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23.05.2022 | QUESTION OF THE WEEK

What formal aspects help to improve the readability of SOPs?


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20.05.2022 | NEWS

FDA: Revised Guideline on OOS Results

FDA: Revised Guideline on OOS Results

The US FDA has revised its 16-year-old guidance on how to investigate out-of-specification (OOS) test results in laboratories. The document includes all necessary steps to be taken when investigating OOS test results. It also considers the responsibilities of the analyst and the laboratory supervisor in case of OOS results being identified, along with additional testing steps and a final evaluation of all results.


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20.05.2022 | NEWS

ICH: Final Q3D (R2) Guideline on Elemental Impurities

ICH: Final Q3D (R2) Guideline on Elemental Impurities

ICH Q3D (R2) has reached Step 4 of the ICH-Process and will now be distributed to the Member States for implementation. The revision (R2) focused on

  • the establishment of limits for elemental impurities by the dermal route of exposure, summarized in a new Appendix 5 Limits for Elemental Impurities by the Cutaneous and Transcutaneous Route
  • and error corrections of the PDEs for Silver (oral), Gold (oral, parenteral and inhalation) and Nickel (inhalation).

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17.05.2022 | LOGFILE Feature 19/2022

Initial Classification of a Commercial Return (CR) by the CR Coordinator

Initial Classification of a Commercial Return (CR) by the CR Coordinator

7 min. reading time | by Alexandra Fürst

 


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16.05.2022 | QUESTION OF THE WEEK

Which parameters determine the result of cleaning according to Sinner's circle?


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03.05.2022 | LOGFILE Feature 17/2022

CAPA Systems: Autonomous or Integrated?

CAPA Systems: Autonomous or Integrated?

8 min. reading time | by Thomas Peither

 

A CAPA system should be understood as an important element of the pharmaceutical quality system and implemented uniformly throughout the company or group. In principle, it can be implemented in two different ways: as an autonomous or as an integrated system.


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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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01.06.2021 | AUTHOR

Petra Berlemann

Petra Berlemann

Petra Berlemann has been working in various areas of quality management since 2007.


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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.


read more ...
23.05.2022 | QUESTION OF THE WEEK

What formal aspects help to improve the readability of SOPs?


read more ...
20.05.2022 | NEWS

ICH: Final Q3D (R2) Guideline on Elemental Impurities

ICH: Final Q3D (R2) Guideline on Elemental Impurities

ICH Q3D (R2) has reached Step 4 of the ICH-Process and will now be distributed to the Member States for implementation. The revision (R2) focused on

  • the establishment of limits for elemental impurities by the dermal route of exposure, summarized in a new Appendix 5 Limits for Elemental Impurities by the Cutaneous and Transcutaneous Route
  • and error corrections of the PDEs for Silver (oral), Gold (oral, parenteral and inhalation) and Nickel (inhalation).

read more ...
16.05.2022 | QUESTION OF THE WEEK

Which parameters determine the result of cleaning according to Sinner's circle?


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 ...
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 ...
20.05.2022 | NEWS

FDA: Revised Guideline on OOS Results

FDA: Revised Guideline on OOS Results

The US FDA has revised its 16-year-old guidance on how to investigate out-of-specification (OOS) test results in laboratories. The document includes all necessary steps to be taken when investigating OOS test results. It also considers the responsibilities of the analyst and the laboratory supervisor in case of OOS results being identified, along with additional testing steps and a final evaluation of all results.


read more ...
17.05.2022 | LOGFILE Feature 19/2022

Initial Classification of a Commercial Return (CR) by the CR Coordinator

Initial Classification of a Commercial Return (CR) by the CR Coordinator

7 min. reading time | by Alexandra Fürst

 


read more ...
03.05.2022 | LOGFILE Feature 17/2022

CAPA Systems: Autonomous or Integrated?

CAPA Systems: Autonomous or Integrated?

8 min. reading time | by Thomas Peither

 

A CAPA system should be understood as an important element of the pharmaceutical quality system and implemented uniformly throughout the company or group. In principle, it can be implemented in two different ways: as an autonomous or as an integrated system.


read more ...
01.06.2021 | AUTHOR

Petra Berlemann

Petra Berlemann

Petra Berlemann has been working in various areas of quality management since 2007.


read more ...

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