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How Should Pharmaceutical Excipient Manufacture be Controlled?

Excipients - The Inseparable Ingredients

Medicines and excipients are inseparable, with few exceptions - one can not exist without the other. This article will explore the definition and significance of excipients and highlight the importance of implementing the correct excipient manufacturing controls. The Pharmaceutical Quality Group (PQG) and other international bodies have developed GMP standards and guidelines to facilitate effective supply of excipients (1).

An excipient is any starting material ingredient used in the formulation of a medicine, which is not an active pharmaceutical ingredient (API). It can include ingredients that are later 'lost' from the medicine, such as solvents. Excipients can have a range of effects on consumer acceptance, safety and the efficacy of medicines. These effects can be as basic as improving the organoleptic qualities of the medicine through to influencing its effectiveness during use (2). Examples are provided later in the article to illustrate this point.

GMP Controls for Excipients are Still Undefined


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By Ashley McCraight and Dr Steve Moss from the Pharmaceutical Quality Group (PQG) of the Institute of Quality Assurance

Ashley McCraight obtained a degree in Chemistry from Birmingham University, following which he joined Glaxo where he occupied numerous roles in QC, analytical development, QA, manufacturing and purchasing. During this time he gained practical experience at Public Analyst's laboratories, eventually becoming Company QA Manager for Glaxo Pharmaceuticals.

Ashley is leader of the PQG's supplier development project team. This team has produced internationally-recognised GMP application standards and training guides for suppliers of packaging materials and excipients. He currently manages a business offering consultancy in quality management and the Acumen supplier evaluation service to the pharmaceutical industry. He is a Member of the Institute of Quality Assurance (IQA), as well as a qualified person (QP) within the European Union.


Dr Steve Moss is Manager of New Product Supply & Business Development, within a global QA group of GlaxoSmithKline in the UK. The position involves carrying out due diligence assessments for in-licensing agreements, auditing suppliers and contractors for new products, and managing regulatory inspections. Steve has a BSc and PhD in Chemistry as well as an MBA. He worked in the chemical industry for eight years in development, production, project and engineering management roles.

Steve joined Glaxo around 10 years ago and has managed Supply Quality sections covering raw materials and packaging materials suppliers. His activities have mainly focused on developing systems, auditing and supplier development. Steve is an active member of the UK's Pharmaceutical Quality Group, leading the team preparing excipients GMPs, and working with IPEC Europe and Americas on a joint GMP guide.


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Ashley McCraight
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Dr Steve Moss
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