The PIC/S GMP code (and FDA) both specify that pharmaceutical product quality reviews must be undertaken by pharmaceutical manufacturers and other medical device and herbal supplement producers. As part of this product quality review, there is a requirement to assess the GMP compliance of all suppliers. Assessments of GMP compliance of suppliers are based on a quality risk assessment. This process is known as the GMP vendor management audit program.
Why is the GMP Vendor Management Audit Program an important part of a manufacturing risk assessment?
Manufacturing of therapeutic products is increasingly complex. Cost-pressures are leading pharmaceutical and medical device manufacturers to involve numerous new suppliers, as well as increasing employment in offshore production facilities. This can greatly increase quality risks in healthcare manufacturing businesses because responsible producers tend to be less aware of the potential GMP breaches (non-compliance) of their suppliers and/or overseas facilities and personnel than when suppliers, and personnel, are within close proximity. Not only does overseas pharmaceutical manufacturing increase your risks of producing substandard medications if GMP is breached, it makes many aspects of production more challenging, including training, management, record keeping, data integrity and reporting.
This is further complicated by increasing legislation requirements for transparent reporting of all manufacturing sources, suppliers and processes used to create or sell your product. As part of your current GMP requirements, you’ll need to make sure your GMP Vendor Management Audit Program is up to par or risk failing your GMP Audit.
GMP Vendor Management Audit Program | Definition and Details
Definition of GMP Vendor Management Audit Program
A GMP Vendor Management Audit Program is a formal process that aims to assess compliance with current GMP (or EU GMP) of all suppliers involved in the manufacturing of a pharmaceutical product, complementary medicine or medical device. The aims of a vendor management audit program are to reduce quality risks and increase transparency and visibility of all manufacturing processes; including collecting, analysing, testing and reporting findings and implementing corrective action plans (e.g. CAPA).
PIC/S, FDA and ISO require companies to conduct GMP audit(s) of suppliers, ideally through direct visiting of the manufacturing premises of the supplier, to evaluate their compliance at every stage of manufacturing and/or supply including the production, testing and quality assurance testing of the products.
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 at one of our offices around the world to find out more or to request a quote.