The PIC/S GMP code (and the FDA) specifies that product quality reviews must be undertaken. As part of this review there is a requirement to assess the GMP compliance of suppliers, based on a quality risk assessment, this is known as the GMP vendor management audit program.
In practice, this also means that it is possible to reduce full identity testing of materials if an audit has been conducted on the site of the manufacturer of the starting material.
Additionally, if your products are being manufactured by a contract manufacturer then the PIC/S GMP code specifies:
“The Contract Giver is responsible for assessing the competence of the Contract Acceptor to carry out successfully the work required and for ensuring by means of the contract that the principles and Guidelines of GMP as interpreted in this Guide are followed.”
It is your responsibility to ensure that your suppliers’ manufacturing processes meet the appropriate standards and regulations.
PharmOut can conduct on-site supplier audits on your behalf to ensure that their manufacturing activities are being executed according to your specifications and the applicable regulations.
- We have experienced and professional GMP auditors available to conduct supplier audits
- We also offer audit-readiness assessments (mock audits) of your facility
International Supplier Audit Tours
We often audit overseas suppliers for our clients – suppliers who may also supply you. You can register your interest in a shared audit for a specific supplier. This will allow you to share the costs of the audit with other customers of that supplier (with confidentiality preserved between all parties).
Our auditors are often travelling in countries across the Asia Pacific. You can register to be notified when they are going to a specific country. If you have a supplier in that country then we can schedule to audit them whilst we are there – with you only having to pay for our time on their site, not all the other travelling expenses.
Contact us to find out more or to request a quote.