ASTM Pharmaceutical Standards
ASTM pharmaceutical standards provide the foundation for quality, safety, and performance in drug development and manufacturing.
They support every stage of the pharmaceutical lifecycle, from raw material testing and laboratory practices to finished product evaluation and packaging integrity.
By creating consensus-driven methods that are globally recognized, these standards ensure that medicines meet rigorous benchmarks for purity, efficacy, and consistency.
Developed through the work of ASTM Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products, these standards cover critical areas such as process control, analytical methods, biopharmaceutical manufacturing, and quality management systems.
Together, they offer a reliable framework that regulators, manufacturers, and testing laboratories depend on to ensure patient safety and industry compliance.
Digital Access to Pharmaceutical Standards
ASTM’s pharmaceutical standards program is continuously updated to reflect the latest advances in technology, science, and regulatory expectations.
New standards are regularly developed to address emerging challenges such as continuous manufacturing, advanced analytical techniques, and personalized medicine.
Through ASTM Compass®, professionals gain access to the most current versions of these standards, along with collaboration tools that keep teams aligned across the pharmaceutical supply chain.
In an industry where precision and safety are non-negotiable, ASTM pharmaceutical standards provide the essential framework for delivering medicines that patients and healthcare systems can trust.
ASTM Pharmaceutical Standards (Not an indication of availability in Spanish)
- ASTM E105 Practice for Probability Sampling Of Materials
- ASTM E122 Practice for Calculating Sample Size to Estimate
- ASTM E141 Practice for Acceptance of Evidence Based on the Results of Probability Sampling
- ASTM E178 Practice for Dealing With Outlying Observations
- ASTM E1325 Terminology Relating to Design of Experiments
- ASTM E1402 Guide for Sampling Design
- ASTM E2586 Practice for Calculating and Using Basic Statistics
- ASTM E3080 Practice for Regression Analysis
General Pharmaceutical Standards
- ASTM E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
- ASTM E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
- ASTM E1169 Practice for Conducting Ruggedness Tests
- ASTM E1323 Guide for Evaluating Laboratory Measurement Practices and the Statistical Analysis of the Resulting Data
- ASTM E1488 Guide for Statistical Procedures to Use in Developing and Applying Test Methods
- ASTM E2282 Guide for Defining the Test Result of a Test Method
- ASTM E2489 Practice for Statistical Analysis of One Sample and Two-Sample Interlaboratory Proficiency Testing Programs
- ASTM E2554 Practice for Estimating and Monitoring the Uncertainty of Test Results of a Test Method Using Control Chart Techniques
- ASTM E2655 Guide for Reporting Uncertainty of Test Results and Use of the Term Measurement Uncertainty in ASTM Test Methods
- ASTM E2709 Practice for Demonstrating Capability to Comply with an Acceptance Procedure
- ASTM E2782 Guide for Measurement Systems Analysis (MSA)
- ASTM E2935 Practice for Conducting Equivalence Testing in Laboratory Applications
- ASTM E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
- ASTM E1994 Practice for Use of Process Oriented AOQL and LTPD Sampling Plans
- ASTM E2234 Practice for Sampling a Stream of Product by Attributes Indexed by AQL
- ASTM E2281 Practice for Process and Measurement Capability Indices
- ASTM E2334 Practice for Setting an Upper Confidence Bound For a Fraction or Number of NonConforming items
- ASTM E2555 Practice for Factors and Procedures for Applying the MIL-STD-105 Plans in Life and Reliability Inspection
- ASTM E2587 Practice for Use of Control Charts in Statistical Process Control
- ASTM E2696 Practice for Life and Reliability Testing Based on the Exponential Distribution
- ASTM E2762 Practice for Sampling a Stream of Product by Variables Indexed by AQL
- ASTM E2819 Standard Practice for Single- and MultiLevel Continuous Sampling of a Stream of Product by Attributes Indexed by AQL
- ASTM E2910 Standard Guide for Preferred Methods for Acceptance of Product