The equipment qualification process in pharmaceutical industry has four stages, design, installation, operational, and performance qualification. Installation qualification is the second stage of the pharmaceutical equipment qualification process. It lays the...
Equipment and machinery have an indispensable role in pharmaceutical manufacturing and quality control. Hence, they must pass the design qualification stage fulfilling predetermined user requirement specifications. Design qualification is the first step of the...
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...
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...
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...
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...