Biopharmaceutical Development Standard Operating Procedures
The Biopharmaceutical Development Program has developed standard operating procedures for various elements and components of the biopharmaceutical development process. Tap into our library of more than 300 standard operating procedures on topics ranging from facilities best practices to quality assurance and much more.
Search or select topics and download our SOPs for your facility or cGMP activities.
Buildings/Facilities/Equipment
Building and Facility Management Policies
- Engineering Event Management1.18 MB 8/31/2023View
- Responding to Alarms144.78 KB 8/31/2023View
- Responding to Power Outages in Building A and B of the ATRF2.05 MB 8/31/2023View
Building and Facility Use and Maintenance
- Cleaning and Disinfection of the ATRF Cell Therapy Areas414.67 KB 8/31/2023View
- Cleaning and Disinfection of the ATRF Virus Production Facility255.36 KB 8/31/2023View
- Documentation of Maintenance Work in cGMP Pharmaceutical Production Facilities210.7 KB 8/31/2023View
- Performance and Documentation of Routine Laboratory/Plant Duties - Production42.29 KB 8/31/2023View
- Sanitary Welding Documentation Guidelines92.52 KB 8/2/2023View
Equipment Calibration
- Calibration Data Review205.38 KB 8/31/2023View
- Calibration for the TOC Analyzers193.49 KB 8/31/2023View
- Calibration of Differential Pressure Gauges151.19 KB 8/31/2023View
- Calibration of Pressure-Measuring Devices945.83 KB 8/31/2023View
- Calibration of Temperature-Measuring Devices181.02 KB 8/31/2023View
- Equipment Calibration Program465.08 KB 8/1/2023View
Equipment Cleaning
- Cleaning and Sanitization of the Flexicon FMB200 Monoblock165.15 KB 9/5/2023View
- Cleaning Chromatography Columns for GMP Process1.23 MB 8/31/2023View
- Equipment Interproduct Cleaning and Clearance325.23 KB 8/31/2023View
- General Cleaning of Process Equipment453.77 KB 8/31/2023View
- Instructions for Using a Peristaltic Pump986.54 KB 8/31/2023View
- Labeling of cGMP Purification Equipment for Cleaning Status826.73 KB 8/31/2023View
- Policies for Operation, Cleaning, and Routine Maintenance of Controlled Temperature Equipment282.56 KB 8/31/2023View
- Rinse Water Sampling for Production Equipment225.73 KB 8/31/2023View
- Standardization and Cleaning of 6 mm Chromatography Systems107.11 KB 8/31/2023View
Equipment Use
- Use, Cleaning and Disinfection of Equipment and Laboratories in PA/QC665.22 KB 8/31/2023View
- Design and Certification of HEPA-filtered Containment Cabinets 26104 0444.73 KB 8/1/2023View
- Digital Gel Imaging Using the Kodak 400 Image Station616.78 KB 8/31/2023View
- Equipment Logs223.14 KB 8/31/2023View
- General Policies and Procedures for Balances258.66 KB 8/31/2023View
- Maintenance and Storage of Dissolved Oxygen and pH Probes225.83 KB 8/31/2023View
- Measurement of pH According to the USP Using a pH Meter418.79 KB 8/31/2023View
- Measurement of pH Using a pH Meter548.87 KB 8/31/2023View
- Operating Procedures for Automated Aseptic Filling Using the Flexicon FMB200196.18 KB 8/31/2023View
- Operating the VHP® 1000ED-AB Generator403.88 KB 8/2/2023View
- Operation and Cleaning of the Gilson Pipetman, P-10, P-20, P-100, P-200, P-1000 Pipettes215.6 KB 8/31/2023View
- Operation and Maintenance of the Panda Bench-top Homogenizer174.59 KB 8/31/2023View
- Operation and Use of Mobile Steam Samplers739.38 KB 8/31/2023View
- Operation and Use of the Cassette Filter TFF Systems714.36 KB 8/31/2023View
