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Periodic Review and Compliance in the Pharmaceutical Industry

Regulatory agencies update the guidelines regularly therefore, the review of pharmaceutical systems and documentation for cGMP compliance must be done regularly.
Compliance in the pharmaceuticals is key to success, not only because it is required by law, but because the pharmaceuticals industry is considered one that doesn't allow mistakes. That is, if you make a faulty cell phone, your customers will ultimately get angry at you, but nobody gets hurt. With pharmaceuticals, any kind of error in the production can cause from nothing to death, and it is certainly a good practice to play with peoples' lives.

FDA's Good Manufacturing Practices - GMP for pharmaceuticals manufacturing sets several rules for companies producing drugs. These regulations are not only US-based but follow also international regulations and they're quite alike other standards such as ISO 9001 quality standards protocols.

Periodic Review and ComplianceBut what is "quality"? From the FDA's cGMP: "Every pharmaceutical product has established identity, strength, purity, and other quality characteristics designed to ensure the required levels of safety and effectiveness". So quality means that a manufacturer can consistently produce the same product over and over again. Quality doesn't mean the product must be the best, it means that the manufacturer must be capable of producing what it proposed to produce.

To meet the requirements of periodic review for regulatory compliance in pharmaceutical manufacturing the quality system must be properly setup and retain adequate documentation about the production process and eventual problems occurred during a period for proper review later on.

Every quality system must contain a section where it explains how a periodic system review is conducted. A periodic review is a top concern within the system and is a responsibility of the company's management and ideally, it should be conducted at least once per year.

Under a quality system's approach, there are some basic requirements of periodic review for regulatory compliance in pharmaceutical manufacturing, which are;
  • Check if the quality policy and objectives are still appropriate or need adjustment
  • The result of internal audits must be evaluated
  • Customer feedback, including complaints
  • The current status of actions to prevent a potential problem or recurrence
  • Follow up on previous reviews
  • Any changes in the business environment that may affect the quality system
  • Check if the product characteristics meet costumers' needs.
When the quality system is being implemented, it is recommended that the systematic review should be a part of the management meetings agenda, so evolution can be followed up closely. As the system matures, the reviews can become less frequent, but as mentioned before, it should occur at least once per year, once per quarter can be considered an adequate rate for a mature system which does not encounter frequent small faults or a significant problem.

Eventually using an external auditor is also an interesting approach, as a qualified professional from outside the organization tends to have more criteria and is not influenced by any particular interest other than keeping the quality system adequate.
Related: How to Prepare for an FDA GMP Inspection

The results of a review should always be recorded and implemented using planned corrective and preventive actions. Normally the outcome of a review will result in improvements to the quality system; improvements to the product or production process; and/or realignment of processes.

Management should always refer to paragraphs 211.100, 211.180(e), 211.192, 211.198(b)(2) in the cGMP (Current Good Manufacturing Procedures) to be sure to meet the requirements of periodic review for regulatory compliance in pharmaceutical manufacturing.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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  1. Great post to recap the importance of quality review and some of its elements in this exercise.


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