Role of In-Process Quality Control (IPQC) in Reducing Deviations during ANDA-Oriented Pharmaceutical Manufacturing
Keywords:
In-Process Quality Control (IPQC), ANDA Manufacturing, Pharmaceutical Deviations, Generic Drug Production, Quality AssuranceAbstract
The noteworthy quality and regulatory concern in the generic drug manufacturing, whereby adherence to approved processes is mandatory, is In-Process Quality Control (IPQC) in Reducing Deviations During ANDA-Oriented Pharmaceutical Manufacturing. The Abbreviated New Drug Application (ANDA) route is centered rather on bioequivalence, manufacturing consistency and compliance with Good Manufacturing Practices, as opposed to full clinical trials. In this regard, even the minor changes in the process may cause deviations, batch rejections, or regulatory observations. This review examines the regulatory and quality framework of ANDA production and how IPQC plays an important role in preventing and controlling deviations. IPQC facilitates the real-time surveillance of essential quality attributes and process parameters throughout production and packaging, hence allowing for the early detection of nonconformities. IPQC is useful to minimize critical and major deviations, enhancing control of the processes, increasing the quality of material verification and allowing to manage deviation in a systematic way. The conclusion of the study is that successful implementation of IPQC is related to enhancing the process capability, lessening the batch failure, adherence to regulation, and continuity of production of safe, effective, and high-quality generic pharmaceutical products.
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