- Operation and Use of the PLANOVA® Filtration Device2.09 MB 8/31/2023View
- Operation of the BIOSTAT STR 50-200L Bioreactor245.05 KB 8/31/2023View
- Operation of the Carr Pilot Powerfuge1.19 MB 8/31/2023View
- Operation of the Carr Pilot ViaFuge637.47 KB 8/31/2023View
- Operation of the Eppendorf BioFlo 320 benchtop bioprocess system315.66 KB 8/31/2023View
- Operation of the Flexicon FMB2001.24 MB 9/5/2023View
- Operation of the Sartorius Bio Welder TC231.38 KB 8/31/2023View
- Operation of the Sartorius BioSealer175.94 KB 8/31/2023View
- Operation of the Sartorius Stedim BioWelder134.44 KB 8/3/2023View
- Operation of the Sartorius STR Gen3242.06 KB 8/31/2023View
- Operation of the Thermo 7450 Controlled Rate Freezer449.26 KB 8/31/2023View
- Operation of the Thermo Scientific Sorvall Legend XFR Centrifuge535.04 KB 8/31/2023View
- Operation of Thermo/Forma Liquid Nitrogen Storage Systems972.63 KB 8/31/2023View
- Operation, Cleaning and Sanitization of the Gaulin Cell Homogenizer, Model 15M-8TA537.69 KB 8/31/2023View
- Packing Instructions for the BPG Series Columns1.11 MB 8/31/2023View
- Packing Instructions for the FineLine Columns626.74 KB 8/31/2023View
- Policies for Operation, Cleaning, and Routine Maintenance of Controlled Temperature Equipment280.93 KB 8/31/2023View
- Preparation of Supplies for Dry Heat (Oven), Sterilization/Depyrogenation208 KB 8/31/2023View
- Preventive Maintenance of Process Chromatography Systems2.03 MB 8/31/2023View
- Quantitation of Total Mouse IgG Immunoglobulin Using the Cygnus Inc. ELISA Kit2.37 MB 8/31/2023View
- Routine Use and Disinfection of Biological Safety Cabinets, Incubators, Shakers, and Centrifuges827.56 KB 8/31/2023View
- SIP and Operation of the NBS CelliGen PRO 150L Bioreactor406.35 KB 8/31/2023View
- Standard Aseptic Practices for Cleanrooms and Biological Safety Cabinets for Production Operations133.83 KB 8/31/2023View
- Standardization and Cleaning of the AKTA Pilot 600R Chromatography System193.39 KB 8/31/2023View
- Testing Filters with the Sartocheck 5 Integrity Test System510.91 KB 8/31/2023View
- Use and maintenance of the Agilent 2100 Bioanalyzer892.27 KB 8/31/2023View
- Use of Cross-Flow Filters276.08 KB 8/31/2023View
- Use of Flexible Tubing at WFI Sites179.8 KB 8/31/2023View
Cell Therapy
- 2E8 Cell Proliferation Assay for Determination of Bioactivity of rhIL-7128.78 KB 8/31/2023View
- Cell Phenotyping by Flow Cytometry Using the Miltenyi Biotec 8-Color Immunophenotyping Kit1.06 MB 8/31/2023View
- Cell Therapy Product Release376.31 KB 8/3/2023View
- Cleaning and Disinfection of the ATRF Cell Therapy Areas428.84 KB 8/31/2023View
- Cleaning and Disinfection of the ATRF Virus Production Facility255.36 KB 8/31/2023View
- Determination of Lentivirus Transduction Efficiency with the Protein L Flow Cytometry Assay732.72 KB 8/31/2023View
- Protection of Personally Identifiable and Health Information277.88 KB 8/1/2023View
- Quantitative PCR (qPCR) Method for Detection of Replication Competent Lentivirus690.33 KB 8/31/2023View
- Testing for the Release of CliniMACS CD4 and CD8 Selection Reagents307.48 KB 8/31/2023View
- The GMP Banking Process94.45 KB 8/31/2023View
Development Operations
- Expectations for the Production of Product for Toxicology Testing223.52 KB 9/5/2023View
- Expectations for the Production of Product for Toxicology Testing257.36 KB 8/3/2023View
- Format and Contents of a Technology Transfer Package1.35 MB 8/3/2023View
