GMP:Blog

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24.06.2021 | NEWS

PIC/S: Adoption of EU GMP Annex 16 on QPs and Batch Release

PIC/S: Adoption of EU GMP Annex 16 on QPs and Batch Release

PIC/S has started the consultation process for the adoption of Annex 16 of the EU GMP Guide. It is a very important step towards international harmonisation of GMP requirements.

21.06.2021 | QUESTION OF THE WEEK

What significance do OEBs have?

read more ...

18.06.2021 | NEWS

EMA: Annual Report 2020 published

EMA: Annual Report 2020 published

As every year, the EMA now publishes its report for 2020, in which it outlines achievements, decisions and objectives of the year.

18.06.2021 | NEWS

FDA presents first global forum for generics

FDA presents first global forum for generics

In early June, the FDA unveiled the Generic Drug Cluster, the first forum for leading regulatory authorities to address the global development of generic drugs.

15.06.2021 | LOGFILE Feature 23/2021

Requirements for Balances Used in Pharmaceutical Production

Requirements for Balances Used in Pharmaceutical Production

Excerpt form the GMP Compliance Adviser, Chapter 11.B.3

10 min. reading time | by Christian Gausepohl, PhD

When selecting balances, technical aspects such as resolution, precision and weighing range must be taken into account, as must special design features. The installation location should be protected from draughts, sunlight and vibrations. The correct functioning of the balance must be regularly checked and documented. A distinction is made between a daily check of the weighing range and, for example, a monthly calibration of the entire operating range. In this excerpt from the GMP Compliance Adviser, you will find answers to the following questions:

What requirements must the installation location of a balance meet?
Which technical aspects and design features must be considered when selecting a balance?
How are the calibration limits determined?

14.06.2021 | QUESTION OF THE WEEK

What task do code readers have on a packaging line?

read more ...

10.06.2021 | ASK OUR EXPERTS

Are there any requirements regarding the microbiological monitoring of sewage drains in production rooms?

Are there any requirements regarding the microbiological monitoring of sewage drains in production rooms?

Should there be a microbiological monitoring program in place specifically for the drains?

First of all, drains in production rooms are not permitted in class A/B (EU GMP Guide, Annex 1 No. 50) which means the question should refer exclusively to production rooms starting with class C. Further information on the construction of drains can be found in EU GMP Guide Part I, 3.11.

08.06.2021 | LOGFILE Feature 22/2021

Design Qualification for Premises and Air Handling Units

Design Qualification for Premises and Air Handling Units

7 min. reading time | by Harald Flechl

The design qualification process may vary depending on the project and the client's requirements and may be carried out in two or three design phases.

07.06.2021 | QUESTION OF THE WEEK

What is an OEL value?

read more ...

01.06.2021 | LOGFILE Feature 21/2021

Contract Manufacturing: Technology Transfer Phases

Contract Manufacturing: Technology Transfer Phases

10 minutes reading time | by Chistian Gausepohl, PhD

01.01.2021 | AUTHOR

Michael Craig

Michael Craig

As a Principal Consultant at PAREXEL Michael Craig helps clients prepare their CTA, marketing authorisation and variation submissions as a CMC Subject Matter Expert and provides regulatory and technical input for lifecycle activities in European and international markets.

01.09.2020 | ASK OUR EXPERTS

Late, but not too late? How to best define the final time point of a stability study?

Late, but not too late? How to best define the final time point of a stability study?

16.06.2020 | ASK OUR EXPERTS

Validity period of FDA Certificates of Conformity?

Validity period of FDA Certificates of Conformity?

A manufacturer of pharmaceutical production facilities and containers must provide evidence of FDA conformity of materials in contact with the product, especially sealing materials. This repeatedly leads to discussions within the company about the validity period of corresponding supplier certificates. Is a certificate simply valid until a new certificate is issued because, for example, the material composition has changed? Is a 10-year-old certificate of conformity still valid?

01.06.2020 | AUTHOR

Ralf Gengenbach

Ralf Gengenbach

We warmly welcome Dr. Sandkühler to the GMP-BERATER experts team!

01.06.2020 | AUTHOR

PhD, Dennis Sandkühler

PhD, Dennis Sandkühler

We warmly welcome Dr. Sandkühler to the GMP-BERATER experts team!

