GMP:Blog

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11.05.2021 | LOGFILE Feature 18/2021

Innovations in Pharmaceutical Manufacturing

Innovations in Pharmaceutical Manufacturing

8 minutes reading time | by Thomas Peither

Were you able to follow the PDA Annual Meeting of the Parenteral Drug Association this year? Or were you like many others who spent the whole day with web meetings and have no time or mood for more online conferences?

10.05.2021 | QUESTION OF THE WEEK

What are the powers of the GMP inspectors in inspections?

read more ...

07.05.2021 | NEWS

ICH: ICH Q3C(R8) Guideline for Residual Solvents contains new PDEs

ICH: ICH Q3C(R8) Guideline for Residual Solvents contains new PDEs

ICH published the revised version (Step 4) of the ICH Q3C(R8) Guideline on Impurities: Guideline for Residual Solvents on 22 April 2021.

04.05.2021 | LOGFILE Feature 17/2021

European Safety Referral: Short and Crisp

European Safety Referral: Short and Crisp

4 minutes reading time | by Michael Hiob, PhD and Sabine Paris, PhD

A referral is a procedure used to resolve concerns over the safety, efficacy or quality of a medicinal product (or a class of medicines). In a referral, the EMA is requested to conduct a scientific assessment of the products in question on behalf of the European Union (EU).

03.05.2021 | QUESTION OF THE WEEK

What is confirmed by the written confirmation for imported APIs?

read more ...

29.04.2021 | NEWS

PIC/S: Revision of the PIC/S GMP Guide PE 009-15

PIC/S: Revision of the PIC/S GMP Guide PE 009-15

As announced by PIC/S on 23 April, 2021, the PIC/S GMP Guide has been revised. The changes will take effect on 1 May 2021.

27.04.2021 | LOGFILE Feature 18/2021

The GMP:Blog is online!

The GMP:Blog is online!

The time has come, the curtain goes up! Now your brand-new online journal is launched.
Let the newly designed GMP:Blog support you in the work with GMP.

26.04.2021 | QUESTION OF THE WEEK

What information is required for the registration of any manufacturers, importers and distributors of active substances in the EU?

read more ...

16.04.2021 | NEWS

FDA:New Guidance on remote interactive inspections

FDA:New Guidance on remote interactive inspections

On 14 April 2021 the US FDA has published a new guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency”. This in fact was long overdue. It outlines

how remote interactive evaluations will be requested by the FDA and
how they will be conducted for the duration of the COVID-19 pandemic.

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.

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?

16.06.2020 | ASK OUR EXPERTS

Validity period of FDA Certificates of Conformity?

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?

01.06.2020 | AUTHOR

Ralf Gengenbach

Ralf Gengenbach

We warmly welcome Dr. Sandkühler to the GMP-BERATER experts team!

01.06.2020 | AUTHOR

PhD, Dennis Sandkühler

PhD, Dennis Sandkühler

We warmly welcome Dr. Sandkühler to the GMP-BERATER experts team!

12.03.2019 | ASK OUR EXPERTS

Is monitoring (of germs and particles) required in “unclean airlock areas” for non-sterile production?

Is monitoring (of germs and particles) required in “unclean airlock areas” for non-sterile production?

The subscribers of our GMP Compliance Adviser, the world’s most comprehensive GMP online knowledge, have the unique opportunity to get answers to those GMP questions that cannot be resolved within their company or that need additional expert advice.

In today`s feature, we answer a question on the need for monitoring in “unclean airlock areas” for non-sterile production. Read about the intriguing and heterogenous answers of our experts.

11.05.2021 | LOGFILE Feature 18/2021

Innovations in Pharmaceutical Manufacturing

Innovations in Pharmaceutical Manufacturing

8 minutes reading time | by Thomas Peither

Were you able to follow the PDA Annual Meeting of the Parenteral Drug Association this year? Or were you like many others who spent the whole day with web meetings and have no time or mood for more online conferences?

07.05.2021 | NEWS

ICH: ICH Q3C(R8) Guideline for Residual Solvents contains new PDEs

ICH: ICH Q3C(R8) Guideline for Residual Solvents contains new PDEs

ICH published the revised version (Step 4) of the ICH Q3C(R8) Guideline on Impurities: Guideline for Residual Solvents on 22 April 2021.

03.05.2021 | QUESTION OF THE WEEK

What is confirmed by the written confirmation for imported APIs?

read more ...

27.04.2021 | LOGFILE Feature 18/2021

The GMP:Blog is online!

The GMP:Blog is online!

The time has come, the curtain goes up! Now your brand-new online journal is launched.
Let the newly designed GMP:Blog support you in the work with GMP.

16.04.2021 | NEWS

FDA:New Guidance on remote interactive inspections

FDA:New Guidance on remote interactive inspections

On 14 April 2021 the US FDA has published a new guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency”. This in fact was long overdue. It outlines

how remote interactive evaluations will be requested by the FDA and
how they will be conducted for the duration of the COVID-19 pandemic.

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?

01.06.2020 | AUTHOR

Ralf Gengenbach

Ralf Gengenbach

We warmly welcome Dr. Sandkühler to the GMP-BERATER experts team!

12.03.2019 | ASK OUR EXPERTS

Is monitoring (of germs and particles) required in “unclean airlock areas” for non-sterile production?

Is monitoring (of germs and particles) required in “unclean airlock areas” for non-sterile production?

The subscribers of our GMP Compliance Adviser, the world’s most comprehensive GMP online knowledge, have the unique opportunity to get answers to those GMP questions that cannot be resolved within their company or that need additional expert advice.

In today`s feature, we answer a question on the need for monitoring in “unclean airlock areas” for non-sterile production. Read about the intriguing and heterogenous answers of our experts.

10.05.2021 | QUESTION OF THE WEEK

What are the powers of the GMP inspectors in inspections?

read more ...

04.05.2021 | LOGFILE Feature 17/2021

European Safety Referral: Short and Crisp

European Safety Referral: Short and Crisp

4 minutes reading time | by Michael Hiob, PhD and Sabine Paris, PhD

A referral is a procedure used to resolve concerns over the safety, efficacy or quality of a medicinal product (or a class of medicines). In a referral, the EMA is requested to conduct a scientific assessment of the products in question on behalf of the European Union (EU).

29.04.2021 | NEWS

PIC/S: Revision of the PIC/S GMP Guide PE 009-15

PIC/S: Revision of the PIC/S GMP Guide PE 009-15

As announced by PIC/S on 23 April, 2021, the PIC/S GMP Guide has been revised. The changes will take effect on 1 May 2021.

26.04.2021 | QUESTION OF THE WEEK

What information is required for the registration of any manufacturers, importers and distributors of active substances in the EU?

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.

16.06.2020 | ASK OUR EXPERTS

Validity period of FDA Certificates of Conformity?

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?

01.06.2020 | AUTHOR

PhD, Dennis Sandkühler

PhD, Dennis Sandkühler

We warmly welcome Dr. Sandkühler to the GMP-BERATER experts team!

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