- Management of Project-Related Documentation174.48 KB 8/3/2023View
- Short-Term Temperature Stability Study for Products Manufactured at the BDP366.98 KB 8/3/2023View
Information for Auditors of the BDP
- Management of Sponsor Audits117.4 KB 8/31/2023View
- Policy for Visitors to the GMP Facilities86.68 KB 8/31/2023View
Information for Principal Investigators
- Distribution of Products and Materials to External Recipients366.65 KB 8/3/2023View
- Format and Contents of a Technology Transfer Package1.35 MB 8/1/2023View
- Project Acceptance and Completion of Projects for Clinical Use1.11 MB 8/1/2023View
Laboratory
- BDP Reference Material Management229.28 KB 8/31/2023View
- Filtration Using Disposable Bottle Filter Units276.03 KB 8/31/2023View
- Identity Testing of Raw Materials by USP <191> Identification Tests276.07 KB 8/31/2023View
- Laboratory Notebooks Control and Use353 KB 8/3/2023View
- Managing Out-of-Specification Test Results or Unexpected Test Results1.44 MB 8/31/2023View
- Media Qualification Testing372.85 KB 8/31/2023View
- Operation and Standardization of FACSCalibur Flow Cytometer227.15 KB 8/31/2023View
- Sample Accessioning and Trafficking301.93 KB 8/31/2023View
- Weighing of Samples for Non-GMP Use512.97 KB 8/31/2023View
Materials
- Biopharmaceutical Product Release256.03 KB 8/31/2023View
- Biopharmaceutical Quality Assurance Hold/Quarantine Policy for Materials and Products337.9 KB 8/3/2023View
- Certificate of Origin Policy for Raw Materials/Components used at the BDP608.17 KB 8/31/2023View
- CGMP Product Accountability445.79 KB 8/31/2023View
- Handling Rejected and Expired Materials219.61 KB 8/31/2023View
- Heat Inactivation of Serum59.19 KB 8/31/2023View
- Materials Management and Inventory Control (MMIC) Program322.63 KB 8/31/2023View
- Preparation and Sterilization of Solutions191.57 KB 8/3/2023View
- Receipt and Inspection of Materials860.26 KB 8/31/2023View
- Seal Integrity Testing by Dye Intrusion Method221.79 KB 8/31/2023View
Production
Cell Culture Production
- Maintenance and Storage of Dissolved Oxygen and pH Probes228.18 KB 8/3/2023View
- Instructions for Assembly and Operation of Cell Factories608.65 KB 8/3/2023View
- Mammalian Cell Culture – Initiation and Maintenance of Cell Cultures114.83 KB 8/3/2023View
- Operation of the Sartorius Stedim BioWelder134.44 KB 8/3/2023View
- Preparation of End-Of-Production Bacterial Cell Banks194.64 KB 8/3/2023View
- Preparation of End-Of-Production Mammalian Cell Banks224.58 KB 8/3/2023View
- Qualification of Cells and CGMP Cell Banks194.76 KB 8/3/2023View
- Qualification of Mammalian Cells and Cell Banks for PA/QC Use175.96 KB 8/3/2023View
- Transfection of Mammalian Cells with Plasmid DNA381.27 KB 8/3/2023View
Contract Manufacturing
- Distribution of Products and Materials to External Recipients366.65 KB 8/3/2023View
- Policy and Operational Procedure for Contract Manufacturing by the BDP154.81 KB 8/3/2023View
Packing and Labeling
- Bubble Point Test for .02 Micron Filters164.2 KB 8/3/2023View
- Inspection of Labeled Vials of Finished Product599.74 KB 8/3/2023View
- Inspection of Unlabeled Vials of Finished Products2.3 MB 8/3/2023View
- Printing, Inspection, and Reconciliation of Product Labels184.2 KB 8/3/2023View
Production Identification and Documentation
- Good Documentation Practices181.91 KB 8/3/2023View
- Labeling and Stroage of CGMP Raw Materials, Samples, and Equipment285.85 KB 8/3/2023View
- Laboratory Notebooks Control and Use353 KB 8/3/2023View
