Introduction The COVID-19 pandemic presents an unprecedented challenge to healthcare, the pharmaceutical industry’s supply chain and personnel movement. Globally different support functions like API, excipient and packaging patterners to this industry are not able to respond with in pre-defined time frame. Apart…
read moreThe most important word in the pharmaceutical industry. Usually number of audit concluded based on the “What” and How? Few important examples are quoted below, What is the equipment requalification frequency? What is the HEPA replace frequency? What is the calibration frequency?…
read more FDA Audit – The Do and Don’t List, How to Prepare for a FDA Inspection,FDA Basics for Industry > What should I expect during an inspection?,What to Expect When Being Inspected – FDA
FDA Inspections: Face the Challenge Through Proactive PreparationTips to Help You Prepare for an FDA Inspection,Inspection Readiness
US food and drug administration Indian site inspections: An experience,Dealing with a “difficult” FDA investigator
Strategies For Managing FDA Inspection Compliance Risks
Now a days the topic “Data integrity and non compliance” is the hot topics. Lots of references available online that deals with the Data integrity issue. One of the major example am going to give today, that can be control by the management…
read moreWhy inspection ? • To assess & evaluate the ability of a facility to manufacture quality products which consistently meet specification and regulatory requirements. • To confirm and assure the validity of: Identification, traceability and integrity of lots Manufacturing & packaging procedures …
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