Importance of Batch Record Review in manufacturing of drugs
Batch record review is an important process in a pharma manufacturing company to maintain the quality of products. It is a periodical process that should be performed within a fixed time interval. Every pharma company follows the process of following GMP.
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Introduction
- It is a brief explanation of the importance of batch records in the pharmaceutical manufacturing company.
- Explanation of the purpose of the batch record review process.
Importance of Batch Record Review
- It totally explains the role of batch record review in ensuring the quality of the product and all drug regulatory compliances and requirements.
- A detailed discussion of the potential consequences of failing to perform in right way batch record review, including product recalls drug regulatory actions, and damage to the reputation of the company.Â
Batch Record Review Process
The batch record review process includes the following steps
- Identification of critical process steps and all quality attributes
- Perform the review of batch record documentation for better accuracy, completeness of documentation, and compliance of the batch record with the SOPs and Master Formula record.
- Identification and investigations of discrepancies, deviations, and oos results.
- Record maintenance about batch record review findings and decisions
- Approval or rejection on the basis of review findings.
Challenges and best practices in batch record review
Common challenges in batch review records are possible like poor documentation, lack of clarity in the SOPs, and time constraints.
The presentation of best practices for an effective and efficient batch record review is listed below:
- Training in the depth of personnel involved in the batch record review process.
- Good use of electronic batch record system
- Standardization of the procedure of batch record review across a number of products and different facilities.
- a regular review of SOPs and their revision to prove the current best practice and all regulatory requirements.
Summary
Summary of the importance of batch record review to ensure the quality of the product and its compliance with regulatory requirements.
It focuses on the need for careful and extensive batch record review processes, and the implementation of best practices to fix the challenges and modify the review process.
References:
- Laafon Galaxy’s SOP for batch reviewÂ
