List of official and reliable sources of information

Part 1: Manufacturer information

Approved manufacturing sites GMP Sites inspected by WHO pre-qualification Categories available: IPA, FPP, CRO, QCL. On the left there is a column with objects in blue. Click on “Inspections”. On this “Inspections” page, there is a list of points at the beginning of the text. Click on “Inspection Reports and OMSRIP”. This page will take you to the topic “WHO Public Inspection Report (OMSRIP)”, where you can click and search for inspection reports in the two “OMSRIP” links (current year reports) and ” WHORIP archived “(reports from previous years). If you click on “OMSRIP”, you can choose an inspection among the proposed categories. If you click on “Archived OMSRIP”, you can choose the year as well. The categories are: – Manufacturers of Finished Pharmaceutical Products (PPF) – Pre-submission Audits (APS) – Manufacturers of Active Pharmaceutical Ingredients (IPA – Contract Research Organizations (CROs) – Quality Control Laboratories (LCQ) European Union EudraGMDP Certificates Verification if a manufacturing site (all over the world) or a wholesaler (mainly in EU countries) has been approved after inspection by ANR Click on the GMP or GDP button at the top of the page. Or “Non-compliance report.” Enter the name of the manufacturer / distributor (add ‘*’ before / after the name if you are not completely sure of the spelling) and choose the country where the manufacturing site is located. is located, then click on the “Search” button The certificate can be downloaded by clicking on the selected line EudraGMDP non-compliance reports: same as before Choose “Non-complian this report. “Reports are listed by date United States: Search in the USFDA Inspection Classification Database Countries with strict regulatory authorities Definition of a strict regulatory authority (ARS) Annex 10, WHO Technical Report Series 961, 2011 ICH Members and Observers Inspection Bodies PIC / S Members – Participating and Partner Authorities Definition of the Rigid Inspection Body (ORI), Glossary QUAMED

Part 2: Product Information

Finished Products WHO List of Pre-Qualified Medical Products US FDA Provisional Approval List (PEPFAR) Global Fund Approved Products Scroll down the page until you reach “Lists of A, B and ERP-reviewed products” . There are lists for the WHO Prequalification Program, ARVs, Anti-Malaria, Anti-TB and all products (ARV, Anti-Malaria, TB) in Excel format. Vaccines prequalified by WHO Marketing authorizations for individual regulatory authorities may be listed on their website (see list of websites below). Active Pharmaceutical Ingredient CEP (adaptability certificate) on the DEQM site IPA pre-qualified WHO Permanent dossier of the drug – United States Pharmacopoeia International Pharmacopoeia European Pharmacopoeia (subscription required) British Pharmacopoeia (subscription required) American Pharmacopoeia (subscription required) Therapeutic equivalence WHO exceptions for bioequivalence studies. (There are tables in which you will find, for each product, criteria for solubility and permeability). Proposal to waive in vivo bioequivalence requirements for the WHO Essential Medicines List, for immediate-release solid forms. immediate distribution. Annex 8, WHO Technical Report Series, No. 937, 2006 Multi-Source Pharmaceutical Products (Generic): Guidance on Registration Requirements to Establish Interchangeability of Products Annex 7, WHO Technical Report Series, No. 937, 2006 Guide additional for organizations performing in vivo bioequivalence studies Annex 9, WHO Technical Report Series 937, 2006 Guide on the Selection of Comparative Pharmaceutical Products for the Equivalence Assessment of Interchangeable Multi-Source (Generic) Products Annex 11, WHO Technical Report Series, No. 902, 2002 Stability Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products Annex 2, WHO Technical Report Series 953, 2009 (with table 2 updated on 1 December 2010)Conditions of Stability Tests of the Committee of Experts WHO Specifications on Pharmaceutical Preparations Chapter 10, WHO Technical Report Series, No. 937, 2006 Quality control laboratories See Part 1, WHO Prequalification Sites for WHO-accredited CRO and LCQ. WHO Good Practice for Pharmaceutical Quality Control Laboratories Annex 1, WHO Technical Report Series, No. 957, 2010 English, French, Portuguese, and Spanish WHO Best Practices for Microbiological Pharmaceutical Laboratories Annex 2, WHO Technical Report Series, No. 961, 2011 Packaging, Labeling and Documentation Guides for Pharmaceutical Packaging WHO Technical Report Series, No. 902, 2002, Annex 9 More information: WHO Model Form for Adults and Children, 2013 (English) and 2011 (French) Summary Quality Information Summary (QIS) Summary of Product Quality Specifications (QIS Model)), which can be used with procurement and receipt documents to ensure that the specifications are respected.

Part 3: WHO documents

Some WHO documents dealing in particular with procurement activities to which QUAMED often refers are listed below (with their link). Note that all WHO publications and drug documentation are accessible and downloadable from: http://apps.who.int/medicinedocs/en/ WHO guidelines are published as annexes of the Technical Report Series (TRS). MQAS A Quality Assurance System for Supply Agencies (MQAS) – Recommendations for quality assurance systems focusing on pre-qualification of products and manufacturers, purchase, storage and distribution of pharmaceutical products. English version: Annex 3, WHO Technical Report Series 986, 2014 Version française: 2007 (an updated version should be published in 2015) Guide for inspection MQAS-based assessment tool for procurement agencies: help -memory for inspection. Annex 4, WHO Technical Report Series 986, 2014 Self-inspection tool MQAS-based assessment tool for procurement agencies: general principles. Draft for Comment, August 2013 Generic Guide to Submitting Documentation for a Multisource (Generic) Pharmaceutical End-Use Product: Quality Part Annex 4, WHO Technical Report Series, No. 970, 2012 Note: under revision – see working paper QAS / 13.522 February 2013 Pharmaceutical Development of Multisource Finished Products (Generic) – Points to Consider. Annex 3, WHO Technical Report Series, No. 970, 2012 Storage / Distribution Good Practice Guide Storage for Pharmaceutical Products Annex 9, WHO Technical Report Series, No. 908, 2003 Good Distribution Practices for Pharmaceutical Products Annex 5, WHO Technical Report Series, No. 957, 2010 Model Guide for the Storage and Transport of Time- and Temperature-Sensitive Pharmaceuticals. Annex 9, WHO Technical Report Series 961, 2011 Manufacturing Practices WHO Good Manufacturing Practices for Pharmaceuticals: Basic Principles Annex 3, WHO Technical Report Series 961, 2011 Revision of the 2011 Version: Annex 2, WHO Technical Report Series 986, 2014 Frequently Asked Questions (FAQ): Good Manufacturing Practices (GMP) in Pharmaceutical Practice. WHO Good Manufacturing Practices for Sterile Products Annex 6, WHO Technical Report Series 961, 2011 WHO Good Manufacturing Practices: Water for Pharmaceutical Use Annex 2, WHO Technical Report Series 970, 2012