Скачать или смотреть Corrective and preventive actions (CAPA)

CA-PA Management

CORRECTION :In the first instance, correction or remedial action focuses on the immediate situation in order to eliminate an existing non-conformance or undesirable situation.

CORRECTIVE ACTION: A Corrective Action is a reaction to a nonconformity or undesirable situation that
has already happened

PREVENTIVE ACTION: A Preventive Action is a proactive approach and process for detecting non-conformances or undesirable situations that have not yet happened and prevents them before occurring.

CAPA methodology should result in product and process improvements and enhanced product and process understanding.

References:
1. Q10 Pharmaceutical Quality System , https://www.fda.gov/media/71553/download
2. CAPA within the Pharmaceutical
Quality System, https://www.fda.gov/media/85266/download
3. WHO Deviation Handling and Quality Risk Management (draft) https://www.who.int/immunization_stan...


This Video Presented By:
Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry)

About Myself:
I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In my career I worked with the F & D, Production and Quality Assurance department etc. I have a good exposure in several Sterile Green field and Brown field projects. Involved in various regulatory audit like CDSCO, WHO, USFDA,TGA,MHRA, GERMAN, UKRAINE, ANVISA-Brazil, INVIMA-Colombia, RUSSIA, IRAN, PMDA-Japan, South Korea etc.
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Sterile Injectable dosages form (SVP and LVP ) with liquid and lyophilized form
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