January / February 2017

Upcoming Guidance Document: ISPE Sampling for Pharma Water, Steam & Process Gases

Guidance Document Callout

The intent of sampling is to take a small but representative portion of a much larger stream where the sample collected accurately represents the content of the larger stream. The sample collected should not be altered or changed in any way because of the sampling process, but this is an almost impossible proposition as all sampled utilities come into contact with air, containers, etc., during the sampling process.

Effective sampling is of paramount importance to the success of any pharmaceutical critical utility system. Extracting a representative sample from a utility system can be an involved and complicated process and either an error or errors may be introduced. Improper sampling may have a negative impact on company image, cost, productivity, ethics, and regulatory liability.

This ISPE Good Practice Guide on Sampling for Pharmaceutical Water, Steam, and Process Gases affects users of water, steam, compressed air, or process gases and impacts facilities, production, and quality control personnel within a facility. This Good Practice Guide applies to manufacturers of pharmaceuticals, medical devices, biologics, cosmetics, and related products as well as equipment manufacturers, vendors, and other industries outside of the pharmaceutical arena.