Most Common Interview Questions For Regulatory Affairs Department.

Most Common Interview Questions For Regulatory Affairs Department.   1.What is Regulatory Affairs? Ans-Regulatory Affairs in a Pharmaceutical industry, is…

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How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -II)

How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -II) Out Of Specification( OOS ) :-  The all…

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How to Investigate Out Of Specification(OOS) Test Results….???( USFDA Phase -I)

How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -I) Out Of Specification(OOS) :-  The all test results…

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What is Data Integrity In Pharmaceutical Industry…???

What is Data Integrity In Pharmaceutical Industry…??? MHRA says,”The way regulatory data is generated has continued to evolve in line…

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What is Minimum Requirements of EU Agencies from Production section of Manufacturing site.?

Minimum Requirements in  Production section  for EU authorized Human Pharmaceutical products manufacturing site as per Eudralex Volume 4  part 1 Chapter 5: Production. …

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Minimum Requirements of Premises and Equipment as per EU Guideline before going for EU Regulatory Audit.

Minimum Requirements of EU for Premises and Equipment in Human Pharmaceutical products Manufacturing site  as per EU Guideline before going…

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Definitions of Pharmaceutical terms.

Definitions of Pharmaceutical terms as per WHO. The definitions given below apply to the terms used in this guide. They…

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Process Validation

Process Validation Successful  Process Validation gives assurance about produced Drug Quality . which is Drug should be fit for its…

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Good manufacturing practices for Pharmaceutical products

current Good manufacturing practices for pharmaceutical products (cGMP) As per WHO 1.1 Good manufacturing practice is that part of quality…

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Handling of Incidents and Deviations

Handling of Incidents and Deviations PROCEDURE: Definition: Departure from an approved instruction or established standard. Deviation shall be lodged when…

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