Professional Documents
Culture Documents
drastically reduced the production cost for companies, there is a heightened supplier risk
and lack of visibility into supplier processes. To gain an insight into supplier processes
and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the
According to PIC/S GMP code, it is your sole responsibility to ensure that the supplier’s
manufacturing processes, analytical tests and examinations are carried out reliably by the
supplier and are in compliance with the applicable standards and regulations. After the
audit, supplier must provide an appropriate corrective action plan with measures that will
Quality Policy
Looking into the details of supplier’s quality systems should be utmost priority during a
vendor’s site.
Training and Accountability
All the high quality machines, processes and tests may well go down the drain if the
vendor’s workforce is not fully prepared to implement them. Make it mandatory that the
supplier has appropriate training program for new employees to meet the current GMP
quality requirements. Accountability is the key if you want the supplier to maintain
integrity and consistency. If management comes forward to own the responsibilities for
manner.
General Organisation
A well-organized and clean manufacturing facility reduces the chances of hazards and
contamination. By auditing the vendor’s workplace, you can have a fair idea of how
seriously the employees take their work. Do they pay attention to details? Organizational
culture in the workplace apprises you of various facets of the supplier and may improve
Supply Access
Your suppliers also rely on other suppliers for raw materials to manufacture goods for
you. When conducting a GMP supplier audit, evaluate your supplier’s access to various
supplies. Because if your vendor fails to get an item from his supplier, eventually you
Steps-by-Step Guide to GMP Supplier Audit
Supplier auditing is a necessary part of quality management system. Before signing a deal
with a new supplier, you should conduct a thorough GMP supplier audit to ensure that the
1 - Schedule a time for audit by contacting the supplier. Observe how they respond to
your proposal of performing supplier audit. Allow them certain time for preparation; it
would benefit both the parties. Inform the vendor on who the lead auditor will be and
2 - Prepare the outline of your audit plan and review the vendor’s performance history.
Generally, audit plan depends on reason behind conducting supplier audit. For example,
if a discrepancy has been reported in the production area, you should spend more time
evaluating it.
3 - Conduct the audit as scheduled, at the same time keep the supplier’s schedule in mind.
Their activities shouldn’t be hindered. Take a note of how the supplier’s team welcomes
and greets you because thisreflects the ethics and principles of the vendor.
4 - Take an inspection tour to the manufacturing premises, have a close look at the
equipments and safety issues, pay attention to the GMP operations and waste disposal.
Do not miss the supplier’s shipping policies, workforce strength and attitude of
transportation fees. Keep taking notes throughout the process. It will help you when
6 - Write down the complete evaluation report and support your points with evidences.
Discuss these with the supplier’s team because they may also have certain concerns.
When conducting the GMP supplier audit, keep your vendor as a partner.