Supplier & Contractor GMP Auditing

Supplier Audit and Selection With management of observation responses and green light for approved supplier status
Audit and selection of key contactors And periodic re-audit
Technical Agreement Assistance with preparation and maintenance
CAPA audit Following supplier quality issues

Supplier Auditing

Directive 2004/27/EC (2001/83/EC as amended) – In order to approve an API source it is expected that an audit will have been conducted by or on behalf of the Manufacturing Authorisation holder.

The EU requirement for companies to audit their API (Active Pharmaceutical Ingredient) suppliers was initiated as a result of real quality and safety concerns arising from sub quality batches.

It is no longer enough to provide supplier approval solely through documentation (ie. pre-audit questionnaire, open part DMF review and certificate of analysis review), Supplier  approval such as this was unable to prevent sub standard API’s being available in the market.

We can help ease the burden on pharmaceutical manufacturing sites especially those with numerous API suppliers by providing additional resources to manage the supplier audit programme. To ensure compliance with the requirement  initially and continuing with any new supplier approval and updating with periodic re-auditing.

As we are experienced auditors we can help with initial selection of API suppliers and manage suppliers responses to observations so giving you the green light when approved supplier status is achieved.

Contractor Auditing

The MHRA regard the quality control testing, including stability testing, of investigational and marketed medicinal products as part of the manufacturing process.  Contract laboratories engaged in the Quality Control of IMPs or commercial products must be included on your Manufacturer’s licence.

Increasing numbers of companies are outsourcing the testing to contract laboratories and we can help by providing assistance in auditing such laboratories ensuring they are operating in compliance with the EU Guide to GMP.