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

  1. 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)

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:

https://www.iddo.org/research-themes/medicine-quality

https://www.who.int/medicines/publications/drugalerts/en/

https://mon-expert-en-gestion.fr/fr/facturation/facture/detail?id=12281212

Finished Products 

  • 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 

Phamacopeoeias

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 

Stability

Quality control laboratories

Packaging, Labeling and Documentation

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).

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.

Generics

Storage and distribution

Manufacturing Practices