Guidance for Preparing Documentation That Meets Regulatory Requirements

Successful operations require a working union of the day-to-day communications to keep the wheels turning. Proper documentation affirms control of the business activities. With the sheer volume of documentation that takes place in the pharmaceutical industry, writing is a critical skill, one that is essential for success. This text is about writing for the pharmaceutical industry. It represents a brief overview of the regulatory environment and documentation requirements to identify the roles of writers and readers, and the purpose of good documentation. The book offers a broad range of documents representative of the types of writing that takes place in the industry, from the laboratory to Quality Assurance, to manufacturing and regulatory affairs. It also provides native and non-native writers of English with detailed guidelines for controlling the language.

Contents include:

• Writing within the Regulatory environment
  
• Connecting writer and reader
  
• Organizing and delivering information
  
• Writing letters and memos
  
• Preparing routine reports
  
• Process reports
  
• Periodic and progress reports
  
• Developing a clear style
  
• Building strong sentences
  
• Verb tenses in English
  
• Punctuating effectively
  
• Working on words

2000, Hardcover, 368 pages

Interpharm Press, Inc., 15 Inverness Way E., Englewood, CO 80112-5776. Tel: 303-662-9101; Fax: 303-754-3953.