List of official and reliable sources of information
Part 1: Manufacturer information
Part 2: Product information
Part 3: WHO documents
Part 1: Manufacturer information
Approved manufacturing sites GMP
Categories are 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)
2. 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
3. United States: Search in the USFDA Inspection Classification Database
4. Countries with strict regulatory authorities
Definition of a strict regulatory authority (ARS)
5. Inspection Bodies
Part 2: Product Information
Alerts and reports of falsified or sub-standard products
Regular reports on medicines quality and alerts can be found on the following sites:
- 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
- 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
- Supplementary Guide 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 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)),
Résumé des spécifications qualité d’un produit (modèle QIS)), 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).
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.
- Guide for inspection MQAS-based assessment tool for procurement agencies: aide-memoire 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
- 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 and distribution
- Good Storage and Distribution Practices for Pharmaceutical Products TRS 1025 – Annex 7: Good storage and distribution practices for medical products
- Model Guide for the Storage and Transport of Time- and Temperature-Sensitive Pharmaceuticals. Annex 9, WHO Technical Report Series 961, 2011
- WHO Good Manufacturing Practices for Pharmaceuticals: Basic Principles Annex 3, WHO Technical Report Series 961, 2011 and Revision of the 2011 Version: Annex 2, WHO Technical Report Series 986, 2014
- 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