The Certification Scheme can only be undertaken by a Registered EXCiPACT Certification Body employing a Registered EXCiPACT Auditor. The certification process is summarised in the following eight steps:
Supplier selects a Certification Body from the approved list and provides them with information to issue a cost quotation, audit timetable and duration for a 3-year certification audit. This reflects the supplier’s audit scope and the organisational and operational complexity of the specified site.
Supplier and Certification Body sign an Agreement for a 3-year certification audit of a specified site that covers its scope, audit standard(s), audit duration, audit schedule, surveillance audits and an auditor from the approved list.
Stage 1 Audit: Auditor reviews supplier’s documentation against the audit standard(s), writes to the supplier to identify nonconformities, and agrees the time needed for them to be resolved before the Stage 2 detailed on-site audit commences.
Stage 2 Audit: Auditor undertakes a full on-site site inspection against the audit standard(s) and submits a report to include any major nonconformities to the Certification Body’s Independent Certification Board (ICB) for review and a certification decision.
ICB makes the certification decision and issues the certificate and audit report to the supplier. EXCiPACT issues an invoice to the supplier for the Certification Fee and on receipt adds the supplier’s details to the approved list of suppliers on their website and may issue a press release.
The certificate is valid for 3 years and surveillance audits are held at least annually to address all Scheme requirements including inter alia internal audits, actions on previous nonconformities, complaints, and QMS effectiveness. Written reports are sent to the supplier after each audit.
A recertification audit takes place at the supplier’s request before the date of expiration of the latest certificate to confirm the continued conformity to the current EXCiPACT standard(s).
If the supplier makes any changes to the scope of their certificate, or to the management and ownership, or becomes aware of legal proceedings with respect to product safety or legality, or of a product recall, they must immediately inform the Certification Body who will take appropriate action.
The detailed process may vary with each Registered EXCiPACT Certification Body.
Developed by excipient suppliers and users, the Scheme’s core objectives are (i) to demonstrate a safe, reliable, transparent pharmaceutical supply chain, and (ii) to reduce the audit burden, costs and resources for manufacturers, distributors and users of pharmaceutical excipients without compromising quality. The Scheme comprises the following components:
- GMP standard for excipients as an annex to ISO 9001:2015
- GDP standard for excipients as an annex to ISO 9001:2015
- GWP standard for excipients as an annex to ISO 9001:2015
- Certifying Body competency qualification as an annex to ISO 17021-1:2015
- Auditor competency qualification as an annex to ISO 17021-1:2015.
Full details are published as "EXCiPACT Certification Standards for Pharmaceutical Excipient Suppliers: Good Manufacturing Practices, Good Distribution Practices – Requirements for Auditor Competency and Third Party Audit Organisations Providing Certification of the Management System 2021" available either as a pocket-size booklet from firstname.lastname@example.org or by downloading here. The Chinese version of the standards is available here.
This publication updates the 2017 version. Some corrections were made to align the GMP and GDP sections to make identical the requirements for the same subject matter.
A new Annex for additional Requirements for Applying GDP to original, closed-pack Pharmaceutical Excipients (“GWP”) has been added. This is effectively a sub-set of the GDP requirements for this specific scenario and to keep the text simple any reference to GDP may also refer to the GWP annex as the context permits. Several clauses in the ISO 17021-1 annex have been clarified and the actions to be taken when suspending or even withdrawing a certificate have been made clearer. Remote audits have been allowed if conducted in accordance with the EXCiPACT instructions published on the website, which were necessary to accommodate the societal changes brought about by the COVID-19 pandemic.
To view the 2017 version please click here.
All of our Certification Bodies have been informed that the use of the 2021 Standards shall be mandatory for all new certifications, re-certifications and surveillance audits after 31 December 2021. This instruction should not affect the status of existing Certificate Holders.
The Scheme enables all pharmaceutical excipient suppliers to demonstrate commitment to GMP and GDP in the manufacture and supply of their products. This reduces the audit burden for the suppliers and their customers without compromising quality. The Scheme is being accepted within both industry and regulators and has already been used in place of hundreds of direct customer audits. Only EXCiPACT Registered third party Certification Bodies and Registered Auditors are cited on this website. The timescale from a supplier/Certification Body first contact to certification can be six months. Lists of our Certificate Holders, Certification Bodies and their Auditors can be found on the drop down items below The Certification Scheme
Certification Body Registration Requirements
Those organisations interested in becoming a registered EXCiPACT Certification Body should contact EXCiPACT asbl via email@example.com or click here in the first instance.
Auditor Registration Requirements
If you are interested in becoming an EXCiPACT Registered Auditor, please refer to the AUDITORS page of this website