Revision of the EU GMP Guide – Annex 2

27 August 2018
active substance, Annex 2, API, biological, EC, GMP, manufacture, medicinal product, revision,

The revised Annex 2: Manufacture of Biological active substances and Medicinal Products for Human Use of the EU GMP Guide came into operation on 26 June 2018. Annex 2 has been revised as a consequence of the adoption of the Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products. The previous version of

Review of common medicines used to treat hypertension – valsartan – due to detection of impurity, N-nitrosodimethylamine (NDMA), a probable human carcinogen! (Part II)

20 August 2018
active substance, API, carcinogen, CEP, distribution, EDQM, EMA, human, hypertension, impurity, manufacturer, manufacturing, medicinal product, medicines, N-nitrosodimethylamine, NDMA, recall, review, stopping, suspension, valsartan, Zhejiang Tianyu,

The company Zhejiang Tianyu is no longer authorised to manufacture the valsartan active substance for EU medicines following the suspension of its CEP – a certificate verifying that the quality of its valsartan meets European requirements. The suspension of the certificate by the European Directorate for the Quality of Medicines and Healthcare (EDQM) comes after

Review of common medicines used to treat hypertension – valsartan – due to detection of impurity, N-nitrosodimethylamine (NDMA), a probable human carcinogen! (Part I)

16 August 2018
active substance, animal test, API, cancer, carcinogen, CEP, change, EDQM, EMA, FDA, final product, formation, health effect, Hetero Labs Limited, human, hypertension, impurity, manufacturer, manufacturing, medicinal product, medicines, N-nitrosodimethylamine, NDMA, OMCL, patient, process, recall, review, risk, safety profile, side product, suspension, valsartan, Zhejiang Huahai Pharmaceuticals, Zhejiang Tianyu,

The European Medicines Agency (EMA) is reviewing medicines containing the active substance valsartan. Valsartan medicines are used to treat patients with high blood pressure in order to reduce complications such as heart attack and stroke. It is also used in patients who have had heart failure or a recent heart attack. It should be noted

Pharmaceutical industry Brexit preparedness and its legal consequences for MAH

13 November 2017
API, batch release, Brexit, CMDh, CMDv, CP, DCP, EC, EMA, finished product, GMP, impact, import, legal consequences, MA, MAH, manufacture, marketing authorisation, marketing authorisation holder, medicinal products, MRP, notice, QPPV, RMS, site, transfer, UK's withdrawal, variation,

On 2 May 2017, the European Commission and EMA published a Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use, stating: “The United Kingdom submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union.

(Q)SAR models – important tool of risk assessment to support practical implementation of ICH M7 guideline

29 September 2017
(Q)SAR, genotoxic impurities, GTIs, ICH M7, mutagenic impurities, mutagenicity assay, mutagenicity prediction, qsar validation principles, qualification of impurities,

A general concept of qualification of impurities (or degradation products) is described in the ICH Q3A/B guidelines, whereby qualification is defined as the process of acquiring and evaluating data that establishes the biological safety of an individual impurity (or degradation product) or a given impurity (or degradation) profile at the level(s) specified. Therefore to limit

EMA published Guideline on process validation (PV) for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission

18 July 2016

On 29 April 2016, EMA published a new document entitled Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission. The new guideline will become effective on 1 November 2016. It should be noted that the need to develop guidance on process validation of biotechnology

EMA published a Draft guideline on the sterilisation of the medicinal product, active substance, excipient and primary container (Part I)

29 June 2016
Annex 1, API, aseptic processing, excipients, filtration, finished dosage form, GMP, medicinal product, primary container, SAL, sterilisation, sterilisation assurance level, sterility, terminal sterilisation,

On 13 April 2016, EMA released for 6 months public consultation the Draft guideline on the sterilisation of the medicinal product, active substance, excipient and primary container. A new guidance is developed as a separate guidance document and will replace Decision trees for the selection of sterilisation methods (CPMP/QWP/054/98) and Decision trees for the selection

Definition of a New Active Substance (NAS) for chemical substances

1 March 2016

On 19 January 2016, the European Medicines Agency published a new document entitled Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances. This document is intended to reflect the current experience concerning the definition of a New Active Substance (NAS)

Active substance starting material(s) – importance of selection

4 December 2014
active substance, API, cell banks, cell substrate, GMP, ICH Q11, Master Cell Bank, MCB, redefinition, starting material, WCB, Working Cell Bank,

According to the Part II: Basic Requirements for Active Substances used as Starting Materials of the EU GMP Guide, the manufacturer should designate and document the rationale for the point at which production of the active substance begins. For synthetic processes, production of the active substance begins at the point at which “Active Substance Starting

Audits of the manufacturers and distributors of active substances – Legal basis

29 September 2014

According to an Article 46(f) of Directive 2001/83/EC as amended for medicinal products for human use, the holder of a manufacturing authorization shall at least be obliged: “to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with