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ICH guidelines - Articles and news items

Dave Elder, GlaxoSmithKline and JPAG

Foreword: The evolving pharmacopoeia

Issue 1 2016 / 29 February 2016 / Dave Elder, GlaxoSmithKline and JPAG

Globalisation has facilitated greater international harmonisation and standardisation of quality standards, which in turn has impacted on pharmacopoeias. Historically, general chapters were developed based on input from local regions with little concern for global consequences. This often led to the development of similar, but unidentical tests, for example, Residue on Ignition (USP <281>) versus Sulphated Ash (Ph.Eur., 20414; JP, 2.4.44) . Similarly, pharmacopoeial monographs of active pharmaceutical ingredients (APIs) were developed primarily based on the input of the innovator and single sources of the API. In contrast, today’s monographs must reflect multi-source APIs from many generic suppliers, typically from India and China, rather than from Western Europe and the United States. Consequently, the test methods must be cheap, globally available and state-of the-art, but selective and robust – often a significant challenge…

The application of skip testing to drug substance manufacture

The application of skip testing to drug substance manufacture

Issue 1 2016, PAT & QbD / 29 February 2016 / Phil Borman, Simon Bate and Keith Freebairn, GlaxoSmithKline

Skip testing is a process employed to reduce the analytical drugs testing burden and lends itself to processes with high frequency batch production. Rather than test all batches within a given interval, pre-selected batches are assessed and the other batches ‘skipped’. This reduction is justified as it is shown that there is a low risk of any batches failing specification. In this article, a process is described (supported by an example) that could be followed to justify the use of skip testing. The process involves identifying attributes that are candidates for skip testing, performing a statistical evaluation to confirm there is a low risk of batch failure if skip testing is instigated and making ongoing assessments to confirm the process remains highly capable and the attribute(s) is predicted to be well within specification…

David Elder

Foreword: Importation testing: an unnecessary burden on industry?

Issue 5 2015 / 22 October 2015 / Dave Elder, GSK & JPAG / Karl Ennis, GSK

One of the principle objectives of the Internal Conference on Harmonisation (ICH) initiatives was to introduce harmonised approaches, prevent duplication and eliminate wasteful and unnecessary testing. Although good progress was made initially, there was evidence that certain countries, regions and trans-national organisations were unhappy with some of the proposed harmonised guidances, as exemplified by the withdrawal of ICH Q1F…

Review of regulatory changes impacting on pharamceutical microbiology

Review of regulatory changes impacting on pharamceutical microbiology

Issue 6 2014 / 23 December 2014 / Dr Tim Sandle, Bio Products Laboratory

This article surveys some of the recent developments in regulatory requirements and standards that have taken place during the past 12 months, highlighting those aspects that are of relevance to pharmaceutical microbiology…

David Elder

Foreword: What does quality mean to you?

Issue 3 2014, PAT & QbD / 3 July 2014 / Dave Elder, GlaxoSmithKline and JPAG

An effective quality risk management (QRM) process ensures proactive identification and control of potential issues that may arise during development and commercialisation. Where quality is defined as the degree to which a set of intrinsic properties of a drug product, its underpinning manufacturing process, and any supporting processes fulfils the pre-determined criteria…

Francisca Gouveia, 4Tune Engineering Ltd

Pharma development and manufacturing with QbD 2.0

Issue 3 2014, PAT & QbD / 3 July 2014 / José Menezes, Institute of Biotechnology and Bioenginerring, IST, Universidade de Lisboa / Francisca Gouveia and Pedro Felizardo, 4Tune Engineering Ltd

Pharma and BioPharma industries are aware of the impact of production processes on sustainability of business operations. To improve performance, companies have recognised that it is necessary to better understand the drivers of both costs and revenues and the actions that can be put in place to address them. In the past, commercial manufacturing emphasis was on full compliance with initially established product specifications leading to a perception of quality assurance based on testing, and avoiding later changes after regulatory submission. Although final product testing is an important element of quality control, final product quality can be measured but not modified, leading to product rejection or reprocessing activities and underperforming business outcomes, two kinds of waste according to lean manufacturing…

Foreword: ICH Q6A - Specifications: Test procedures and acceptance criteria for new drug substances and new drug products: chemical substances

Foreword: ICH Q6A – Specifications: Test procedures and acceptance criteria for new drug substances and new drug products: chemical substances

Issue 6 2013, PAT & QbD / 15 December 2013 / Dave Elder, GlaxoSmithKline and JPAG

Specifications (test and acceptance criteria) for active pharmaceutical ingredients (APIs) and drug products are defined in ICH Q6A. It ‘establishes a set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use.’ The guidance is sub-divided into universal tests applicable to all APIs and drug products, i.e. description, identity, assay and impurities; as well as those specific tests which are applicable on a case-by-case basis. Thus, specifications are critical quality criteria that are proposed and justified by the manufacturer and subsequently approved by the licensing authority…

David Elder

ICH Q3D: Metal Impurities: A Critical Evaluation

Issue 5 2013, PAT & QbD / 22 October 2013 / David Elder, JPAG and GlaxoSmithKline / Andrew Teasdale, JPAG chairman and AstraZeneca

Historically, control over metal impurities has been achieved via pharmacopoeial heavy metals limit tests, e.g. United States Pharmacopeia (USP) <231>. These tests involve the formation of a metal sulphide precipitate, but such methods are non-specific and inaccurate for many elements. As a consequence, there has been a concerted drive by industry, pharmacopoeias and regulators to develop more effective approaches to the analysis and control of elemental impurities, leading to a number of international guidelines…

Dave Elder, Joint Pharmaceutical Analysis Group and GSK

Foreword: ICHQ2(R1) Validation of Analytical Procedures – Challenges and Opportunities

Issue 4 2013 / 20 August 2013 / Dave Elder, Joint Pharmaceutical Analysis Group and GSK

The International Conference on Harmonisation (ICH) guideline for the Validation of Analytical Procedures (ICHQ2(R1)) currently covers validation procedures for the four most common analytical tests: identification tests, quantitative tests for impurities, limit tests for the control of impurities and quantitative tests for the active moiety(ies) in APIs (active pharmaceutical ingredients) or drug products. The key underlying concepts and strategies are equally applicable to other analytical methodologies; e.g. particle size analysis, dissolution, etc. Typical validation parameters covered in the guideline include accuracy, precision, specificity, detection limits (DL / LOD) and quantitation limits (QL / LOQ), linearity, range and robustness.

A pragmatic approach for the adoption of QbD principles for analytical method development and validation

A pragmatic approach for the adoption of QbD principles for analytical method development and validation

Issue 2 2013, PAT & QbD / 18 April 2013 / Heike Gottschalg, Rüdiger Gössl, Holger Memmesheimer and Holger-Thorsten Steinführer, Boehringer Ingelheim Pharma GmbH & Co KG

The principles of the application of Quality by Design (QbD) in the pharmaceutical industry in terms of development, manufacturing and control are well defined and described in the ICH guidelines Q8, Q9 and Q10. These guidelines mainly focus on the quality of the drug products, their manufacturing processes and the definition of a respective design space. The overall objective of QbD is to increase product understanding and to ensure a science and risk based approach in pharma – ceutical development.


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