Open AccessRegulatory Procedure of Post Approval Changes and Comparative Requirements of EU and USA Regulatory Regions
Author(s) -
Trivedi Ankit,
Deshpande Shrikalp,
Zaveri Maitreyi,
Jain Praveenkumar,
Kolhe Kiran
Publication year - 2021
Publication title -
journal of pharmaceutical research international
Language(s) - English
Resource type - Journals
ISSN - 2456-9119
DOI - 10.9734/jpri/2021/v33i46b32944
Subject(s) - good manufacturing practice , european union , regulatory authority , regulatory science , business , risk analysis (engineering) , accounting , operations management , international trade , regulatory affairs , medicine , political science , engineering , public administration , pathology
Aim: The current research paper describes the “Regulatory procedure of post approval changes and comparative regulatory requirement of EU and USA regulatory regions”.
Study Design: The present study is a type of Retrospective analysis of Regulatory requirements and the reviewed data was subjected to systemic review. Understanding of the same led to several observations regarding regulatory requirements of EU and USA regulatory regions.
Place and Duration of Study: The present study was carried out at Amneal Pharmaceutical Ltd., Ahmedabad, Gujarat, India from January, 2021 to April, 2021.
Methodology: Several guidelines were profoundly reviewed to compare the requirements of post approval changes in EU and USA regulatory regions. Various regulatory review aspects were focused i.e. requirements for manufacturing sites addition/or Transfer, process parameters, container and closures, packaging and labelling of medicinal products.
Results: The post approval changes in manufacturing sites of solid or semisolid dosage form considered as a major change for USA while considered as Moderate change for EU. The transfer of manufacturing section is major variation for USA while it is a minor but immediate inform type for EU. Change in manufacturing processes, containers, labelling section of sterile products considered as major variation for both. Semisolid and solid categories are falling under the same type of variation for EU and USA regulatory regions.
Conclusion: This work demonstrated that the drug approvals in US, EU are the most demanding globally and the available guidance and procedures for the triggered changes are clear in both countries. Applicant should have scientific rationale to any change pertaining to Approved product ; Since the all change control are falling under the scope of Audit, so Applicant should maintain the all the records online.