First, begin with the yearly GMP Audit schedule. Involve as many of the auditees as practical. Take into account the strategic issues and once you are finished, stick to the plan (as best you can). Make sure all lines of communication stay open and the auditees are continually informed of the plan.
The purpose of a Pharmaceutical QMS GMP Audit is to achieve three separate goals; to ensure the QMS meets requirements, to make sure it is effectively implemented and to provide a means for continuous improvement. None of these goals can be obtained if the GMP Audits are under some type of suspicion.
Quality and consistency result from correctly following established SOPs. GMP Audits are performed to verify that SOPs are correctly and consistently followed. An SOP tells who does what, when, and where. An instruction tells how. They may be all on one document or separate documents.
Training is not enough. In order to have a successful GMP Auditing program, GMP Auditors must be not only trained, but competent. Competence comes from one source…demonstrated ability. Read more
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. Read more
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. Read more
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? Read more
During the GMP Audit a question may be asked whether the laboratory has the correct number of appropriately trained staff. Read more
What type of problems can be found during a Laboratory GMP Audit?