- Master Production Record Template for Bulk Aliquot, Sampling, and Storage279.58 KB 7/31/2023View
- Master Production Record Template for Final Filtration Using a 0.22 micron Filter252.39 KB 7/31/2023View
Production Materials
- Guidelines for Use of Water in Production Processes Used in the BDP130.25 KB 8/3/2023View
- Preparation and Sterilization of Solutions191.57 KB 8/3/2023View
- Preparation of Vials, Stoppers, and Crimps for CGMP Filling of Final Product1.05 MB 8/3/2023View
- Processing of Biological Indicators (BI) for Steam Sterilization Assurance177.83 KB 8/3/2023View
- Request for Additional Processing of Drug Substance or Final Drug Product46.8 KB 8/3/2023View
- Siliconization of Aluminum Seals192.26 KB 8/3/2023View
- Sterile Filtration of Product Using 0.2 Micron Filtration Unit53.02 KB 8/3/2023View
Vial Inspection
- Inspection of Unlabeled Vials of Finished Products2.3 MB 8/3/2023View
Quality Control
- Desalting and Buffer Exchange of Products Using illustra NAP-5 Columns243.93 KB 8/31/2023View
- ABI Prism 7900HT SDS Operations and Maintenance3.37 MB 8/31/2023View
- Agarose Gel Electrophoresis (A.G.E.) and Detection of Nucleic Acids229.13 KB 8/31/2023View
- Agarose Gel Electrophoresis (A.G.E.) and Detection of Nucleic Acids247.17 KB 9/5/2023View
- Antibiotic Resistance Testing and Typing Assays for Bacterial Cell Banks228.66 KB 9/5/2023View
- Antibiotic Resistance Testing and Typing Assays for Bacterial Cell Banks1.12 MB 8/31/2023View
- Asparaginase Ammonia Assay for Specific Activity398.23 KB 8/31/2023View
- Bacterial Cell Bank Viability Assay298.09 KB 8/31/2023View
- Benzonase Activity Verification Assay404.28 KB 8/31/2023View
- Benzonase® Activity Verification Assay183.86 KB 8/31/2023View
- Bioburden Assay by of the Membrane Filtration Method167.04 KB 8/31/2023View
- Biopharmaceutical Development Program Stability Management366.14 KB 8/31/2023View
- Calibration for the TOC Analyzers176.44 KB 8/31/2023View
- Catalase Assay98.46 KB 8/31/2023View
- Cell Based Stability Testing of Lentiviral Vectors490.2 KB 8/31/2023View
- Cell Phenotyping by Flow Cytometry Using the Miltenyi Biotec 8-Color Immunophenotyping Kit1.06 MB 8/31/2023View
- Coagulase Assay118.19 KB 8/31/2023View
- Culture Morphology201.21 KB 8/31/2023View
- Culture Morphology134.85 KB 9/5/2023View
- Desalting, Buffer Exchange and Concentration of Samples Using Centrifugal Filter Devices437.71 KB 9/5/2023View
- Desalting, Buffer Exchange and Concentration of Samples Using Centrifugal Filter Devices426.01 KB 8/31/2023View
- Determination of Absorbance (Optical Density) of Protein Solutions (A280)344.71 KB 8/31/2023View
- Determination of Absorbance (Optical Density) of Protein Solutions (A280)181.7 KB 9/5/2023View
- Determination of Lentivirus Transduction Efficiency with the Protein L Flow Cytometry Assay695.79 KB 8/31/2023View
- Determination of Protein Concentration by the Pierce® Coomassie Plus Assay4.39 MB 8/31/2023View
- Electrophoresis Technical Information Form373.48 KB 8/31/2023View
- Endotoxin Determination by Kinetic Chromogenic Testing Using Charles River LAL System893.28 KB 9/5/2023View
- Endotoxin Determination by Kinetic Chromogenic Testing Using Charles River LAL System893.2 KB 8/31/2023View
- Environmental and Utility Monitoring – Excursions Event Initiation and Investigation149.78 KB 8/31/2023View
- Enzymatic Digestion of Protein Samples486.98 KB 8/31/2023View
