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26.10.2021 | LOGFILE Feature 40/2021

Non-Sterile Drug Products: Microbial Risks

Non-Sterile Drug Products: Microbial Risks

6 min. reading time | by Sabine Paris, PhD

 

The PDA/FDA Joint Regulatory Conference, which is now in its 30th year, took place as a virtual event from September 27 – September 29. The Conference focused on the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle by vigilantly managing risks to manufacturing and quality.


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25.10.2021 | QUESTION OF THE WEEK

What is an Establishment Inspection Report (EIR)?


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22.10.2021 | NEWS

FDA: Inspectional Observations 2021 published

FDA: Inspectional Observations 2021 published

The FDA’s Office of Regulatory Affairs (ORA), responsible for inspections and other field activities, has released its summary on inspectional observations listed on FDA Forms 483 from October 2020 to September 2021.


read more ...
19.10.2021 | LOGFILE Feature 39/2021

Packaging Material Testing: The Role of Your Suppliers

Packaging Material Testing: The Role of Your Suppliers

7 min. reading time | by André Deister, Sabine Mendel

 

The supplier of the packaging materials plays an important role when pharmaceutical packaging materials undergo testing. Because of the numerous materials involved, the complexity of the manufacturing process and the extremely specific test parameters, many of the packaging material tests are carried out at the supplier.


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18.10.2021 | QUESTION OF THE WEEK

What is a computerised system?


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15.10.2021 | NEWS

USP: General Chapter 1220 of Analytical Procedure Life Cycle pre-published

USP: General Chapter 1220 of Analytical Procedure Life Cycle pre-published

The United States Pharmacopeia has released a new Chapter 1220 on “Analytical Procedure Life Cycle” prior to its official publication and entering into force on 1 May 2022. The chapter considers the validation activities that take place across the entire life cycle of an analytical procedure and provides a framework for the implementation of the life cycle approach.


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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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01.01.2021 | 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 ...
01.06.2020 | AUTHOR

Ralf Gengenbach

Ralf Gengenbach

Ralf Gengenbach founded gempex GmbH in 2002 as managing associate. Gempex GmbH is one of the leading GMP service companies with an international orientation today. The headquarter of gempex is Mannheim, further locations are Sisseln, Switzerland, and Guangzhou, China.


read more ...
26.10.2021 | LOGFILE Feature 40/2021

Non-Sterile Drug Products: Microbial Risks

Non-Sterile Drug Products: Microbial Risks

6 min. reading time | by Sabine Paris, PhD

 

The PDA/FDA Joint Regulatory Conference, which is now in its 30th year, took place as a virtual event from September 27 – September 29. The Conference focused on the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle by vigilantly managing risks to manufacturing and quality.


read more ...
22.10.2021 | NEWS

FDA: Inspectional Observations 2021 published

FDA: Inspectional Observations 2021 published

The FDA’s Office of Regulatory Affairs (ORA), responsible for inspections and other field activities, has released its summary on inspectional observations listed on FDA Forms 483 from October 2020 to September 2021.


read more ...
18.10.2021 | QUESTION OF THE WEEK

What is a computerised system?


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 ...
25.10.2021 | QUESTION OF THE WEEK

What is an Establishment Inspection Report (EIR)?


read more ...
19.10.2021 | LOGFILE Feature 39/2021

Packaging Material Testing: The Role of Your Suppliers

Packaging Material Testing: The Role of Your Suppliers

7 min. reading time | by André Deister, Sabine Mendel

 

The supplier of the packaging materials plays an important role when pharmaceutical packaging materials undergo testing. Because of the numerous materials involved, the complexity of the manufacturing process and the extremely specific test parameters, many of the packaging material tests are carried out at the supplier.


read more ...
15.10.2021 | NEWS

USP: General Chapter 1220 of Analytical Procedure Life Cycle pre-published

USP: General Chapter 1220 of Analytical Procedure Life Cycle pre-published

The United States Pharmacopeia has released a new Chapter 1220 on “Analytical Procedure Life Cycle” prior to its official publication and entering into force on 1 May 2022. The chapter considers the validation activities that take place across the entire life cycle of an analytical procedure and provides a framework for the implementation of the life cycle approach.


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 ...
01.06.2020 | AUTHOR

Ralf Gengenbach

Ralf Gengenbach

Ralf Gengenbach founded gempex GmbH in 2002 as managing associate. Gempex GmbH is one of the leading GMP service companies with an international orientation today. The headquarter of gempex is Mannheim, further locations are Sisseln, Switzerland, and Guangzhou, China.


read more ...

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