02.08.2021
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QUESTION OF THE WEEK
GMP:Blog
Here you find current and comprehensive information about Good Manufacturing Practice. Whether mobile phone, tablet or laptop - with the GMP:Blog you stay up to date no matter where you are!
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30.07.2021
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NEWS
ICH: ICH-Q13 Draft on Continuous Manufacturing released
On 27 July 2021, ICH published the anticipated draft of its Q13 Guideline on Continuous Manufacturing of Drug Substances & Drug Products. In Stage 2 of the ICH process the 44-page document has thus been released for public commentation.
The guideline is intended to provide "scientific and legal considerations for the design, implementation, operation and lifecycle management of continuous manufacturing (CM)".
read more ...
27.07.2021
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LOGFILE Feature 29/2021
Practical implementation of the PQS
9 min. reading time | by Stephanie Blum
In addition to the preceding general statements on the PQS, Chapter 1 of the EU GMP Guidelines contains specific information on GMP for medicinal products and quality control.
read more ...
26.07.2021
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QUESTION OF THE WEEK
23.07.2021
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NEWS
FDA: Push for more authority on device shortages
As part of the annual budget planning acting FDA Commissioner Janet Woodcock has addressed the problem of weaknesses in the medical devices supply chain and its overall dependence on foreign medical devices.
read more ...
20.07.2021
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NEWS
PIC/S: Guidance on Risk Assesment of Routine on-Site Inspections with COVID 19
PIC/S published a new guidance COVID-19 Risk Assessment for Routine On-Site Inspections” (PI 055-1) which entered into force on 15 July 2021.
The guidance is addressed to inspectors and covers the actions to be taken during the planning phase of an inspection, in consultation with the site to be inspected.
read more ...
20.07.2021
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LOGFILE Feature 28/2021
GMP Inspections: Organisation of the Front and Back Office
9 min. reading time | by Thomas Peither
The inspection is carried out in the front office and prepared in the back office. The preparation room is used to train and instruct staff.
read more ...
19.07.2021
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QUESTION OF THE WEEK
14.07.2021
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LOGFILE Feature 27/2021
Qualification Master Plan: Regulatory Requirements
11 min. reading time | by Thomas Peither
A definition of the term “qualification master plan (QMP)“ is not to be found in the GMP guidelines, only the term “validation master plan (VMP)”, which serves as a parent document.
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?
16.06.2020
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ASK OUR EXPERTS
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?
read more ...
02.08.2021
|
QUESTION OF THE WEEK
27.07.2021
|
LOGFILE Feature 29/2021
Practical implementation of the PQS
9 min. reading time | by Stephanie Blum
In addition to the preceding general statements on the PQS, Chapter 1 of the EU GMP Guidelines contains specific information on GMP for medicinal products and quality control.
read more ...
23.07.2021
|
NEWS
FDA: Push for more authority on device shortages
As part of the annual budget planning acting FDA Commissioner Janet Woodcock has addressed the problem of weaknesses in the medical devices supply chain and its overall dependence on foreign medical devices.
read more ...
20.07.2021
|
LOGFILE Feature 28/2021
GMP Inspections: Organisation of the Front and Back Office
9 min. reading time | by Thomas Peither
The inspection is carried out in the front office and prepared in the back office. The preparation room is used to train and instruct staff.
read more ...
14.07.2021
|
LOGFILE Feature 27/2021
Qualification Master Plan: Regulatory Requirements
11 min. reading time | by Thomas Peither
A definition of the term “qualification master plan (QMP)“ is not to be found in the GMP guidelines, only the term “validation master plan (VMP)”, which serves as a parent document.
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 ...
16.06.2020
|
ASK OUR EXPERTS
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?
read more ...
30.07.2021
|
NEWS
ICH: ICH-Q13 Draft on Continuous Manufacturing released
On 27 July 2021, ICH published the anticipated draft of its Q13 Guideline on Continuous Manufacturing of Drug Substances & Drug Products. In Stage 2 of the ICH process the 44-page document has thus been released for public commentation.
The guideline is intended to provide "scientific and legal considerations for the design, implementation, operation and lifecycle management of continuous manufacturing (CM)".
read more ...
26.07.2021
|
QUESTION OF THE WEEK
20.07.2021
|
NEWS
PIC/S: Guidance on Risk Assesment of Routine on-Site Inspections with COVID 19
PIC/S published a new guidance COVID-19 Risk Assessment for Routine On-Site Inspections” (PI 055-1) which entered into force on 15 July 2021.
The guidance is addressed to inspectors and covers the actions to be taken during the planning phase of an inspection, in consultation with the site to be inspected.
read more ...
19.07.2021
|
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 ...
01.09.2020
|
ASK OUR EXPERTS
Late, but not too late? How to best define the final time point of a stability study?