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18.01.2022 | LOGFILE Feature 02/2022

The GMP Regulations Report 2021

The GMP Regulations Report 2021

13 min. reading time | shortened version

 

From a regulatory perspective, the year 2021 had plenty in store. Parallel to the omnipresent COVID-19 pandemic, the authorities around the world managed to finalize draft documents that became “sideshows” while the pandemic took centre stage. What topics kept the GMP professionals on their toes?


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17.01.2022 | QUESTION OF THE WEEK

What are the 3 designs for counterfeit-proof features?


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14.01.2022 | NEWS

Amendment of Delegated Regulation (EU) on Safety Features

Amendment of Delegated Regulation (EU) on Safety Features

Already in March last year, an adaption of the Delegated Regulation (EU) 2016/161 on safety features allowed a temporary derogation of the obligation for wholesalers to deactivate the individual identifier (IE) of medicinal products exported to the UK - as a third country (we reported). This exemption was granted for the year 2021.


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11.01.2022 | LOGFILE Feature 01/2022

How to Maintain the Qualification Status of Your Equipment

How to Maintain the Qualification Status of Your Equipment

8 min. reading time |

 

The life cycle of an equipment begins with initial qualification and ends with decommissioning. Once a qualification status has been achieved, it must be guaranteed over the entire life cycle until the equipment is decommissioned. This is ensured by regular calibration, maintenance, effective change management and periodic review.


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10.01.2022 | QUESTION OF THE WEEK

What is a stability commitment?


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07.01.2022 | NEWS

EC: Updated Q&A on Safety Features, Version 19

EC: Updated Q&A on Safety Features, Version 19

The European Commission published Version 19 of the Q&A on safety features for medicinal products in late December 2021.

What's new?

  • Question 1.29: Do the unique identifiers of reference and retention samples taken from stock in compliance with Annex 19 of the EU GMP Guidelines5 and uploaded to the EMVS have to be decommissioned? If yes, to what status?
    Answer: Yes, if a sample of a batch is taken as reference or retention sample after uploading in EMVS, it should be decommissioned as "sample". If a sample is taken voluntarily by a wholesaler that fall outside the scope of Annex 19, they should be decommissioned as "destroyed".

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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.


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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?

read more ...
18.01.2022 | LOGFILE Feature 02/2022

The GMP Regulations Report 2021

The GMP Regulations Report 2021

13 min. reading time | shortened version

 

From a regulatory perspective, the year 2021 had plenty in store. Parallel to the omnipresent COVID-19 pandemic, the authorities around the world managed to finalize draft documents that became “sideshows” while the pandemic took centre stage. What topics kept the GMP professionals on their toes?


read more ...
14.01.2022 | NEWS

Amendment of Delegated Regulation (EU) on Safety Features

Amendment of Delegated Regulation (EU) on Safety Features

Already in March last year, an adaption of the Delegated Regulation (EU) 2016/161 on safety features allowed a temporary derogation of the obligation for wholesalers to deactivate the individual identifier (IE) of medicinal products exported to the UK - as a third country (we reported). This exemption was granted for the year 2021.


read more ...
10.01.2022 | QUESTION OF THE WEEK

What is a stability commitment?


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 ...
17.01.2022 | QUESTION OF THE WEEK

What are the 3 designs for counterfeit-proof features?


read more ...
11.01.2022 | LOGFILE Feature 01/2022

How to Maintain the Qualification Status of Your Equipment

How to Maintain the Qualification Status of Your Equipment

8 min. reading time |

 

The life cycle of an equipment begins with initial qualification and ends with decommissioning. Once a qualification status has been achieved, it must be guaranteed over the entire life cycle until the equipment is decommissioned. This is ensured by regular calibration, maintenance, effective change management and periodic review.


read more ...
07.01.2022 | NEWS

EC: Updated Q&A on Safety Features, Version 19

EC: Updated Q&A on Safety Features, Version 19

The European Commission published Version 19 of the Q&A on safety features for medicinal products in late December 2021.

What's new?

  • Question 1.29: Do the unique identifiers of reference and retention samples taken from stock in compliance with Annex 19 of the EU GMP Guidelines5 and uploaded to the EMVS have to be decommissioned? If yes, to what status?
    Answer: Yes, if a sample of a batch is taken as reference or retention sample after uploading in EMVS, it should be decommissioned as "sample". If a sample is taken voluntarily by a wholesaler that fall outside the scope of Annex 19, they should be decommissioned as "destroyed".

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 ...
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?

read more ...

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