
Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA has launched a new search page for Quality documents. The page provides useful links to Pharma Quality related documents – Guidance’s, Compliance Programs, MAPP (Manual of Policies and Procedures).  USFDA website and archives have a large repository of useful resources for Pharma Quality, Regulatory, R&D and TechOps professionals – Guidance’s, Policies and Procedural Manuals which detail the regulatory and GMP compliance requirements. These documents are a rich source of information and learning for Pharma professionals. However searching and accessing the documents is not always easy with the information spread under different headings, categories and pages. For example the USFDA Guidance search page lists and links more than 2700 documents over varied subjects which includes Quality; however this page will not lead a User to a useful resource like a Complaince Program document Postapproval Inspections or a useful MAPP document Good Abbreviated New Drug Application Assessment Practices. The new Search page for Pharmaceutical Quality Documents provides links to around 245 Quality related documents and makes it easier for users to find the information they need in a more efficient manner. The page also provides links to Questions and Answers (Q&A) on cGMP Requirements, Q&A on Quality related Controlled correspondence and other useful links. Â
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