ISPE Raises the Bar for Baseline Guides

April 2, 2010
Susan J. Schniepp
Susan J. Schniepp

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Pharmaceutical Technology, Pharmaceutical Technology-04-02-2010, Volume 34, Issue 4

New information improves an organization's guide to building manufacturing facilities.

The International Society for Pharmaceutical Engineering (ISPE) recently published the second edition of its Baseline Pharmaceutical Engineering Guide for Oral Solid Dosage Forms. This comprehensive volume takes a soup-to-nuts approach to guiding pharmaceutical manufacturers in building new facilities, and renovating existing facilities, to meet current global regulatory expectations. The book's layout is user friendly and includes visible tabs for easy reference.

ISPE Baseline Pharmaceutical Engineering Guide for New and Renovated Facilities: Volume 2, Oral Solid Dosage Forms, International Society for Pharmaceutical Engineering, ISPE, Tampa, FL, 2010, 184 pp., ISBN 1-931879-67-2

The various sections, including the introduction, are outlined in the same basic format, which helps readers to refer to other chapters and maintains the book's continuity. Each division opens with an introductory statement that highlights the chapter's content. A few of the guidance chapters have diagrams, tables, or charts that succinctly summarize much of the information presented in the chapter. In addition to these graphics, the authors have included cross-references to other chapters in the text so the reader can quickly refer to the appropriate chapters and obtain a clear and comprehensive understanding of a topic and its related requirements.

It is worth the reader's time to peruse the introduction because it highlights the major changes that differentiate this new volume from the one published in 1998. The scope of the baseline guide is confined explicitly to solid oral dosage forms and key concepts that may be applied to clinical and commercial manufacturing facilities. In addition, the "Scope of this Guide" section tells the reader where to find similar information for facilities that manufacture excipients or injectables; readers don't need to guess about how to adapt this information to those specific operations. The introductory chapter has a subsection titled "Key Features of this Guide," which codifies the regulatory and compliance premises that form the basis for the information that follows in the subsequent chapters.

After absorbing the introduction, the reader should review the appendices. All of the appendices are useful, but three in particular stand apart. Appendix 6 is a comprehensive glossary of the common terms used throughout the manual. The appendix also includes definitions that help readers interpret some of the information that the book provides. Appendix 5 provides a thorough list of references for readers who would like to know about the sources of some of the book's information. These references are cited throughout the body of the manual as well.

Appendix 4, titled "HSE International Regulations and Standards Cross References," is the most useful. It displays in columns the regulatory references for many of the attributes that must be considered when building or renovating a solid oral dosage-form manufacturing facility. For example, if the reader needs to know the regulations that govern air emissions, he or she can locate this information in section 15.5 of Appendix 4, where the appropriate regulatory citations for this requirement for the United States, Canada, and the European Union are provided. Section 15.8 lists Japanese laws and regulations. This appendix emphasizes the global applicability and appeal of this manual.

Section 11, titled "Risk-Based Approaches to Commissioning and Qualification," is new to the manual and offers basic concepts regarding risk assessment as it applies to this specific topic. This chapter guides readers through the commissioning and qualification processes and gives a synopsis of the various sections contained in the American Society for Testing and Materials (ASTM) standard that is the chapter's reference document. Although this chapter is not particularly useful on its own, it gives enough information about the ASTM E2500 standard for the user to determine whether it is worth purchasing.

A few chapters in the manual could have benefited from more explanation and text. One example is Chapter 2, "Concepts and Regulatory Philosophy," which gives overly general examples of how certain philosophies apply to solid oral-dosage facilities. It might have been more beneficial to readers if a case study had been used to exemplify the issues and philosophies discussed.

An even more interesting concept would have been to add a section to the introduction that described a fictitious company's need to retool an existing facility and build a new facility. The book could have followed these two scenarios through each chapter and given readers an idea of how the concepts and philosophies explained in the book work in practice rather than in theory.

Overall, the ISPE manual is a valuable document that is well organized and informative. When the information is not as complete as the reader might need, the book offers numerous references to other information sources where more detailed data can be found. The international relevance of the book makes this a practical document for companies that seek to build or renovate their solid oral dosage-form manufacturing facilities, wherever they happen to be located.

Susan J. Schniepp is president of Schniepp and Associates and a member of Pharmaceutical Technology's Editorial Advisory Board,