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General Biopharmaceutical Standards General Pharmaceutical Standards Lyophilization Process Understanding and PAT System Management, Implementation and Practice Terminology

General Biopharmaceutical Standards

E2097-00(2014) Standard Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products (Withdrawn 2022)

E3042-16 Standard Practice for Process Step to Inactivate Rodent Retrovirus with Triton X-100 Treatment

E1564-00(2019) Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials

E1566-00(2019) Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen

E1565-00(2019) Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures

E2888-12(2019) Standard Practice for Process for Inactivation of Rodent Retrovirus by pH

E3231-19 Standard Guide for Cell Culture Growth Assessment of Single-Use Material

E3244-20 Standard Practice for Integrity Assurance and Testing of Single-Use Systems

E3230-20 Standard Practice for Extraction of Particulate Matter from the Surfaces of Single-Use Components and Assemblies Designed for Use in Biopharmaceutical Manufacturing

E1286-00(2006) Standard Guide for Identification of Herpes Simplex Virus or Its DNA (Withdrawn 2014)

E1532-00(2006) Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Use of Bisbenzamide DNA-Binding Fluorochrome (Withdrawn 2014)

E1536-00(2006) Standard Practice for Detection of Mycoplasma Contamination of Bovine Serum by Large Volume Method (Withdrawn 2014)

E1873-06 Standard Guide for Detection of Nucleic Acid Sequences by the Polymerase Chain Reaction Technique (Withdrawn 2014)

E1759-95(2003) Standard Test Method for Isoaspartic Acid in Proteins: Method for the Determination of Asparagine Deamidation Products (Withdrawn 2003)

E1470-92(2006) Standard Test Method for Characterization of Proteins by Electrophoretic Mobility (Withdrawn 2014)

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of the Mycobacterium Tuberculosis Complex and Other Pathogenic Mycobacteria by the Polymerase Chain Reaction Technique (Withdrawn 2014)

E1298-06 Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)

E1531-00(2006) Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Growth on Agarose Medium (Withdrawn 2014)

E1285-06 Standard Guide for Identification of Bacteriophage Lambda (λ) or Its DNA (Withdrawn 2014)

E1533-00(2006) Standard Practice for Indirect Detection of Mycoplasma in Cell Culture by 4`-6-Diamidino-2-2 Phenylindole (DAPI) Staining (Withdrawn 2014)

E1493-06 Standard Guide for Identification of Bacteriophage M13 or Its DNA (Withdrawn 2014)

E3336-22 Standard Test Method for Physical Integrity Testing of Single-Use Systems

E3326-22 Standard Guide for Application of Continuous Manufacturing (BioCM) in the Biopharmaceutical Industry

E3259-22 Standard Practice for Process to Remove Retroviruses by Small Virus Retentive Filters

E3251-23 Standard Test Method for Microbial Ingress Testing on Single-Use Systems

General Pharmaceutical Standards

E2500-20 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

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

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

E2537-16 Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing

E3077-17e2 Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers

E2810-19 Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units

E2503-13(2020) Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus

E3219-20 Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)

F838-20 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration

E3106-22 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation

E3263-22e1 Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues

Lyophilization

E3250-21 Standard Practice for Product Temperature and Equipment Pressure Instrumentation in Pharmaceutical Freeze Drying

Process Understanding and PAT System Management, Implementation and Practice

E2629-20 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems

E2475-10(2016) Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

E3177-18 Standard Guide on Sampling for Process Analytical Technology

E2474-14 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020)

E2891-20 Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications

E2898-20a Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications

E2476-22 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture

E2968-23 Standard Guide for Application of Continuous Manufacturing (CM) in the Pharmaceutical Industry

Terminology

E2363-23 Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry