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!

Read the information that is important to you!

This is how it works: Use the drop-down fields to filter the information type, your subject area and the year of publication. You would like to decide even faster which type of information to be displayed to you? Then simply click on the graphics!


Filter Articles: 
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?


read more ...
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.


read more ...
29.01.2019 | ASK OUR EXPERTS

When and how must OOS examinations be triggered?

When and how must OOS examinations be triggered?

This time we answer questions on the triggering of OOS investigations with information from the GMP Compliance Adviser and further statements by a GMP inspector and a quality unit manager. As a LOGFILE subscriber, you too will be kept up to date and at the same time gain an insight into the diverse activities of our editorial team.


read more ...
08.01.2019 | ASK OUR EXPERTS

Who may carry out the sampling?

Who may carry out the sampling?

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 practical implementation of the sampling of medicinal products and active substances. Who can do that? Sampling affects all areas of pharmaceutical production and is an important basis for quality decisions.


read more ...
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.


read more ...
08.01.2019 | ASK OUR EXPERTS

Who may carry out the sampling?

Who may carry out the sampling?

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 practical implementation of the sampling of medicinal products and active substances. Who can do that? Sampling affects all areas of pharmaceutical production and is an important basis for quality decisions.


read more ...
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?


read more ...
29.01.2019 | ASK OUR EXPERTS

When and how must OOS examinations be triggered?

When and how must OOS examinations be triggered?

This time we answer questions on the triggering of OOS investigations with information from the GMP Compliance Adviser and further statements by a GMP inspector and a quality unit manager. As a LOGFILE subscriber, you too will be kept up to date and at the same time gain an insight into the diverse activities of our editorial team.


read more ...

Would you like to read more articles?

Use our useful filter tool!