Regulatory excellence lies in the details. Minor oversights in stability and analytical sections can trigger major delays or rejections. exploring three critical but often missed pitfalls: Missing Microbial Limits Justification in Stability for Non-Sterile Products Even non-sterile formulations must maintain acceptable microbial limits throughout shelf life. Failing to include microbial testing data during stability studies…
A Drug Master File (DMF) is one of the essential documents submitted to regulatory authorities to support drug approvals. It contains detailed technical information about the Active Pharmaceutical Ingredient (API). Two Parts of API DMF Open Part (Applicant’s Part): Closed Part (Restricted Part): What is LOA? A Letter of Access (LOA) is a formal agreement…
One of the key lessons we learned in addressing biowaiver requests for non-RLD strengths until 2022 was a fundamental misinterpretation of FDA’s 5% allowance for rate-controlling polymers (RCPs). Initially, we assumed that as long as the total amount of RCPs remained unchanged, we could increase one polymer by 5% and simultaneously decrease another polymer by…
21 CFR Part 11 is the FDA regulation for electronic records and electronic signatures. It establishes the criteria under which electronic records and signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. Key Requirements of 21 CFR Part 11 Electronic Records Electronic Signatures System Validation Security Controls Who Needs to Comply?…
Authoring a high-quality CMC (Chemistry, Manufacturing & Controls) dossier is crucial for regulatory approval. However, many submissions face delays due to avoidable mistakes. Here are some common pitfalls and how to avoid them: Inconsistent Data Across Sections Lack of Justification for Critical Parameters Poorly Structured or Redundant Content Incomplete Stability Data Failure to Address Regional…
The role of regulatory affairs professionals in the pharmaceutical industry is to ensure compliance with regulatory requirements and guidelines set by various regulatory authorities. ​ They play a crucial role in the development, approval, and post-marketing surveillance of pharmaceutical products. ​ Some specific responsibilities of regulatory affairs professionals include: ​ Regulatory Strategy Development They are…
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