Education Sessions

E-GU1
API (Bulk) Baseline® Guide – An Applications Workshop

4 November 15.00-17.00 Track: Guides & Guidance Documents

ISPE CEUs: 0.2

The API (Bulk) Pharmaceutical Chemicals Baseline Guide, originally published in June 1996, has just undergone a complete revision. Review key changes and interact with the authors in a workshop setting.

The revision of this Guide provided the opportunity to incorporate specific current Good Manufacturing Practices (cGMP) considerations for pharmaceutical manufacturing regions and to address key issues, such as containment, which were not included in the original Guide. Terminology has been made consistent with the more recent Commissioning and Qualification Baseline Guide and the ICH Q7A Guideline. The Guide addresses Bulk Pharmaceutical Chemicals (BPC) including both Active Pharmaceutical Ingredients (API) and excipients.

Take Back to Your Job

  • Know the latest revisions to the API (Bulk) Pharmaceutical Chemicals Baseline Guide
  • Understand the impact these revisions have for active pharmaceutical ingredients (API) facilities
  • Apply risk-based approach in the design, operation
    and validation of API facilities

Who Should Attend

This workshop is specifically designed to meet the current and evolving needs of professionals engaged in planning, design, operation, validation and maintenance of API facilities.

Community of Practice: Active Pharmaceutical Ingredients (API)

Session Leaders

 

Sponsors