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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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Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak

Guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home Published 9 April 2020 From: Medicines and Healthcare products Regulatory Agency Contents 1. Existing electronic systems 2. Paper documents that were approved with …

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WHO Guideline for Basic protective measures against new coronavirus and Myth busters

To prevent infection and to slow transmission of COVID-19, do the following: Wash your hands regularly with soap and water, or clean them with alcohol-based hand rub. Maintain at least 1 metre distance between you and people coughing or sneezing. Avoid touching your face. Cover your mouth and nose when …

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SOP to prevent the spread of COVID 19 infection at workplace

1.0 OBJECTIVE: To lay down a Standard Operating Procedure to prevent the spread of COVID 19 infection at the workplace. 2.0 SCOPE: This SOP is applicable to cover all the individuals entering into plant 3.0 RESPONSIBILITY: HR department to verify and ensure compliance of the procedure. All individual reporting to …

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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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Investigating Out-of-Specification (OOS) in Pharmaceutical Production

Investigating Out-of-Specification This topic provides how to evaluate out-of specification (OOS) test results.  the term OOS results includes all test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer. The term also applies to all in-process …

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USFDA GUIDElINES (Generic Drug )

180-Day Exclusivity When Multiple Abbreviated New Drug Applications Are Submitted on the Same Day (I)   Abbreviated New Drug Applications: Impurities in Drug Products   ANDAs: Impurities in Drug Substances; Chemistry, Manufacturing and Controls Information (I)   ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing and Controls Information (I)   ANDA Submissions …

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USFDA GUIDELINES(Current Good Manufacturing Practices/Compliance)

Current Good Manufacturing Practice for Phase 1 Investigational Drugs (I)   Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production (I)   Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography   PET Drugs — Current Good Manufacturing Practice (CGMP)   Pharmaceutical Components at Risk for Melamine …

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USFDA Guideline (Chemistry, Manufacturing, and Controls (CMC))

Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products   Analytical Procedures and Methods Validation for Drugs and Biologics   Changes to an Approved NDA or ANDA (Revised) (I)   Changes to an Approved NDA or ANDA Questions and Answers (I)   CMC Postapproval Manufacturing …

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Pharmaceutical Inspection Co-Operation scheme (PICS)

Pharmaceutical Inspection Co-Operation scheme (PICS) PIC/S GMP Guide (Last updated by PIC/S Secretariat on 12 February 2016) Documents for industry (PIC/S GMP Guide) PIC/S GMP GUIDE PE 009-12 Download PIC/S GMP GUIDE (INTRODUCTION) PE 009-12 Download PIC/S GMP GUIDE (PART I: BASIC REQUIREMENTS FOR MEDICINAL PRODUCTS) PE 009-12 Download PIC/S …

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