ISPE Baseline Guide: Volume 2 - Oral Solid Dosage Forms [ Withdrawn ]

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 02/01/1998

Full Description

Many Oral Solid Dosage (OSD) facilities run multiple products in processing areas designed for quick turnaround without unacceptable risk of product exposure, (i.e., dust and cross-contamination). Additionally, potent or toxic active ingredients are becoming increasingly common and present their own design challenges. The Oral Solid Dosage Baseline Guide assists professionals by establishing consistent and minimum parameters for facility design, which address these concerns and meet GMP requirements.

In addition, the Guide provides engineers and professionals in the pharmaceutical industry with consistent guidance on the design, construction, and commissioning of OSD facilities, equipment, and systems. The Guide covers facilities manufacturing oral solid dosage forms (i.e., tablets, capsules, and powder) and also may be applied to clinical supply facilities. It is not intended to address the manufacture of vitamins, excipients, sterile products, topicals, oral liquids, or aerosols.

The key concepts defined and used as a basis for this Guide include:

- proper application of facility design and procedures to provide GMP compliance
- non-GMP technology and its impact upon facility design and costs
- contamination risk as assessed by the manufacturer
- design conditions versus operating range
- good engineering practice (GEP)
- enhanced documentation

Product Details

Published: 02/01/1998 ISBN(s): 193187901X Number of Pages: 92