In-Process Quality Control (IPQC) Notes

usually performed within the production area. The performance of such in-process controls should not have any negative effect on the quality of the product or another product. In-process inspection and testing should be performed by monitoring the process or by actual sample analysis at defined locations and times. The results should conform to established process parameters or acceptable tolerances.

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Complaints and Recalls in Pharmaceuticals

All complaints and other information concerning potentially defective products must be kept and reviewed according to written procedures. In order to provide for all contingencies, a system shall be designed to recall, if necessary, promptly and effectively products known or suspected to be defective from the market.

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Self Inspection

Self-inspection is basically a method of objective overall review of one's own operation on aspects that may have on quality effect on quality assurance. In general, self-inspection aims at identifying defects whether of critical, major or minor nature.

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