Home / Audit and Guideline / Link For Guideline

Link For Guideline

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 …

Read More »

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 …

Read More »

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 …

Read More »

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 …

Read More »

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 …

Read More »

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 …

Read More »

WHO Guideline

WHO GUIDLINE FOR PRODUCTION WHO good manufacturing practices WHO good manufacturing practices for pharmaceutical products: main principles(Annex 2, WHO Technical Report Series 986,2014) Active pharmaceutical ingredients (bulk drug substances) (Annex 2, WHO Technical Report Series 957,2010) Pharmaceutical excipients (Annex 5, WHO Technical Report Series 885,1999) WHO good manufacturing practices for sterile pharmaceutical …

Read More »

EU (GMP) Guidelines

EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines Part I – Basic Requirements for Medicinal Products Chapter 1 Pharmaceutical Quality System (31 January 2013) Chapter 2 Personnel (16 February 2014). Chapter 3 Premise and Equipment (1 March 2015) Chapter 4 Documentation (January 2011)  Chapter 5 Production (1 March 2015) Chapter 6 Quality Control (1 …

Read More »

ICH Guideline

ICH Guideline Link 1. ICH GUIDELINE INDEX I. Q1A – Q1F STABILITY Q1A (R2) Stability Testing of New Drug Substances and Products Q1B Stability Testing: Photostability Testing of New Drug Substances and Products Q1C Stability Testing for New Dosage Forms Q1D Bracketing and Matrixing Designs for Stability Testing of New …

Read More »