Who is concerned?


Those who:
-manufacture and package excipients for pharmaceutical use
-supply and distribute excipients for pharmaceutical use

The context

The European regulations expressly set out that the holder of the manufacturing authorisation of medicinal products for human use ensures that  excipients are suitable for use, by ascertaining what the appropriate good manufacturing practice is. The verification shall be carried out on the basis of a formalised risk assessment  that takes into account requirements  under other appropriate quality systems, as well as the source and intended use of excipients. EXCiPACT® is an international certification scheme managed by EXCiPACT asbl which defines the requirements of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) as well as   Quality System requirements in accordance with the ISO 9001 standard, to be implemented in the production, supply and distribution of excipients for pharmaceutical use. The  EXCiPACT® GMP  and EXCiPACT® GDP certificates can be granted by registered EXCiPACT asbl certification bodies only, such as Certiquality.

EXCiPACT® GMP and EXCiPACT® GDP mainly regulate the following aspects:
- Personnel (organizational structure, training, hygiene and health);
- Management, cleaning, and maintenance of premises and equipment;
- Purchase and monitoring of raw materials and packaging materials;
- Manufacturing, packaging, release, storage and distribution of excipients for pharmaceutical use;
- Approval and monitoring of sub-contractors;
- Management of non-conforming product, re-works and product ‘recall’;
- Management of deviations and changes;
- Management of improvement through corrective and preventive actions;
- The documentation (procedures/operating instructions/ records) necessary for a correct management of manufacturing, control and delivery processes of excipients for pharmaceutical use.



The service

Certiquality is a certification body registered by EXCiPACT asbl to issue site-based certificates in accordance with the EXCiPACT® GMP and EXCiPACT® GDP schemes. 

The main steps of the certification process to include:

- Stage 1 certification audit, necessary to determine the Organisation’s preparedness with respect to the EXCiPACT® GMP and/or EXCiPACT® GDP requirements;
- Stage 2 certification audit, necessary to assess the compliance of the Organisation’s management system with the requirements of EXCiPACT® GMP and/or EXCiPACT® GDP, through an analysis of documents and on-site observations;
- After approval by Certiquality’s Independent Ccertification Board, the  conformity certificate and final audit report can be issued..
- Performance of annual surveillance audits and 3-year certification renewal audits.

For the companies that are already certificated to the ISO 9001 standard by Certiquality, the conformity certification audit and subsequent periodical audits can be carried out at the same time as the already planned activities, like surveillances and renewals.  

The certification process