24.06.2021 | NEWS

PIC/S: Adoption of EU GMP Annex 16 on QPs and Batch Release

PIC/S: Adoption of EU GMP Annex 16 on QPs and Batch Release

PIC/S has started the consultation process for the adoption of Annex 16 of the EU GMP Guide. It is a very important step towards international harmonisation of GMP requirements.

18.06.2021 | NEWS

EMA: Annual Report 2020 published

EMA: Annual Report 2020 published

As every year, the EMA now publishes its report for 2020, in which it outlines achievements, decisions and objectives of the year.

15.06.2021 | LOGFILE Feature 23/2021

Requirements for Balances Used in Pharmaceutical Production

Requirements for Balances Used in Pharmaceutical Production

Excerpt form the GMP Compliance Adviser, Chapter 11.B.3

10 min. reading time | by Christian Gausepohl, PhD

When selecting balances, technical aspects such as resolution, precision and weighing range must be taken into account, as must special design features. The installation location should be protected from draughts, sunlight and vibrations. The correct functioning of the balance must be regularly checked and documented. A distinction is made between a daily check of the weighing range and, for example, a monthly calibration of the entire operating range. In this excerpt from the GMP Compliance Adviser, you will find answers to the following questions:

What requirements must the installation location of a balance meet?
Which technical aspects and design features must be considered when selecting a balance?
How are the calibration limits determined?

10.06.2021 | ASK OUR EXPERTS

Are there any requirements regarding the microbiological monitoring of sewage drains in production rooms?

Are there any requirements regarding the microbiological monitoring of sewage drains in production rooms?

Should there be a microbiological monitoring program in place specifically for the drains?

First of all, drains in production rooms are not permitted in class A/B (EU GMP Guide, Annex 1 No. 50) which means the question should refer exclusively to production rooms starting with class C. Further information on the construction of drains can be found in EU GMP Guide Part I, 3.11.

07.06.2021 | QUESTION OF THE WEEK

What is an OEL value?

read more ...

01.01.2021 | AUTHOR

Michael Craig

Michael Craig

As a Principal Consultant at PAREXEL Michael Craig helps clients prepare their CTA, marketing authorisation and variation submissions as a CMC Subject Matter Expert and provides regulatory and technical input for lifecycle activities in European and international markets.

16.06.2020 | ASK OUR EXPERTS

Validity period of FDA Certificates of Conformity?

Validity period of FDA Certificates of Conformity?

A manufacturer of pharmaceutical production facilities and containers must provide evidence of FDA conformity of materials in contact with the product, especially sealing materials. This repeatedly leads to discussions within the company about the validity period of corresponding supplier certificates. Is a certificate simply valid until a new certificate is issued because, for example, the material composition has changed? Is a 10-year-old certificate of conformity still valid?

01.06.2020 | AUTHOR

PhD, Dennis Sandkühler

PhD, Dennis Sandkühler

We warmly welcome Dr. Sandkühler to the GMP-BERATER experts team!

21.06.2021 | QUESTION OF THE WEEK

What significance do OEBs have?

read more ...

18.06.2021 | NEWS

FDA presents first global forum for generics

FDA presents first global forum for generics

In early June, the FDA unveiled the Generic Drug Cluster, the first forum for leading regulatory authorities to address the global development of generic drugs.

14.06.2021 | QUESTION OF THE WEEK

What task do code readers have on a packaging line?

read more ...

08.06.2021 | LOGFILE Feature 22/2021

Design Qualification for Premises and Air Handling Units

Design Qualification for Premises and Air Handling Units

7 min. reading time | by Harald Flechl

The design qualification process may vary depending on the project and the client's requirements and may be carried out in two or three design phases.

01.06.2021 | LOGFILE Feature 21/2021

Contract Manufacturing: Technology Transfer Phases

Contract Manufacturing: Technology Transfer Phases

10 minutes reading time | by Chistian Gausepohl, PhD

01.09.2020 | ASK OUR EXPERTS

Late, but not too late? How to best define the final time point of a stability study?

Late, but not too late? How to best define the final time point of a stability study?

01.06.2020 | AUTHOR

Ralf Gengenbach

Ralf Gengenbach

We warmly welcome Dr. Sandkühler to the GMP-BERATER experts team!

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