It is the GMP Auditor’s behavior that determines whether the GMP Audit is perceived as being credible. It is the GMP Auditor that the auditee sees, not the Audit administration. With that in mind there are seven steps an Auditor can take to help ensure credible GMP Audits.
Those of us with a manufacturing quality background can easily explain the evils of variation in manufacturing. Variation in manufacturing leads to nonconforming product (defects). We readily recognize the two types of variation.
First Impression • Assessing the ability of a manufacturer to make your product according to your specifications • The purpose is firstly to determine if the Pharmaceutical Quality System (PQS) is adequate and they are operating in a state of control
The smaller the organization, the greater problem this can be. How do you take employees and make them impartial? Can in-house GMP Auditors truly audit without bias?
During the GMP Audit a question may be asked whether the laboratory has the correct number of appropriately trained staff.
What type of problems can be found during a Laboratory GMP Audit?
GMP Auditing is a Science, and an Art. It is easy to read an FDA, PIC/S, MHRA GMP Guidelines, or a Procedure and check to see if they are being followed.
Lack of time limits between product manufacture and filling Lack of filter validation for microbial challenge and extractables
• It is a regulatory requirement • GMP is a continuum of risk mitigation and a Supplier Audit is a way to mitigate the risk associated with that supplier
The first step in GXP Auditor training is to select Auditor candidates.
