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Posts from the ‘QMS’ Category

Proposed update to EU GMP Chapter 5 “Production”

February 13, 2012

Dominic Parry

What’s new in the latest version?

The EU GMP Chapter 5 on Production is currently being reviewed.  A draft update document is currently available.  This article is a commentary on the DRAFT version currently in circulation.  Many of the suggested updates are in-line with existing good practices.  Some of the main suggested changes are summarised below.  You should refer to the actual document, Chapter 5 Draft, for the full details.  There is no news on if and when this update comes into force yet. Read more

The Focus of Audits – Have we got it right?

February 2, 2012

Dominic Parry

Most people will have some involvement with being audited.  In general audits are classified into one of three different types; namely first party, second party and third party.  First party audits are often called internal audits or self-inspections.  Here you are audited by others from your own site.  Second party audits are either you auditing a supplier or a customer (of which you are a supplier) auditing you.  This leaves third party audits whereby you are audited by a Regulatory Authority or external body.  This also leave the notion of corporate audits; audits by people from within the same organisation but from another site.  Read more

Quality Assurance or Quality Control?

January 24, 2012

Dominic Parry

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.

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CAPA – time for a rethink?

January 24, 2012

Dominic Parry

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. Read more

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

January 24, 2012

Dominic Parry

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!

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