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cGMP AUDITS AND COMPLIANCE (Mumbai, India)
              

Posted on: November 14, 2017   
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Ad Type: Offered
Location: Mumbai, India
Category: Job Training (Jobs)    *** Post your ad in this Category & City
Posted By:   Marcepinc
Phone # 08689830000
Website:
Classified Details: (Viewed 86 times by 84 visitors)        
Fraud Protection
Facts about the cGMP AUDITS AND COMPLIANCE?
• cGMP stands for Current Good Manufacturing Practice regulation enforced by the US Food and Drug Administration FDA. India has become a priority location for the USFDA as it houses the largest number of FDA~approved drug manufacturing plants outside the US. India with its Rs.1.1 trillion drug industry, which largely makes generics, exported around Rs.50,000 crore of drugs in 2016~2017.
• USFDA has increased the number of inspections at FDA approved units. The number of FDA 483 and warning letters,import alerts issued to pharmaceutical companies globally, have risen over the years and have been asked to review and strengthen its CAPA Corrective Action Preventive Action practices.

Why Audits observation CAPA?

• CAPA CAPA stand for Corrective and Preventive Action. FDA and regulatory agencies are looking closely in how Pharmaceutical companies conduct their investigations, and CAPA is viewed as the central component of Quality Management Systems. Corrective and Preventive Action CAPA is a key part of any Pharmaceutical quality program, and yet many companies continue to do it wrong If FDA 483 and Warning Letter reports are any indicators. CGMPs provide the process that assure proper design, analysis, monitoring, and control of manufacturing processes and facilities. The purpose of your internal audits should be to deliver some kind of value to your business.
• GMP Quality System This is a process of assessing Quality System components, such as trend analysis, internal SOPs, Controlling change, specifications, input inspection, personnel development and Outsourced operation control. Assess CAPA Corrective and preventive action programs.

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