ASTM Pharmaceutical Standards (existentes)

E2363 Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry.

E2474 Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology.

E2475 Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

E2476 Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of
PAT Processes for Pharmaceutical Manufacture.

E2537 Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical
Manufacturing.

E2629 Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems.

ASTM E2500 - 13 Standard Guide for Specification, Design, and Verification of Pharmaceutical and
Biopharmaceutical Manufacturing Systems and Equipment.

Subcommittee E55.03 on General Pharmaceutical Standards

Showing results 1-8 of 8 matching ACTIVE standards under the jurisdiction of E55.03 E55 Home

E2500-13 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical
Manufacturing Systems and Equipment

E2503-13e1 Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus

E2537-08 Standard Guide for Application of Continuous Quality Verification to Pharmaceutical and
Biopharmaceutical Manufacturing

See also WK46216 proposed revision

E2656-16 Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic
Carbon Attribute

See also WK55465 proposed revision

E2810-11e2 Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage
Units

E3051-16 Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in
Pharmaceutical and Biopharmaceutical Manufacturing

E3060-16 Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using
Dynamic (Flow) Imaging Microscopy
F838-15a Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid
Filtration

Showing results 1-3 of 3 matching Proposed New Standards under the jurisdiction of E55.03 E55 Home

WK15778 New Guide for Science-based and Risk-based Cleaning Process Development and Validation.

WK51651 Standard Guide for Raw Material eData Transfer between Pharmaceutical & Biopharmaceutical and
their Suppliers.

WK52609 Standard Practice / Guide for Validating End-user Sterilizing Filtration of Pharmaceutical,
Biopharmaceutical, and Biological Products.

0 matching WITHDRAWN standards under the jurisdiction of E55.03 E55 Home