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Questions and Answers on coronaviruses (COVID-19) WHO

Questions and Answers on coronaviruses (COVID-19) WHO 1.0 Question : What is a coronavirus? Answer :  Coronaviruses are a large family of viruses which may cause illness in animals or humans.  In humans, several coronaviruses are known to cause respiratory infections ranging from the common cold to more severe diseases …

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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   Pharmaceutical GuidanaceMr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India …

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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 –https://pharmaguidances.com Pharmaceutical GuidanaceMr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years …

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