Audit and Guideline

Steps in Managing the Pharma Audit

Steps in Managing the Pharma Audit Introduction To achieve its’ objective efficiently and cost-effectively an audit should be thoroughly planned, carefully structured, systematically performed, faithfully reported, and remedial actions progressed to a timely and satisfactory conclusion. As with most issues involving people, clear and effective communication with the relevant stakeholders is essential if business …

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Technical Report Series (TRS) Biologicals

Technical Report Series (TRS) Biologicals Chronological listing 68th report: TRS 1011: 2017 67th report: TRS 1004: 2016 66th report: TRS 999: 2015 pdf, 1.31Mb 65th report: TRS 993: 2014 64th report: TRS 987: 2013 63rd report: TRS 980: 2012 pdf, 2.22Mb 62nd report: TRS 979: 2011 pdf, 3.23Mb 61st report: TRS …

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Computerised systems – EU GMP Annex 11

Computerised systems – EU GMP Annex 11 1. Appropriate controls for electronic documents such as templates should be implemented. Are there any specific requirements for templates of spreadsheets? H+V February 2011 Templates of spreadsheets help to avoid erroneous calculations from data remaining from previous calculations. They should be suitably checked for accuracy …

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Sampling of starting and packaging materials: Glycerol as per EU GMP

Sampling of starting and packaging materials: Glycerol as per EU GMP EU GMP guide annexes: Supplementary requirements: Annex 8: Sampling of starting and packaging materials: Glycerol 1. What is the background regarding international incidents of glycerol contamination? H+V December 2007 There is a history of sporadic reports from around the world of supplies …

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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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Risk-based approach as per EU Good Manufacturing Practice specific to Advanced Therapy Medicinal Products

Risk-based approach as per EU Good Manufacturing Practice specific to Advanced Therapy Medicinal Products Introduction ATMPs are complex products and risks may differ according to the type of product,nature/characteristics of the starting materials and level of complexity of the manufacturing process. It is also acknowledged that the finished product may entail …

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Pharmacovigilance

Pharmacovigilance Pharmacovigilance: Pharmacovigilance WHO defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects of marketed medicines or those under trial. The drug regulatory agencies have the responsibility of having a well-established pharmacovigilance system to monitor adverse reactions of drugs, during the …

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USFDA Generic Drugs: Questions & Answers

USFDA Generic Drugs: Questions & Answers What are generic drugs? A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a …

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