ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring

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The ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring provides industry good manufacturing practices for the temperature mapping of controlled temperature chambers, along with development of test acceptance criteria and a risk-based approach to practices for periodic review of system performance. The approach described is consistent with that described in the ISPE Good Practice Guide: Cold Chain Management.

Guidance is provided on Controlled Temperature Chambers used to store raw material, work in progress, or finished product, and which operate under current Good Manufacturing Practices (cGMPs). A Controlled Temperature Chamber is defined as a system, unit, equipment, or room in which the environmental conditions (usually temperature) of a chamber are controlled, maintained, and regulated to meet specific user requirements.

Types of Controlled Temperature Chambers considered by this guide include:

• Purchased Commercial Off the Shelf (COTS) items (such as freezers, refrigerators, and incubators)
• Warm rooms designed to maintain consistent temperatures
• Ovens, and custom built units, such as controlled room temperature environments, e.g., warehouses, walk-in cold rooms and freezers. Freezers can be used for short to long term preservation of pharmaceutical and biopharmaceutical materials, e.g.:
  • Active Pharmaceutical Ingredients (APIs)
  • Process intermediates
  • Stability samples
  • Laboratory materials
  • Cell banks

Guidance is provided on the definition of the requirements (producing a user requirements document), design, purchasing, commissioning (including temperature mapping), qualification, and maintenance of controlled temperature chambers operating under cGMPs.

Product Details

Published:

2016

ISBN(s):

9781936379866

Number of Pages:

116

File Size:

1 file , 2.8 MB