutical batch record review standards if regulatory compliance is to be achieved. Review of production and quality control records are built into the approval process of a batch release. These are to be implemented at all the stages of the pharmaceutical batch record review, namely creation or alteration of master documents, along its distribution chain, records collection, and process for archiving and retrieving.

All regulatory authorities insist on the need and imperative of manufacturers to identify and exhaustively investigate the failure of a batch to meet its required specifications.

Another important requirement of a pharmaceutical batch record review is that investigation of a batch’s divergence, big or small, or inability for meeting specifications should be extendable to remaining batches of the same product, as well as related products which may have been involved in or associated with that particular failure or deviation or one similar to it. Pharmaceutical batch record review requires the organizations to write down records of the investigation and mention what corrective action was initiated, and what status this action has.

Regulations relating to pharmaceutical batch record review

All around the world, regulatory authorities have their respective regulations and standards pertaining to their requirements for meeting pharmaceutical batch record review standards. These are the current pharmaceutical batch record review standards around the globe:

• EU Regulations
• FDA
• ICH Q7 requirements
• Updates to ICH Q9/Q10 and EU-GMP Chapter 1
• Updates to the Counterfeit Directive

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