- Evaluation of the Use of HPLCH-SEC for the Detection of Aggregates in Clinical Product366.97 KB 7/26/2023View
- Freeze/Thaw Stability Study by HPLC-SEC255.86 KB 8/31/2023View
- Glassware Cleaning for Trace TOC Analysis147.17 KB 8/31/2023View
- HACH Free Chlorine Tests226.72 KB 8/31/2023View
- HACH Total Hardness Test Kit132.98 KB 8/31/2023View
- HPLC Technical Information Form537.61 KB 8/31/2023View
- Human IgG Subclass Isotype ELISA1.24 MB 8/31/2023View
- Identity Testing of Raw Materials by USP <191> Identification Tests276.07 KB 8/31/2023View
- Immunodetection of Proteins Electroblotted to Membranes7.05 MB 8/31/2023View
- Infection of Mammalian Cells with Viral Vectors1.65 MB 8/31/2023View
- Invitrogen Gel Drying102.97 KB 8/31/2023View
- Isoelectric Focusing106.48 KB 8/31/2023View
- Labeling of the 1A7 antibody with Dylight 650 fluorophore761.92 KB 8/31/2023View
- Limulus Amebocyte Lysate (LAL) Assay for Gel Clot407.03 KB 8/31/2023View
- lnvitrogen Gel Drying179.73 KB 9/5/2023View
- Measurement of Internal and External Dimensions Using Mitutoyo Calipers359.63 KB 8/31/2023View
- Measurement of Specific Gravity295.82 KB 8/31/2023View
- Media Qualification Testing372.85 KB 8/31/2023View
- Microbial Content233.48 KB 8/31/2023View
- Milliflex-Sensor II Coliform Assay226.7 KB 8/31/2023View
- Operation and Standardization of FACSCalibur Flow Cytometer196.43 KB 8/31/2023View
- Operation of the Beckman Coulter DU 800 Spectrophotometer819.27 KB 8/31/2023View
- Operation of the iBlot Dry Blotting System288.45 KB 8/31/2023View
- Operation of the MAS-100/MAS-100VF Air Samplers190.57 KB 8/31/2023View
- Operation of the Nanodrop ND1000 Spectrophotometer986.67 KB 8/31/2023View
- Operation of the SMA P200-03 MicroPortable Air Sampler867.29 KB 8/31/2023View
- Origination, Implementation, and Maintenance of Stability Protocols680.28 KB 8/31/2023View
- Oxidase Assay93.34 KB 8/31/2023View
- Performance of the Thermal Downshock Test169.05 KB 8/31/2023View
- PicoGreen dsDNA Quantitation Assay854.54 KB 8/31/2023View
- Pierce Modified Lowry Protein Assay352.32 KB 8/31/2023View
- Preparation of a Gram stain: Manual Method891.42 KB 8/31/2023View
- Preventative Maintenance for the TOC Analyzers211.94 KB 8/31/2023View
- Purification of DNA and Viral RNA Using QIAamp Mini Kits212.57 KB 8/31/2023View
- QC-Pac2 Calibration Plate for the Tecan LAL Plate Reader198.33 KB 8/31/2023View
- Quantification of Nucleic Acids and Proteins with the Qubit Fluorometer 4806.41 KB 8/31/2023View
- Quantitation of Bovine IgG Using Cygnus Inc. ELISA Kit2.41 MB 8/31/2023View
- Quantitation of CHO Host Cell Protein Using the Cygnus Inc. ELISA Kit2.92 MB 8/31/2023View
- Quantitation of E. coli Host Cell Protein Using the Cygnus Inc. ELISA Kit2.62 MB 8/31/2023View
- Quantitation of HEK 293 Host Cell Protein Using Cygnus Inc. ELISA Kit2.64 MB 8/31/2023View
- Quantitation of Methotrexate Using the Neogen Corporation ELISA Kit2.12 MB 8/31/2023View
- Quantitation of Protein A Using the Cyngus Inc. ELISA Kit3.62 MB 8/31/2023View
- Quantitation of Residual Bovine Transferrin Using the Cygnus Inc. ELISA Kit2.68 MB 8/31/2023View
- Quantitation of Residual BSA Using the Cygnus Inc. ELISA Kit1.89 MB 8/31/2023View
- Quantitative PCR (qPCR) Method for Detection of Replication Competent Lentivirus690.33 KB 8/31/2023View
- Quantitative PCR (qPCR) Methods for Detection and Quantification of Nucleic Acids618.26 KB 8/31/2023View
- Rapid Endotoxin Determination Using Charles River Portable Test System (PTS)858.23 KB 8/31/2023View
