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David Elder - Articles and news items

Ingredients In-Depth Focus 2016

Ingredients In-Depth Focus 2016

Issue 5 2016, Supplements, Z Homepage promo / 20 October 2016 / European Pharmaceutical Review

In this Ingredients In-Depth Focus: Excipient quality and supplier interchangeability; Interpreting ICH’s evolving residual solvents guideline; Q&A with Meggle…

David Elder

Foreword: Biosimilars – future prospects

Issue 3 2016 / 30 June 2016 / Dave P. Elder, JPAG chair and Consultant

Biologically-derived drugs, such as proteins, peptides and monoclonal antibodies (mABs), are playing an increasingly important role in global healthcare. It was recently reported that mAB therapeutics sell for over $50 billion globally. However, one of the major downsides of biological therapeutics is their significantly greater costs compared with small molecule drugs, which puts an increased burden on global health services…

David Elder

Use of the ‘purge tool’ in assessing mutagenic impurities

Issue 6 2015, PAT & QbD / 6 January 2016 / Dave Elder, GlaxoSmithKline and JPAG

The International Conference on Harmonization M7 text provides guidance on establishing acceptable levels of mutagenic impurities (MIs) . It also outlines the safety and quality risk management processes that manufacturers need to undertake to control MIs that may potentially affect the drug substance or drug product. Over the past decade, some of the most significant challenges facing the pharmaceutical industry have been linked to performing genotoxic risk assessments (GRAs) and implementing a control strategy, including the analysis of these MIs and potentially mutagenic impurities (PMIs) at very low levels (ppm) in drug substances and products…

David Elder

Foreword: The importance of good distribution practice

Issue 4 2015 / 3 September 2015 / Dave Elder, GlaxoSmithKline and JPAG

Historically, the regulation and control of medicinal products has relied on national and supranational guidelines covering good manufacturing practice (GMP). However, the quality of these medicinal products can be adversely affected by a lack of adequate control over the myriad activities that occur during the distribution process. In addition, the necessity for developing, establishing and maintaining an adequate control system has not generally been well understood. This may result in differences in documentation practices and handling requirements, as well as complex communication between the various organisations, companies, groups or entities that comprise the supply chain…

Dave Elder, GlaxoSmithKline and JPAG

Drugs shortages are finally being addressed

Issue 3 2015, Manufacturing & Packaging / 3 July 2015 / Dave Elder, GlaxoSmithKline and JPAG

Maintaining the security of the supply chain for drug products is a significant responsibility to ensure the sustained availability of safe medicines…

Dave Elder, GlaxoSmithKline and JPAG

Precompetitive collaborations in the pharmaceutical industry

Issue 2 2015 / 20 April 2015 / Dave Elder, GlaxoSmithKline and JPAG

Increasing research and development costs, low productivity, reduced product life cycles, governmental pricing containment, convergence of technologies and increasing regulatory oversight are challenges that increasingly provoke pharmaceutical companies into making precompetitive collaborations with other organisations. Organisations that would typically compete with one another are now realising the benefits of working together to share information. Janet Woodcock, Acting Director of the US Food and Drug Administration’s Office of Pharmaceutical Quality has defined precompetitive research as ‘a subset of translational research that is focussed on improving the tools and techniques needed for successful translation, and not on development of a specific product’. Enhanced cross-industry collaborations increase efficiency, innovation, sustainability and ultimately patient benefit…

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…

Dave Elder, Joint Pharmaceutical Analysis Group and GSK

Foreword: Is risk in the eye of the beholder?

Issue 2 2014 / 15 April 2014 / Dave Elder, GlaxoSmithKline and JPAG

An effective quality risk management (QRM) process provides a key mechanism for the proactive identification and control of potential issues that may arise during product development and subsequent commercialisation1. In this context, risk is defined as the combination of the probability of occurrence of harm (or unwanted outcome) and the severity of that harm (or unwanted outcome). Scientific approaches are used to estimate the likelihood of any given risk1. An extreme approach is the concept of ‘zero risk’.

Dave Elder, Joint Pharmaceutical Analysis Group and GSK

ICH M7 Mutagenic impurities: A critical evaluation

Issue 1 2014 / 19 February 2014 / Dave Elder, GlaxoSmithKline and JPAG

Whereas the existing ICH quality documents covering impurities in new drug substances (ICH Q3A(R2)) and drug products (ICH Q3B (R2)) provide a framework for the qualification and control of most commonly encountered impurities and degradants, it is recognised that lower thresholds may be appropriate if the impurity is unusually toxic (e.g. DNA reactive). The emerging ICH M7 guidance seeks to provide a practical basis for the identification, characterisation, qualification and control of mutagenic impurities. Its role in the pantheon of guidance is therefore to supplement and complement the existing guidance enshrined in ICH M3(R2), ICH Q3A(R2), ICH Q3B(R2) and probably the emerging ICH Q3D document…

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.

 

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