When we think of GMP Internal Auditing, we tend to think of Auditing a single building. Most Pharmaceutical Companies are single-site facilities, although many have several buildings, they are still really single sites. Typically, the GMP Auditors know the auditees, the processes and activities that are being Audited. Objective Auditing can be difficult.
We’ve often said that GMP Internal Auditing is a sampling. We don’t Audit everything, only bits and pieces. The question that is often asked, is what size should those pieces be? How many records should we examine? How many people do we ask a particular question to? How long do we observe a particular action? All […]
A Pharmaceutical Quality Management System should do more than just ensure only quality products go out the door. It should also be a vehicle for continuous improvement. In today’s economy, any organization that does not continually improve, is rapidly dying. Even we are not immune. So what does this mean for the Internal GMP Auditor? […]
The Optimizer Smart System, created by Impulse Dynamics, monitors heart activity and delivers non-excitatory electrical signals to the right heart valve.
India’s largest drug maker Sun Pharma on Monday said that it has received letter 483 (an observation of deviation in manufacturing practice) from the US Food and Drug Administration for its manufacturing plant in Baska Gujarat.
Bayer AG and Johnson & Johnson have agreed to settle more than 25,000 U.S. lawsuits alleging that their blockbuster blood thinner Xarelto caused unstoppable and in some cases fatal bleeding for a total of $775 million (588 million pounds), court documents on Monday showed
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.
