Biomedical Engineering Reference
In-Depth Information
TABL E 13.1. Standards from the ASTM E55 Committee on Manufacture
of Pharmaceutical Products
Approved Standards
Scope
E2474-06 standard practice for
pharmaceutical process design by using
process analytical technology
Development and implementation of
process understanding
E2500-07 standard guide for specification,
design, and verification of pharmaceutical
and biopharmaceutical manufacturing
systems and equipment
All systems with the potential to affect
product quality and safety
E2503-07 standard practice for
qualification of basket and paddle
dissolution apparatus
Setup and calibration of dissolution
apparatus.
E2537-08 standard guide for application of
continuous quality verification to
pharmaceutical and biopharmaceutical
manufacturing
Validation of processes where performance
is monitored continuously.
E2363-06a standard terminology relating to
process analytical technology in the
pharmaceutical industry
Defines terminology specific for PAT as
used in the pharmaceutical industry
Standard practice for risk management as it
impacts the design and development
of processes for pharmaceutical
manufacture
Risk management and assessment for
processes using PAT principles.
Standard practice for process understanding
related to pharmaceutical manufacture
and control
Builds on understanding as described on the
PAT Guidance
Standard guide for the application of
continuous processing technology to
the manufacture of pharmaceutical
products
Identifies principles of continuous
processing for pharmaceuticals
Standard practice for process sampling
Sampling considerations for PAT
Standard practice for qualification of PAT
systems
Qualification of systems using PAT
principles
Standard guidance for multivariate analysis
related to process analytical technology
Development and use of MVDAmodels and
controls
Standard guidance for identification of
critical attributes of raw materials in
pharmaceutical industry
Applies knowledge and understanding to
selection of materials
Guide for validation of PAT methods
Applies to in-line, online, and near-line
spectroscopic methods.
Online total organic carbon (TOC) method
validation in pharmaceutical waters
Validation of online analyzers
Guide for science-based and risk-based
cleaning process development and
validation
PAT for cleaning processes and cleaning
validation