- Rapid Gram Stain ID using the Charles River Portable Test System (PTS)620.59 KB 8/31/2023View
- Restriction Endonuclease Enzyme Digestion of Plasmid DNA308.62 KB 8/31/2023View
- Restriction Endonuclease Enzyme Digestion of Plasmid DNA203.91 KB 9/5/2023View
- Sampling, Testing, and Review of CGMP Materials by Process Analytics\Quality Control353.17 KB 8/31/2023View
- Seal Integrity Testing by Dye Intrusion Method221.79 KB 8/31/2023View
- SilverXpress Silver Staining540.86 KB 8/31/2023View
- Solutions used in Process Analytics268.76 KB 8/31/2023View
- Spectrophotometric Viral Particle Concentration Determination of Type 5 Adenovirus656.35 KB 8/31/2023View
- Spectrophotometric Viral Particle Concentration Determination of Type 5 Adenovirus228.02 KB 9/5/2023View
- Staining of Gels with Sypro Ruby Protein Stain193.73 KB 8/31/2023View
- Standard Preparation for TOC Analyzer182.66 KB 8/31/2023View
- Sterility Hold275.02 KB 8/31/2023View
- System Suitability Procedure for the TOC Analyzers335.56 KB 8/31/2023View
- System Suitability Requirements for SEC Chromatographic Methods Used in PA Laboratories153.46 KB 8/31/2023View
- Test for Presence of Ammonia in Water101.82 KB 8/31/2023View
- Test for Presence of Calcium in Water44.36 KB 8/31/2023View
- Test for Presence of Oxidizable Substances in Water45.97 KB 8/31/2023View
- Test for the Presence of Calcium in Water154.19 KB 9/5/2023View
- Test for the Presence of Carbon Dioxide in Water34.69 KB 8/31/2023View
- Test for the Presence of Chloride in Water220.81 KB 8/31/2023View
- Testing for the Presence of Oil in Compressed Air using Drager Tube Aerotest Samplers379.41 KB 8/31/2023View
- Testing for the Release of CliniMACS CD4 and CD8 Selection Reagents307.48 KB 8/31/2023View
- Use of the High Pressure Diffuser Attachment with the MET One Model 3315 Particle Counter147.18 KB 8/31/2023View
- Visual Inspection of Product351.93 KB 8/31/2023View
- Western Transfer Blot104.5 KB 8/31/2023View
Quality Systems
Auditing/Oversight of Manufacturing Operations
- Assigning and Requesting Lot Numbers for Products369.1 KB 8/31/2023View
- BDP Material Review Board101.47 KB 8/31/2023View
- Biopharmaceutical Product Release256.03 KB 8/31/2023View
- Biopharmaceutical Quality Assurance Hold/Quarantine Policy for Materials and Products277.64 KB 9/5/2023View
- Biopharmaceutical Quality Assurance Hold/Quarantine Policy for Materials and Products337.9 KB 8/3/2023View
- Corrective and Preventative Actions (CAPA) Program244.42 KB 8/31/2023View
- Deviations from Written Documents and Corrective and Preventative Actions2.47 MB 8/31/2023View
- Establishing a BDP Quality Agreement with Subcontractors8.17 MB 8/31/2023View
- Field Withdrawal or Correction of Investigational Products393.72 KB 8/31/2023View
- GMP Area Status Management440.42 KB 8/31/2023View
- Internal CGMP Compliance Auditing203.68 KB 8/31/2023View
- Issue Review of Quality Events245.09 KB 8/31/2023View
- Policy and Operational Procedure for Contract Manufacturing by the BDP154.81 KB 8/3/2023View
- Pre-Production Clearance1.83 MB 8/31/2023View
- Quality Agreement Template238.03 KB 7/31/2023View
- Quality Assurance Operations, Responsibilities, and Authority1.34 MB 8/31/2023View
- Supplier Program Risk Analysis190.68 KB 8/31/2023View
- Supplier Qualification Program1.58 MB 8/31/2023View
Documentation Control
- Control and Request of Documents and Records218.08 KB 8/31/2023View
- Controlled Copies1.08 MB 8/31/2023View
