Quality Assurance or Quality Control?

QA or QC?

EU GMP states that Quality Control (clause 1.3) “is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures”.  In essence, QC is a sampling, testing, monitoring and checking activity.

CAPA – time for a rethink?

CAPA

Most manufacturing sites these days have CAPA systems – a mechanism to capture, record, control and approve or reject Corrective Actions.  Despite the fact that a lot of focus has been given to CAPA in recent years, there is a great deal of misunderstanding and a clear lack of clarity on what CAPA actually is.  This may explain why many organisations feel that they are still in “fire-fighting” mode – always dealing with yesterday’s problems rather than preventing future issues from occurring.

Auditing – Opening and closing meetings – How to do them professionally

Opening meetings

No matter what type of audit you are involved in it is essential that it starts and finishes well. Opening and closing meetings offer the forum to do this. A well run and professional opening meeting sets the scene for the audit and, if done well, creates a great first impression. Likewise, a well run closing meeting draws the audit to a close in a professional and controlled manner. TIP – if you are being audited, see how many of these points the auditor covers!

Proposed EU GMP Annex 16 update

The deadline for public comments on the concept paper on revising EU GMP Annex 16 – Certification by a Qualified Person and batch release is due in just a few weeks. Closing date is 31st January 2012.

Problem statements (from the concept paper)

• What is the minimum a Qualified Person (QP) must personally carry out when certifying a batch?
• What are the prerequisites for relying on statements from persons other than fellow QPs?