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What Are the Latest Guidelines for Excipients?


Guy Tiene


Strategic Content Director That’s Nice / Nice Insight


The global outlook for excipients looks bright, as the market is expected to grow at an annual compound rate of of 7.6% from 2015 to 2020, reaching $6.4 billion by 2020.1


The major factors driving market growth


are the growing demand for pharmaceutical products and functional excipients, the increasing generic drug market, and the emergence of new excipients. Drug manufacturers also rely on excipients to develop value-added and distinct products at a lower cost without compromising quality, such as extended-release formulations.


The industry seeks novel multifunctional excipients that can improve solubility and absorption, enhance disintegration and increase stability for biologics/parenteral formulations. Novel excipients are also in high demand for developing novel drug delivery systems, such as nanotechnology-enabled and liposomal delivery systems. Co-processed excipients, combining two or more existing excipients into one product, are expected to gain market approval faster than those with a completely new chemical entity.


According to the 2015 Nice Insight Excipient Survey2 of 412 drug


manufacturers who acquire excipients and 189 excipients suppliers, 28% of buyers spend $1 million to $10 million annually for excipients and more than one third spend $10 million to $100 million. The majority of excipients buyers were from emerging, niche and startup companies (24%), as well as biotech/biologics (23%) and big pharma companies (23%).


However, despite the positive outlook, a number of looming issues can weaken the growth of this market, including increasingly stringent regulatory requirements, supply chain issues, declining investments in R&D by pharmaceutical excipient producers and high market fragmentation. In this article, we look at the impact of current regulatory expectations, supply chain issues and other industry challenges.


Regulatory Guidelines and Requirements


Excipients are present in the final drug product, but contaminated products must not reach patients.


Detailed below are some of the latest global guidelines for excipient risk assessment and ensuring product safety:


EMA Guidelines on Excipient Risk Assessment (2015) Last year, the European Union issued, "Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good


IPEC and Supply Chain Security


The International Pharmaceutical Excipient Council (IPEC) is an industry group that focuses on harmonizing compendia, and produces GMP and GDP standards for pharmaceutical excipents internationally. Its publications - IPEC-PQG (Pharmaceutical Quality Group) GMP Guide 2006 and IPEC GDP Guide 2006 - are broadly recognized as industry standards and are voluntarily applied to excipient manufacturing and distribution.


In May 2015, IPEC responded to the EMA guidelines by issuing a position paper supporting risk assessment, but with concerns over timing. The paper also emphasized that collaboration, communication and cooperation along the entire supply chain is necessary to avoid gaps in a holistic risk-assessment process. Further, IPEC views third-party auditing and certification programs and national standards, such as NSF/IPEC/ANSI 363-2014 and EXCiPACT GMP and GDP standards, as essential to comply with the new requirements to qualify excipients and their suppliers.


The IPEC guidance helps ensure minimal contamination and consistent product. The authorities in Europe, and to a growing extent in the US, are looking for drug product manufacturers to be in control of their entire supply chain. This is to better understand what their excipient manufacturers are doing, how they control their processes and the potential contaminants and impurities.


Pharmaceutical Outsourcing | 26 | July/August 2016


manufacturing practice for excipients of medicinal products for human use." Pharmaceutical manufacturers were challenged to implement the guidelines for products in development or authorized by March 21, 2016, including performing a risk assessment of each of its excipient suppliers to determine the GMP expectations. This risk assessment can be obtained through audit or from information received from the excipient manufacturer.


The guidelines' requirements for determining and ensuring appropriate GMP are challenging and result in a significant initial expense. Companies must extend their risk profiles for excipients to comply with the new requirements. The appropriate GMP and risk profiles for both the excipient and the excipient manufacturer have been prepared for all authorized products in less than a year. While most industry companies and organizations agreed on the need for such guidelines, the major concern was meeting the short deadline, as well as the costs, for compliance.


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