- Creation and Control of Certificates of Analysis207.97 KB 8/31/2023View
- Document Storage and Archival Process362 KB 8/31/2023View
- Format, Content, and Identification of Standard Operating Procedures325.06 KB 8/31/2023View
- Good Documentation Practices181.91 KB 8/3/2023View
- Management of Project-Related Documentation172.47 KB 8/31/2023View
- Master Production Record Template for Bulk Aliquot, Sampling, and Storage279.58 KB 7/31/2023View
- Master Production Record Template for Final Filtration Using a 0.22 micron Filter252.39 KB 7/31/2023View
- Origination, Modification, and Approval of Documents430.98 KB 8/31/2023View
- Origination, Modification, and Control of Labeling for GMP and GLP Products665.39 KB 8/31/2023View
- Personnel Signature and Initial Verification System136.01 KB 8/31/2023View
- Preparation and Approval of Master Production Records1008.49 KB 8/31/2023View
- Protection of Personally Identifiable and Health Information277.88 KB 8/1/2023View
- Records Retention550.88 KB 8/31/2023View
Material Control
- Assignment of Part Numbers and Lot Numbers for Solutions, Buffers, and Reagents245.66 KB 8/3/2023View
- Biopharmaceutical Quality Assurance Hold/Quarantine Policy for Materials and Products337.9 KB 8/3/2023View
- Cell Therapy Product Release376.31 KB 8/3/2023View
- Cell Therapy Product Release396.33 KB 9/5/2023View
- Expectations for the Production of Product for Toxicology Testing250.94 KB 8/3/2023View
- Handling and Storage of CGMP Mammalian, Bacterial, and Viral Bank Materials234.79 KB 8/3/2023View
- Handling and Storage of CGMP Mammalian, Bacterial, and Viral Bank Materials184.91 KB 9/5/2023View
- QA Disposition of CGMP Raw Materials338.05 KB 8/3/2023View
- Requirements for Establishing Part Numbers and Specifications for BDP Components and Materials458.19 KB 8/3/2023View
- SDS-PAGE Gel Electrophoresis Using Tris-Glycine Gels196.98 KB 9/5/2023View
Personnel
- Alternate Signature Authority212.47 KB 8/3/2023View
- Personnel Health Restrictions in Product-Contact Environments161.44 KB 8/3/2023View
- Training and Qualification of Personnel in a CGMP Environment2.59 MB 8/3/2023View
- Training Requirements for Operators Involved in Automated Aseptic Filling Operations3.55 MB 8/3/2023View
Review/Development of Manufacturing Specifications
Validation
- Facility Validation Master Plan6.64 MB 7/26/2023View
- Use of the Kaye Validator AVS system for Qualification and Data Acquisition Studies593.29 KB 8/31/2023View
- Validation Protocol, HVAC I/O/PQ Template423.95 KB 7/31/2023View
Regulatory Affairs
- Communication with Regulatory Agencies257.71 KB 8/1/2023View
- Content of an Investigational New Drug Application (IND)340.05 KB 8/1/2023View
- Establishment and Use of an FDA Electronic Submissions Gateway (ESG) Account1.13 MB 8/1/2023View
- Field Withdrawal or Correction of Investigational Products393.96 KB 8/31/2023View
- Inspections by Regulatory Agencies431.3 KB 8/1/2023View
- Preparation of Amendments to a Type V Facilities Electronic Drug Master File (CBER Format)540.22 KB 8/1/2023View
- Preparation of Pre-IND (Type B) Meeting Request Letters208.57 KB 8/1/2023View
- Preparation of the CMC Portion of Pre-IND Read Ahead Packages207.78 KB 8/1/2023View
- Preparing a Meeting Information Package for a Pre-IND (Type B) Meeting189.76 KB 8/1/2023View
Additional Contact Info
For any questions, issues, or other inquiries, please contact Barb Kending, project manager, at bkending@mail.nih.gov.
