Skip to content

Archive for

Basic audit findings and clauses

February 28, 2012

Dominic Parry

When you are auditing you will often find non-conformities. These occur when the department, process or organisation that you are auditing is not following a requirement of the standard that you are auditing against. For many of you who perform audits in the pharmaceutical industry – the standard that you will audit against is GMP. It is important that any non-conformities are linked with the standard that you are auditing against, so non-conformities against GMP must be linked to the relevant clause of GMP.

 

Read more

Documents required by EU GMP

February 24, 2012

Dominic Parry

The following lists the specified documented procedures required by EU GMP.  It is worth pointing out that many times in GMP there is a requirement to have a “procedure”, but this is not the same as a “documented procedure”.  There are many activities that you do that are “procedures”, such as how you get in the car in the morning (unlock the door, adjust the seat, fasten seat-belt, start the engine, and so on), but this is (hopefully) not a “documented procedure”!  “Documented procedures” are often referred to as Standard Operating Procedures (SOPs), but they do not have to be called these.

Read more

Proposed update to EU GMP Chapter 2 “Personnel”

February 22, 2012

Dominic Parry

This article provides an overview of the current proposed changes to EU GMP Chapter 2 on Personnel.  As with similar blog articles before on Chapters 4, 5 and 8 readers are reminded that the proposed update is still in the DRAFT format (Chapter 2 Draft) and is therefore not yet a requirement of GMP at the time of writing.  Readers should also refer to the actual document for full understanding.

Read more

Calibration

February 20, 2012

Dominic Parry

Around a pharmaceutical manufacturing site there will be many measuring devices that require calibration.  GMP requires the calibration of such devices with similar requirements in both EU and USA GMP, as can be seen below: Read more

Proposed update to EU GMP Chapter 8 “Contract Manufacture and Analysis”

February 17, 2012

Dominic Parry

This article provides an overview of the current proposed changes to EU GMP Chapter 7.  As with similar blog articles before on Chapter 4 and Chapter 5 readers are reminded that the proposed update is still in the DRAFT format (Chapter 7 Draft) and is therefore not yet a requirement of GMP at the time of writing.  Readers should also refer to the actual document for full understanding.

Read more

%d bloggers like this: