Our most popular GMP and QMS articles

29th January 2020

Some of our most popular articles

For some week-end reading!

Our most read articles in 2019

These are the 5 most popular articles on our website in 2019

Annex 1 2022 Section 10: Quality Control (QC)

This final article looks at the new requirements in section 10 on Quality Control. It is also a useful point at which to reflect on the 2022 version of annex and what might it mean.

Annex 1 2022 Section 9: Environmental and Process Monitoring

This article is covering section 9 which describes the annex 1 guidance for Environmental and Process Monitoring. Section 9 is now a centralized location for monitoring activities.

Annex 1 2022 Section 8: Production and Specific Technologies – part 3

In this final part of the article on section 8 we will look at Sterilization processes. The selection of a sterilization process should be based on scientific principles.

Annex 1 2022 Section 8: Production and Specific Technologies – part 2

This is the second part of the article covering section 8 of Annex 1 2022 and here we are looking at the requirements around Form fill seal and Blow fill seal.

Annex 1 2022 Section 8: Production and Specific Technologies – part 1

This next article in our series is about section 8, which is the largest section of Annex 1 and covers production and specific technologies

Annex 1 2022 Section 7: Personnel

In this article, we move onto the personnel section, section 7.

Annex 1 2022 Section 6: Utilities

In this article we expand upon the equipment section but looking at Utilities as described in section 6.

Annex 1 2022 Section 5: Equipment

In this article we look at the general requirements for the equipment used in the manufacturing of sterile products.

Our series of articles on the key roles in GMP have proven very popular

These articles were written over the last 5 years but are constantly referenced today too

Annex 1 2022 Section 10: Quality Control (QC)

This final article looks at the new requirements in section 10 on Quality Control. It is also a useful point at which to reflect on the 2022 version of annex and what might it mean.

Annex 1 2022 Section 9: Environmental and Process Monitoring

This article is covering section 9 which describes the annex 1 guidance for Environmental and Process Monitoring. Section 9 is now a centralized location for monitoring activities.

Annex 1 2022 Section 8: Production and Specific Technologies – part 3

In this final part of the article on section 8 we will look at Sterilization processes. The selection of a sterilization process should be based on scientific principles.

Annex 1 2022 Section 8: Production and Specific Technologies – part 2

This is the second part of the article covering section 8 of Annex 1 2022 and here we are looking at the requirements around Form fill seal and Blow fill seal.

Annex 1 2022 Section 8: Production and Specific Technologies – part 1

This next article in our series is about section 8, which is the largest section of Annex 1 and covers production and specific technologies

Annex 1 2022 Section 7: Personnel

In this article, we move onto the personnel section, section 7.

Annex 1 2022 Section 6: Utilities

In this article we expand upon the equipment section but looking at Utilities as described in section 6.

Annex 1 2022 Section 5: Equipment

In this article we look at the general requirements for the equipment used in the manufacturing of sterile products.

Our most popular articles on auditing

 

Annex 1 2022 Section 10: Quality Control (QC)

This final article looks at the new requirements in section 10 on Quality Control. It is also a useful point at which to reflect on the 2022 version of annex and what might it mean.

Annex 1 2022 Section 9: Environmental and Process Monitoring

This article is covering section 9 which describes the annex 1 guidance for Environmental and Process Monitoring. Section 9 is now a centralized location for monitoring activities.

Annex 1 2022 Section 8: Production and Specific Technologies – part 3

In this final part of the article on section 8 we will look at Sterilization processes. The selection of a sterilization process should be based on scientific principles.

Annex 1 2022 Section 8: Production and Specific Technologies – part 2

This is the second part of the article covering section 8 of Annex 1 2022 and here we are looking at the requirements around Form fill seal and Blow fill seal.

Annex 1 2022 Section 8: Production and Specific Technologies – part 1

This next article in our series is about section 8, which is the largest section of Annex 1 and covers production and specific technologies

Annex 1 2022 Section 7: Personnel

In this article, we move onto the personnel section, section 7.

Annex 1 2022 Section 6: Utilities

In this article we expand upon the equipment section but looking at Utilities as described in section 6.

Annex 1 2022 Section 5: Equipment

In this article we look at the general requirements for the equipment used in the manufacturing of sterile products.

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