ASTM E2629-20

Действует

Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems — 7 стр.

Ссылочные документы

ASTM E2537-16(2024)

Действует

Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing — 5 стр.

ASTM E2500-20

Действует

Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment — 6 стр.

ASTM E2476-22

Действует

Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture — 11 стр.

ASTM E2363-23

Действует

Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry — 16 стр.

ASTM E122-17(2022)

Действует

Standard Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process — 5 стр.

ASTM E2629-19

Заменен

Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems — 7 стр.

На этот документ ссылаются

ASTM E2986-18

Заменен

Standard Guide for Evaluation of Environmental Aspects of Sustainability of Manufacturing Processes — 8 стр.

ASTM E2986-22

Действует

Standard Guide for Evaluation of Environmental Aspects of Sustainability of Manufacturing Processes — 7 стр.

ASTM E2629-19

Заменен

Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems — 7 стр.

ASTM E2629-11

Заменен

Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems — 6 стр.

ASTM E2500-13

Заменен

Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment — 5 стр.

ASTM E2898-20a

Действует

Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications — 7 стр.

ASTM E2474-14

Отменен

Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020) — 3 стр.

ASTM E2500-20

Действует

Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment — 6 стр.