EXCiPACT – International Pharmaceutical Excipients Certification

What is EXCiPACT?

EXCiPACT is an independent, voluntary, Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP) Certification Scheme for Pharma Excipient Suppliers.

Regulators require Excipient users to qualify their Suppliers based on GMP/GDP Audits.  Regulators have also indicated that Third Party Auditing of Suppliers is acceptable, if a creditable Certification Body issues Certificates and Audit Reports by employing qualified Auditors who are credible in GMP/GDP Standards and in the needs of the Pharmaceutical Industry.

The Scheme comprises:

  • GMP Standard for Excipients – Annex to ISO 9001
  • GDP Standard for Excipients – Annex to ISO 9001
  • Auditor Competency definition, training courses, exams and Registration Process – Annex to 17021
  • Certification Body Quality System Definition and Qualification Process – Annex to 17021

Why EXCiPACT Certification?

Benefits

  • Adds Value to the Pharmaceutical Industry
  • Provided by approved Third Party Certification Bodies
  • Third Party Certification can assist medicinal product manufacturers in achieving compliance with GMP and/or GDP Standards at reduced costs and impact on time and resource
  • Saves both Supplier and their Customers money
  • Reduces the number of audits and cost for Supplier and User(s)
  • Supported to key Regulatory Bodies
  • Helps excipient users identify qualified Suppliers
  • Patient Safety is Enhanced
  • More Robust than 1st/2nd Party Certification
  • Audit Reports based on unbiased, excipient GMP and/or GDP Practices
  • Allows Pharma Companies to redirect Internal Auditors to issue outside the GMP/GDP Standards’ Scopes
  • Regulatory Acceptance of accredited Third Party Audits for assessing Quality and Safety

Who Should get EXCiPACT Certification?

Pharmaceutical excipient Manufacturers and Distributors.

How it Works

Utilizing the Certification Scheme, an ISO 9001:2015 approved excipient Supplier contracts with an EXCiPACT approved Third Party Certification Body. 

The Supplier and Certification Body will agree on the Audit Scope and Standard to be used (GMP, GDP or both). 

Once Audit shows Compliance, the Certification Body provides the Supplier with an EXCiPACT Certificate and Audit Report.

Certification is valid for three years, which includes annual surveillance audits and verifiable the EXCiPACT website (www.excipact.org).

Certification Scheme

The Scheme enables all Pharmaceutical Excipient Suppliers to demonstrate commitment to GMP and/or GDP in the Manufacture and Supply of their products without compromising Quality.

Step 1:  Supplier selects a Certification Body from approved list.  A quote, audit schedule and duration for the 3-year Certification Audit is shared between both parties.  This will reflect the Supplier’s audit scope, the organizational and operational complexity of the specified site.

Step 2:  An agreement for the 3-year Certification Audit must be signed.  Scope, standard(s), duration, schedule, surveillance audit and auditor from approved list must me specified and covered.

Step 3:  Stage 1 Audit.  Auditor reviews Supplier’s documentation against Audit Standard(s).  Identifies nonconformities and agrees the time needed for the Supplier to resolve before Stage 2 Audit occurs.

Step 4:  Stage 2 Audit.  Auditor performs full on-site inspection against the Audit Standard(s) and submits a report to include any major nonconformities toe the Certification Body’s Independent Certification Board (ICB) for review and a certification decision.

Step 5:  ICB makes the certification decision and issues the Certificate and Audit Report.  EXCiPACT issues an invoice to the Supplier for the Certification Fee.  Once payment is received, EXCiPACT will add the Supplier’s details to the Approved List of Suppliers on their website.

Step 6:  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.

Step 7:  A Recertification Audit takes place at the Supplier’s request before expiration, to ensure continued conformity to current EXCiPACT Standards.

Step 8:  The Supplier must inform the Certification Body of: changes to the scope of their certificate, changes to the management/ownership, legal proceedings pertaining to product safety/legality or product recall.

*May vary with each Registered EXCiPACT Certification Bod

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