ISPE releases revamped API guide

This latest volume forms part of the organization's Baseline​ series of publications, one of a range of publications providing technical advice to the pharmaceutical industry. The Baseline Guides, including this latest addition, are created in partnership with the US Food and Drug Administration (FDA) and aim to offer practical answers to challenges posed to facility designers, as well as providing an understanding of products and processes. The renewed API guide released this week is an updated version of the Bulk Pharmaceutical Chemicals guide published back in 1996, and offers significant additions and revisions over its predecessor. The name change (referring to APIs rather than 'bulk' chemicals) was intended in part to reflect the European direction of the document, and demonstrate the fact that it is not directed solely at US manufacturers. The new guide incorporates new guidelines and regulations on a number topics, including: 21 CFR Part 11 (regarding electronic records and signatures), ICH Q7 on good manufacturing practices for APIs, ICH Q9 on quality risk management, GAMP 4 on the validation of automated systems and FDA draft guidance for industry PAT (process and analytical technology). One other key addition to the publication is that the new edition covers specific good manufacturing practice considerations for pharmaceutical manufacturing regions outside of the US, particularly useful for firms establishing production bases around the world to take advantage of low-cost destinations or widen their geographical reach. "The revision was prompted by a number of developments and initiatives within the industry, along with comments from users of the original guide,"​ said Patrick Wong of Bristol-Myers Squibb and lead of the Guide's development task force. The revised guide will still cover topics covered in the original publication, but the general scope has been widened with key features now including API characterization, critical process steps, contamination review, design qualification, intended patient use, process analytical technologies, process review, risk to patient and process understanding, among a number of other matters. The 188 page guide is available to the pharmaceutical industry now, at $200 for ISPE members and $400 for non-members. A bound/electronic version will be available next month, and a secure PDF version will be available for download from the IPSE website late this year. The organization has a number of titles currently undergoing revisions to provide the pharmaceutical industry with guidance on numerous aspects of the sector. According to ISPE, its publications aim to provide the "real world" information to help companies build on current best practices to meet (and exceed) regulatory requirements. Other topics in the Baseline​ series include water and steam systems, commissioning and qualification, and biopharmaceuticals amongst others. In addition to the Baseline range, ISPE also publishes a good practice series (most recently updated with the Commissioning and Qualification of Pharmaceutical Water and Steam Systems​ volume back in February this year) and a good automated manufacturing practice (GAMP) line, as well as providing a whole range of other resources and expertise to the pharmaceutical industry.