Standard Guide on Sampling for Process Analytical Technology

Importancia y uso:

4.1 Application of this guidance should enable PAT method developers to design and implement reliable PAT applications that avoid many common sources of error around sampling. Sampling is a key element of method and process validation plans. Scientific and statistical principles should be used in combination with appropriate risk assessment tools to ensure that the sampling approach is suitable for the application.

4.1.1 Many ASTM standards discuss sampling; however, almost all are very specific to a certain field or application. For example, the “Practice for Automatic Sampling of Petroleum and Petroleum Products” (D4177) specifically covers information for the design, installation, testing, and operation of automated equipment for the extraction of representative samples of petroleum and petroleum products from a flowing stream and storing them in a sample receiver.

4.1.2 Other useful ASTM standards include: E105 (Practice for Probability Sampling of Materials), E122 (Practice for Calculating Sample Size to Estimate, With a Specified Precision, the Average for a Characteristic of a Lot or Process), E1402 (Guide for Sampling Design), and E456 (Terminology Relating to Quality and Statistics). These standards review similar considerations as those addressed in this guidance and can be consulted for additional insight on how to deal with specific sample types or situations. However, such standards should be carefully reviewed for relevance to pharmaceutical applications.

Subcomité:

E55.14

Volúmen:

14.01

Número ICS:

71.120.01 (Equipment for the chemical industry in general)

Palabras clave:

PAT; process analytical technology; sampling;