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On 18 April, the EMA launched a new draft version of the Guideline on Good Agricultural and Collection Practice (GACP) for for starting materials of herbal origin.
This update brings the document up to date with current standards, incorporates the increased development of indoor growing technologies and also covers best practice and legal interpretations published over the last 10 years.
7 min. reading time | by Birte Scharf, PhD
Advanced therapy medicinal products (ATMPs) are an innovative class of medicinal products characterised by the use of advanced technologies.They target the underlying genetic, cellular, or tissue-based abnormalities of diseases and thus offer the potential for cure or at least a long-term therapeutic benefit.
Authors from A to Z: Find an alphabetical list of our authors in the GMP Compliance Adviser. Click here!
On 10 April, the EU Parliament approved a legislative package to reform the EU‘s pharmaceutical legislation, with the aim of boosting innovation and improving the accessibility and affordability of medicines. The package, which includes a new directive and a regulation, recieved strong support from Members of the European Parliament (MEPs).
10 min. reading time | by Thomas Peither
When I worked on the first GMP projects as a consultant in 1994, the internet was still in its infancy. Getting an official copy of 21 CFR 210/211 was more than a hassle. You had to send a written request to the USA and after weeks, a barely legible copy would arrive by post.
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.
"What is the best procedure for selecting samples from a stability chamber in the final test interval of ongoing stability tests?"
7 min. reading time | by Birte Scharf, PhD
Advanced therapy medicinal products (ATMPs) are an innovative class of medicinal products characterised by the use of advanced technologies.They target the underlying genetic, cellular, or tissue-based abnormalities of diseases and thus offer the potential for cure or at least a long-term therapeutic benefit.
Authors from A to Z: Find an alphabetical list of our authors in the GMP Compliance Adviser. Click here!
10 min. reading time | by Thomas Peither
When I worked on the first GMP projects as a consultant in 1994, the internet was still in its infancy. Getting an official copy of 21 CFR 210/211 was more than a hassle. You had to send a written request to the USA and after weeks, a barely legible copy would arrive by post.
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.
On 18 April, the EMA launched a new draft version of the Guideline on Good Agricultural and Collection Practice (GACP) for for starting materials of herbal origin.
This update brings the document up to date with current standards, incorporates the increased development of indoor growing technologies and also covers best practice and legal interpretations published over the last 10 years.
On 10 April, the EU Parliament approved a legislative package to reform the EU‘s pharmaceutical legislation, with the aim of boosting innovation and improving the accessibility and affordability of medicines. The package, which includes a new directive and a regulation, recieved strong support from Members of the European Parliament (MEPs).
"What is the best procedure for selecting samples from a stability chamber in the final test interval of ongoing stability tests?"