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Things to Do When FDA Staff Are on Site to Conduct an Inspection

The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection FDA Expectations • FDA conducts inspections to assess compliance with applicable laws and regulations • FDA expects: – Investigators to conduct inspections in a reasonable manner – Industry to …

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Question and Answers on WHO GMP

Question and Answers on WHO GMP Why is GMP important? Poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers. Poor quality medicines can damage health A poor quality medicine may contain toxic substances that have been unintentionally added. A …

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Questions and answers: GMP compliance for active substances (Annex 1: Manufacture of sterile medicinal products)

Questions and answers EU GMP guide annexes: Supplementary requirements 1. How should the integrity of sterilising filters be verified? H+V June 2007 Annex 1, paragraph 85 states, ‘the integrity of the sterilised filter should be verified before use and should be confirmed immediately after use by an appropriate method such …

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Questions and answers: GMP compliance for active substances (EU GMP guide part II)

Questions and answers Basic requirements for active substances used as starting materials: GMP compliance for active substances 1. How can GMP compliance for active-substance manufacturers be demonstrated? H+V April 2011 Directive 2001/83/EC as amended (Directive 2001/82/EC for veterinary medicinal products) states that manufacturing-authorisation holders are obliged to use, as starting materials, only active substances that have been manufactured …

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Questions and answers on Data integrity as per EU GMP(European Medicines Agency)

Questions and answers on Data integrity Data integrity Data integrity enables good decision-making by pharmaceutical manufacturers and regulatory authorities.It is a fundamental requirement of the pharmaceutical quality system described in EU GMP chapter 1, applying equally to manual (paper) and electronic systems. Promotion of a quality culture together with implementation …

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ANDAs: Stability Testing of Drug Substances and Products – Questions and Answers

Stability Testing of Drug Substances and Products A. General QUESTIONS  1: What is the scope of and implementation date for the FDA stability guidance? ANSWERS 1: The FDA stability guidance covers all new ANDAs under the Federal Food, Drug, and Cosmetic Act, section 505 (j), and DMFs (Type II for drug substances …

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Questions and Answers (USFDA)

Good Laboratory Practice Regulations — Questions and Answers (I)   Bar Code Label Requirements – Questions and Answers   ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers  

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Question & Answer on ICH

Question & Answer on ICH Question and Answer on ICH Q7 Question and Answer on Q8 ,Q9 and Q10   For More Pharma Updates Visit –http://pharmaguidances.com

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