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Fda Warning Letter Quality Agreement

By Zach Arnold | April 9, 2021

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The chemical and microbiological quality control specifications that you or your contract testing laboratories (CTLs) use to test and release each incoming batch for use in manufacturing. The competencies of the quality control unit described in 21 CFR 211.22 were the most frequently cited topic, followed by written procedures; Variations in 21 CFR 211.100. The lack of written procedures and appropriate responsibilities for the quality unit observed has remained a trend in recent history, and its recent development has led to numerous caveats. Your company is a pharmaceutical manufacturer. Failure to comply with CGMP can significantly affect the quality, safety and effectiveness of the drugs you manufacture for your customers. It is important that you understand your responsibility to work in full compliance with CGMP and that you will inform your customers immediately (for example. B owners, sponsors) production or quality problems that may pose a risk to the patient. Your customer also remains responsible for supervising contract manufacturers to ensure that their products are manufactured in accordance with CGMP. A rehabilitation plan that ensures better management of the entire manufacturing cycle of all drugs. Provide a more data-based program that identifies sources of process variability and realizes that manufacturing (including production and packaging) meets the corresponding parameters and quality standards. These include, in its evaluation conditions, the adequacy of the equipment to the intended use, the quality of the raw materials, the determination of the capacity and reliability of each manufacturing process and its controls, the guarantee of appropriate and sufficiently detailed procedures to support manufacturing operations, as well as constant monitoring of process performance and product quality.

As we looked at in an article last April, in 2019, the FDA has seen a greater focus on compliance with over-the-counter drugs and other health product manufacturers. In a July 2019 column for Pharmaceutical Online, we analyzed these OTC-specific compliance trends, eliminating the following common problems in warnings. 1. Your company failed to set up or refuse a quality control unit and appropriate procedures for the quality control unit, with responsibility and refusal to approve or refuse all components, drug boxes, seals, process materials, packaging materials, labeling treatment and medicines, including manufactured medicines. , processed, packaged or contracted by another company (21 CFR 211.22 (a) and d)). 2. Your company`s quality control unit has not approved or refused any procedure or specification affecting the identity, starch, quality and purity of the drug (21 CFR 211.22 (c)). The offences mentioned in this letter are not designed as an all-inclusive list.

They are responsible for investigating these offences, identifying the causes, preventing their reoffending and preventing other offences. Your company has not been done in writing for many quality functions (quality assurance), for example.B. verification and approval of batch statements, release of lots, verification of a-specification results (OOS), cleaning, device qualification, stability control, control of clothing and samples.

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