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18.10.2021 | QUESTION OF THE WEEK

What is a computerised system?


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15.10.2021 | NEWS

USP: General Chapter 1220 of Analytical Procedure Life Cycle pre-published

USP: General Chapter 1220 of Analytical Procedure Life Cycle pre-published

The United States Pharmacopeia has released a new Chapter 1220 on “Analytical Procedure Life Cycle” prior to its official publication and entering into force on 1 May 2022. The chapter considers the validation activities that take place across the entire life cycle of an analytical procedure and provides a framework for the implementation of the life cycle approach.


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15.10.2021 | NEWS

EC: Proposal for progressive introduction of IVDR

EC: Proposal for progressive introduction of IVDR

On 14 October 2021, the European Commission has proposed a “progressive roll-out” of the upcoming In Vitro Diagnostic Medical Devices Regulation, IVDR. The reason given for that is to prevent disruption in the supply of those essential healthcare products that fall under it, as well as a serious shortage of notified body capacity. The IVDR was planned to apply as of 26 May 2022.


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12.10.2021 | LOGFILE Feature 38/2021

What’s new for ICH Q9 and ICH Q12?

What’s new for ICH Q9 and ICH Q12?

7 min. reading time | by Sabine Paris, PhD

 

The PDA/FDA Joint Regulatory Conference, which is now in its 30th year, took place as a virtual event from September 27 – September 29. The Conference focused on the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle by vigilantly managing risks to manufacturing and quality.


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11.10.2021 | QUESTION OF THE WEEK

What are the most important QMS areas of a GMP inspection?


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05.10.2021 | LOGFILE Feature 37/2021

Defect Evaluation Lists and Defect Pattern Libraries Create them yourself – but how?

Defect Evaluation Lists and Defect Pattern Libraries Create them yourself – but how?

7 min. reading time | by Felix Tobias Kern, PhD, and Fritz Röder

 

Defect evaluation lists and defect pattern libraries are popular GMP documents that have been used for more than 45 years. They serve as a rationale for the quality assessment of individual batches and set quality standards for the manufacture and testing of pharmaceutical products.


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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.


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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.


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01.06.2020 | AUTHOR

Ralf Gengenbach

Ralf Gengenbach

Ralf Gengenbach founded gempex GmbH in 2002 as managing associate. Gempex GmbH is one of the leading GMP service companies with an international orientation today. The headquarter of gempex is Mannheim, further locations are Sisseln, Switzerland, and Guangzhou, China.


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18.10.2021 | QUESTION OF THE WEEK

What is a computerised system?


read more ...
15.10.2021 | NEWS

EC: Proposal for progressive introduction of IVDR

EC: Proposal for progressive introduction of IVDR

On 14 October 2021, the European Commission has proposed a “progressive roll-out” of the upcoming In Vitro Diagnostic Medical Devices Regulation, IVDR. The reason given for that is to prevent disruption in the supply of those essential healthcare products that fall under it, as well as a serious shortage of notified body capacity. The IVDR was planned to apply as of 26 May 2022.


read more ...
11.10.2021 | QUESTION OF THE WEEK

What are the most important QMS areas of a GMP inspection?


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.


read more ...
15.10.2021 | NEWS

USP: General Chapter 1220 of Analytical Procedure Life Cycle pre-published

USP: General Chapter 1220 of Analytical Procedure Life Cycle pre-published

The United States Pharmacopeia has released a new Chapter 1220 on “Analytical Procedure Life Cycle” prior to its official publication and entering into force on 1 May 2022. The chapter considers the validation activities that take place across the entire life cycle of an analytical procedure and provides a framework for the implementation of the life cycle approach.


read more ...
12.10.2021 | LOGFILE Feature 38/2021

What’s new for ICH Q9 and ICH Q12?

What’s new for ICH Q9 and ICH Q12?

7 min. reading time | by Sabine Paris, PhD

 

The PDA/FDA Joint Regulatory Conference, which is now in its 30th year, took place as a virtual event from September 27 – September 29. The Conference focused on the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle by vigilantly managing risks to manufacturing and quality.


read more ...
05.10.2021 | LOGFILE Feature 37/2021

Defect Evaluation Lists and Defect Pattern Libraries Create them yourself – but how?

Defect Evaluation Lists and Defect Pattern Libraries Create them yourself – but how?

7 min. reading time | by Felix Tobias Kern, PhD, and Fritz Röder

 

Defect evaluation lists and defect pattern libraries are popular GMP documents that have been used for more than 45 years. They serve as a rationale for the quality assessment of individual batches and set quality standards for the manufacture and testing of pharmaceutical products.


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.


read more ...
01.06.2020 | AUTHOR

Ralf Gengenbach

Ralf Gengenbach

Ralf Gengenbach founded gempex GmbH in 2002 as managing associate. Gempex GmbH is one of the leading GMP service companies with an international orientation today. The headquarter of gempex is Mannheim, further locations are Sisseln, Switzerland, and Guangzhou, China.


read more ...

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