Posted: June 06, 2018||
In May the US FDA has issued five Warning Letters that address cGMP-violations on a large scale. The drug facilities involved are:
- Jilin Shulan Synthetic Pharmaceutical und Nox Bellcow Cosmetics Co, China
- Jalco Cosmetics, Australia
- Europharma Concepts, Ireland
- Reine Lifescience, India.
Posted: June 01, 2018||
On 23 May 2018, the European Medicines Agency (EMA) released a guideline laying out the principles for managing investigational medicinal products for use in a clinical trial and in accordance with Good Clinical Practices (GCPs) and Good Manufacturing Practice (GMPs) for public consultation.
Posted: May 23, 2018||
Practical Issues on Supply Chain and Good Distribution Practice
A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2017
6 minutes reading time
by Susanne Sailer
Posted: May 22, 2018||
The UK government must secure a post-Brexit deal for the pharmaceutical industry that ensures the closest possible regulatory alignment with the EU and the minimum border friction possible or risk harming patients and seeing the pharma sector losing its status as a world leader, say the Business, Energy and Industrial Strategy Committee of the UK parliament.
Posted: May 18, 2018|Categories: GMP Compliance Adviser Updates|
With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:
14.N Determining and reporting numerical test results in pharmaceutical quality control 15.D Standard Operating Procedures (SOPs) C.5 EU GMP Guide Part II: Basic Requirements for Active Substances used as Starting Materials combined with GMP for APIs: “How to do“ Document by APIC/CEFIC Interpretation of the ICH Q7 Guide C.8.6.1 Questions and answers on implementation of risk-based prevention of cross-contamination in production and ‘Guideline on setting healthbased exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP/CVMP/ SWP/169430/2012)
Posted: May 16, 2018||
2017 – The GMP Regulations Report
by Sabine Rabus
Posted: May 14, 2018||
The Danish Medicines Agency recently met with representatives from the Japanese Ministry of Health, Labour and Welfare (MHLW), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in Copenhagen.
From 16 to 18 April 2018 the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.
Posted: May 09, 2018||
The Never-Ending Story of Annex 1 and the Obstacles of Aseptic Processing
A report on the ISPE European Annual Meeting 2018
8 minutes reading time
by Thomas Peither
Posted: May 02, 2018||