23.05.2022
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QUESTION OF THE WEEK
GMP:Blog
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20.05.2022
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NEWS
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 ...
20.05.2022
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NEWS
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 ...
17.05.2022
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LOGFILE Feature 19/2022
Initial Classification of a Commercial Return (CR) by the CR Coordinator
16.05.2022
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QUESTION OF THE WEEK
03.05.2022
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LOGFILE Feature 17/2022
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 ...
10.06.2021
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ASK OUR EXPERTS
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
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AUTHOR
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 ...
01.09.2020
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ASK OUR EXPERTS
Late, but not too late? How to best define the final time point of a stability study?
23.05.2022
|
QUESTION OF THE WEEK
20.05.2022
|
NEWS
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
10.06.2021
|
ASK OUR EXPERTS
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
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
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
03.05.2022
|
LOGFILE Feature 17/2022
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 ...
01.09.2020
|
ASK OUR EXPERTS
Late, but not too late? How to best define the final time point of a stability study?