Revised Schedule M Deadline Extension Application Process
The CDSCO has now opened the portal for Revised Schedule M deadline extension application. Revised Schedule M deadline extension will be applicable only for small and medium scale businesses having a turnover of less than 250 crore. We have prepared a detailed guide...
DQ, IQ, OQ, and PQ in Pharmaceutical Industry
All pharmaceutical companies are required to abide by stringent regulations to ensure their products are safe and effective. Regulatory authorities specifically emphasize on qualification processes in pharma manufacturing facilities. The process of qualification aims...
GMP and Schedule M Audit Service for Pharmaceutical Facilities
All pharmaceutical manufacturing facilities in India are required to comply with the Schedule M guidelines. The guidelines are intended to change the way pharmaceuticals are manufactured in India bringing them at par with global standards. However, ensuring compliance...
Effective Risk-Based CAPA in Quality Management System
Corrective Action Preventive Action (CAPA) focuses on eliminating the root cause of non-conformities It is a systematic approach aimed at mitigating the risks of undesirable events and non-conformities. CAPA forms the core of quality management system (QMS) in...