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

Revision of the EU GMP Guide – Annex 17 (Part II)

23 August 2018
Annex 17, batch, CAPA, change, CoA, control, control strategy, decision, deviation, EC, finished product, GMP, MA, parametric release, PAT, pharmaceutical development, PQS, predictor, program, QbD, QRM, release, RTRT, strategy,

Recently, the European Commission published a revised version of Annex 17: Real Time Release Testing and Parametric Release of the EU GMP Guide. The new annex will come into operation on 26 December 2018. We have already informed on our website about a consultation document on Annex 17: Real Time Release Testing, published by European

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

GMP for Advanced Therapy Medicinal Products (ATMPs) (Part II) and hospital exemption (HE)

14 February 2018
advanced therapy medicinal product, aseptic manufacturing, ATMP, biosafety, clinical trials authorisation, CTA, data integrity, decentralized manufacturing, GMO, GMP, HE, hospital exemption, IMP, investigational medicinal product, MAH, manufacturer, manufacturing, manufacturing platform, marketing authorisation, marketing authorisation holder, operating theatre, process validation, risk assessment, sponsor, unmet medical needs,

On 22 November 2017, the European Commission (EC) has adopted and published Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products, one of the initiatives of the Action Plan for ATMPs launched in October 2017 to foster the development of ATMPs. Advanced Therapy Medicinal Products (ATMPs) manufacturers should comply with these Guidelines

Revised guideline on manufacture of the finished dosage form (Part II)

7 December 2017
bulk, control strategy, CPP, critical process parameter, CTD, design space, finished product, hold time, intermediate, manufacture, process description, RTRT, storage, transport, validation,

On 14 August 2017, the European Medicines Agency (EMA) published revised version of Guideline on manufacture of the finished dosage form. This revised document will become effective on 14 February 2018. We have already informed on our website about a draft of the revised guideline published by the European Medicines Agency (EMA) for public consultation

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.

Clinical investigation of medicinal products in the pediatric population – Addendum to ICH E11

17 October 2017
clinical trial, drug development, extrapolation, formulation, ICH E11, modeling, pediatric formulation, pediatric population, simulation,

On 6 October 2017, the European Medicines Agency (EMA) published revised version of ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population in the form of an addendum. This document will become effective on 28 February 2018. Pediatric drug development has evolved since the original ICH E11 Guideline (2000), requiring consideration

(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

Revised guideline on first-in-human clinical trials (FIH CTs) (Part II)

30 July 2017
early clinical trials, FIH, first-in-human, IMP, integrated protocols, investigational medicinal product, phase I, risk mitigation,

On 25 July 2017, the European Medicines Agency (EMA) published revised version of Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products. This revised document will become effective on 1 February 2018. We have already informed on our website about a draft of the revised guideline