EXCiPACT Certification

EXCiPACT Certification

Regulators require excipient users to qualify their suppliers based on GMP/GDP audits and they have 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 demonstrably credible in suitable GMP/GDP standards and in the needs of the pharmaceutical industry. EXCiPACT assembly is a non-profit organisation that owns and manages oversight of such an independent, high quality, third party Certification Scheme available to pharmaceutical excipient manufacturers and distributors worldwide.

CERTIFICATION SCHEME

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:

Step 1

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.

Step 2

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.

Step 3

Stage 1 Audit: Auditor reviews supplier’s on-site documentation against the audit standard(s) and 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.

Step 4

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.

Step 5

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.

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 the date of expiration of the latest certificate to confirm the continued conformity to the current EXCiPACT standard(s).

Step 8

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.

Why EXCiPACT Certification?

• 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 1^st/2^nd 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 Neozenith Help you to get EXCiPACT Certification:

• Gap analysis, review of the existing Quality Management System. This review is carried out through discussions and verifications of records during visits to the client organization. The pharma customer specific requirements are taken into consideration to make this activity effective.
• GMP based system designing and documentation (Records and Procedures). 100% documentation support is offered by Neozenith. This includes shop floor controls as well as control on documentation and records.
• Training on GMP and QMS related requirements
• Routine assistance and system verification to ensure compliance to the requirements.
• Internal audit and Management review
• Certification audit – Stage 1 and Stage 2
• Submission of action plan on audit observations
• Review of report by the certification authority and awarding the certificate to the organization.