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.
But 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.
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.
But 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.
- 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.
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.
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