The concept of the Qualified Person (QP), first established in 1975, is a unique regulatory requirement which applies within the European Union (EU). The only comparable situation exists within Member States of the European Economic Area (EEA) with whom the EU has reciprocal agreements. Each holder of an Authorisation to Manufacture products…
Test procedures for assessment of the quality levels of pharmaceutical products are subject to various requirements. According to Section 501 of the Federal Food, Drug, and Cosmetic Act, assays and specifications in monographs of the USP Pharmacopeia and the National Formulary constitute legal standards. The cGMP regulations [21 CFR 211.194(a)] require that…
Filtration can have significant effects on the results of analytical method validation, particularly in sample preparation and analysis processes. Filtration plays a role in method validation in several ways: Filtration study, the sample should be filtered through the proposed filter and the results should be compared with the unfiltered (centrifuged) sample. Acceptance…
Most relevant interview questions for freshers and experienced candidate applying for Regulatory Affairs positions in the US market, specifically in the context of generic submission (ANDAs): For Freshers 1. Can you explain what an ANDA is and its significance in the generic drug approval process? 2. How do you envision your role as…
Obtaining GMP authorization for a new pharmaceutical facility entails a detailed process to ensure regulatory compliance and safe product production. Here’s a comprehensive overview of necessary activities: 1. Facility Design and Construction: – Develop layout adhering to GMP, zoning different areas. – Construct with materials preventing contamination. 2. Cleanroom Design and Qualification: –…
Discovering straightforward tips for success in optimizing HPLC methods: 1. Use the appropriate column for your analytes and separation goals. 2. Optimize the mobile phase composition, including solvent type and concentration. 3. Adjust the pH of the mobile phase if necessary. 4. Optimize the flow rate to achieve optimal separation and resolution. 5. Use the…
Ever wondered about the difference between a completely new drug (NDA) 505(b)(1)and a hybrid drug (NDA)505(b)(2)? Let’s explore the contrast between these two pathways! A 505(b)(2) New Drug Application (NDA) is a regulatory pathway in the United States that allows for the submission and approval of certain new drug products. The name “505(b)(2)” comes…
Managing deviations and investigations efficiently is critical to ensuring product quality, compliance with regulations, and continuous improvement. An effective quality management system (QMS) must include procedures to identify, document, segregate, evaluate, and disposition production and post-production issues. You need to report and document the deviation as soon as it is identified. This includes…
