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Pharmaceutical Application Standards


ASTM's pharmaceutical application standards cover process control, design, and performance, as well as quality acceptance/assurance tests for the pharmaceutical manufacturing industry. These pharmaceutical application standards are valuable to manufacturers of pharmaceuticals and pharmaceutical equipment, federal agencies, design professionals, professional societies, trade associations, financial organizations, and academia.


List of pharmaceutical application standards developed by ASTM:

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General Biopharmaceutical Standards
DesignationTitle
E1285 - 06 Standard Guide for Identification of Bacteriophage Lambda (λ) or Its DNA
E1286 - 00(2006) Standard Guide for Identification of Herpes Simplex Virus or Its DNA
E1298 - 06 Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products
E1470 - 92(2006) Standard Test Method for Characterization of Proteins by Electrophoretic Mobility
E1493 - 06 Standard Guide for Identification of Bacteriophage M13 or Its DNA
E1531 - 00(2006) Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Growth on Agarose Medium
E1532 - 00(2006) Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Use of Bisbenzamide DNA-Binding Fluorochrome
E1533 - 00(2006) Standard Practice for Indirect Detection of Mycoplasma in Cell Culture by 4`-6-Diamidino-2-2 Phenylindole (DAPI) Staining
E1536 - 00(2006) Standard Practice for Detection of Mycoplasma Contamination of Bovine Serum by Large Volume Method
E1564 - 00(2006) Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials
E1565 - 00(2006) Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures
E1566 - 00(2006) Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen
E1873 - 06 Standard Guide for Detection of Nucleic Acid Sequences by the Polymerase Chain Reaction Technique
E2048 - 99(2006) Standard Guide for Detection of Nucleic Acids of the Mycobacterium Tuberculosis Complex and Other Pathogenic Mycobacteria by the Polymerase Chain Reaction Technique
E2097 - 00(2006) Standard Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products
General Pharmaceutical Standards
DesignationTitle
E2500 - 07(2012) Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
E2503 - 07 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
E2656 - 10 Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute
E2810 - 11 Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units
PAT System Management, Implementation and Practice
DesignationTitle
E2474 - 06 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology
E2475 - 10 Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
E2476 - 09 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
E2629 - 11 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
Terminology
DesignationTitle
E2363 - 06a Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry


Other standards developed by ASTM committees:

3D Imaging Standards

Additive Manufacturing Standards

Adhesive Standards

Aerospace Material Standards

Analytical Chemistry Standards

Asset Management Standards

Atmospheric Analysis Standards

Biotechnology Standards

Construction Standards

Adhesive Standards

Building Standards

Cement Standards and Concrete Standards

Fire Standards and Flammability Standards

Geotechnical Engineering Standards

Masonry Standards

Road Standards and Paving Standards

Roofing Standards

Thermal Insulation Standards

Wood Standards

Business Copy Product Standards

Carbon Standards

Catalyst Standards

Cement Standards and Concrete Standards

Coal Standards and Gas Standards

Composite Standards

Computerized System Standards

Consumer Product Evaluation Standards

Copper Standards

Corrosion Standards and Wear Standards

Durability of Nonmetallic Material Standards

Electrical Insulating Material Standards

Electrical Standards and Magnetic Conductor Standards

Electronics Standards

Environmental Standards

Atmospheric Analysis Standards

Environmental Assessment Standards and Risk Management Standards

Environmental Toxicology Standards

Waste Management Standards

Water Testing Standards

Fastener Standards

Fatigue Standards and Fracture Standards

Fire Standards and Flammability Standards

Forensic Science Standards

Geotechnical Engineering Standards

Glass Standards and Ceramic Standards

Industrial Chemical Standards

Industrial Hygiene Standards and Safety Standards

Laboratory Testing Standards

Leather Standards

Masonry Standards

Medical Device Standards and Implant Standards

Medical Service Standards and Medical Equipment Standards

Metals Standards

Analytical Chemistry Standards

Cast Iron Standards

Copper Standards

Corrosion Standards and Wear Standards

Fastener Standards

Fatigue Standards and Fracture Standards

Metallic Coating Standards

Nonferrous Metal Standards and Nonferrous Alloy Standards

Steel Standards

Molecular Spectroscopy Standards and Separation Science Standards

Nanotechnology Standards

Nondestructive Testing Standards

Nuclear Technology Standards

Oxygen Enriched Atmospheres Standards

Paint Standards and Related Coating Standards

Paper Standards and Packaging Standards

Petroleum Standards

Pharmaceutical Application Standards

Physical Measurement Standards

Physical Testing Standards and Mechanical Testing Standards

Plastic Pipe Standards

Plastics Standards

Quality Control Standards

Refractory Standards

Resilient Floor Covering Standards

Road Standards and Paving Standards

Rolling Element Bearing Standards

Roofing Standards

Rubber Standards

Search and Rescue Operations Standards

Security System Standards and Pedestrian / Walkway Safety Standards

Sensory Evaluation Standards

Soap Standards and Polish Standards

Sports Standards and Recreation Standards

Steel Standards

Sustainability Standards

Temperature Measurement Standards

Textile Standards

Thermal Analysis Standards

Thermal Insulation Standards

Underground Utility Standards

Unmanned Maritime Vehicle Standards

Waste Management Standards

Water Testing Standards

Wood Standards