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News about GMP/cGMP

2018-06-15

The US FDA is currently alerting patients, health care professionals and those involved in the drug supply chain of more than 16,000 packages of the injectable fertility medications Gonal-f RFF Redi-ject and Gonal-f Multi-Dose that have been stolen in Italy.

 
2018-06-15

With the publication of the 52nd Technical Report Series No. 1010 of the WHO, eleven Guidelines were adopted and recommended for use:

 
2018-06-08

The ICH Q3D(R1) Revision of the ICH Q3D Guideline for Elemental Impurities reached Step 2b of the ICH Process in May 2018 and now enters the consultation period. The revision is focused on an error correction in the calculation of the Cadmium inhalation Permitted Daily Exposure (PDE) level.

 
2018-06-08

The US Food and Drug Administration (FDA) confirmed the capability of Lithuania and Ireland to carry out GMP inspections at a level equivalent to the US.

 
2018-06-06

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.
 
2018-06-01

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.

 
2018-05-22

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.

 
2018-05-14

From 16 to 18 April 2018 the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.

 
2018-05-14

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.

 
2018-05-02

On Tuesday, 27/4/2018, MHRA (Medicines and Healthcare products Regulatory Agency) published is five-year Corporate Plan for 2018 - 2023.

 
2018-05-02

The European Medicines Agency (EMA) and the Netherlands have finalised the text of a Seat Agreement which describes how the Agency, its bodies and its employees will be treated by the Dutch once they start operating in the Netherlands.

 
2018-05-02

On 30 April 2018, the EMA published the final, revised version of the Q&A document with its focus on setting health-based exposure limits for risk identification and the risk-based prevention of cross-contamination. The Q&A covers 13 questions and answers relating to the “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”, which has been in force since June 2015.

In January 2017, the EMA released a draft for public consultation (we reported). But this paper constituted a roll backwards!
 
2018-04-20

The FDA (US Food and Drug Administration) finalised the ICH Q7 Q&A Guidance on GMPs for APIs on Thursday April 19, 2018.

 
2018-04-20

Almost one year ago, the ICH published its Guideline for Residual Solvents in the version ICH Q3C (R6) introducing new PDE-Levels for Triethylamine and Methylisobutylketone.
Currently, this Guideline is again undergoing maintenance, which shall result in the future Q3C(R7) version, to develop PDE levels for the following three solvents:

 
2018-04-20

In July 2016, the Pharmaceuticals and Medical Devices Agency (PMDA) established the Innovative Manufacturing Technology Working Group (IMT-WG) as part of the “Projects Across Multi-Offices” in PMDA. The IMT-WG launched activities to examine desirable regulations that streamline the introduction of new manufacturing technologies, and selected continuous manufacturing as their primary target.

 
 
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