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 Management602.12 KB 8/27/2024View
- Responding to Alarms98.59 KB 9/3/2024View
- Responding to Power Outages in Building A and B of the ATRF358.76 KB 7/24/2024View
Building and Facility Use and Maintenance
- Cleaning and Disinfection of CGMP Areas604.42 KB 7/25/2024View
- Cleaning and Disinfection of the ATRF Cell Therapy Areas2.16 MB 6/6/2024View
- Cleaning and Disinfection of the ATRF Virus Production Facility543.92 KB 6/6/2024View
- Documentation of Maintenance Work in cGMP Pharmaceutical Production Facilities109.97 KB 6/6/2024View
- Performance and Documentation of Routine Laboratory/Plant Duties - Production42.29 KB 6/6/2024View
- Pest Control for the Biopharmaceutical Development Program155.98 KB 6/6/2024View
- Sanitary Welding Documentation Guidelines92.52 KB 6/6/2024View
Equipment Calibration
- Calibration Data Review205.38 KB 7/19/2024View
- Calibration for the TOC Analyzers236 KB 5/29/2024View
- Calibration of Differential Pressure Gauges184.95 KB 5/28/2024View
- Calibration of Pressure-Measuring Devices945.83 KB 8/31/2023View
- Calibration of Temperature-Measuring Devices116.5 KB 7/24/2024View
- Equipment Calibration Program642.21 KB 10/30/2024View
Equipment Cleaning
- Cleaning and Sanitization of the Flexicon FMB210 Monoblock105.29 KB 10/30/2024View
- Cleaning Chromatography Columns for GMP Process910.58 KB 6/7/2024View
- Equipment Interproduct Cleaning and Clearance58.96 KB 5/31/2024View
- General Cleaning of Process Equipment115.97 KB 5/24/2024View
- Labeling of cGMP Purification Equipment for Cleaning Status826.73 KB 8/31/2023View
- Operation and Use of Mobile Steam Samplers290.75 KB 11/25/2024View
- Policies for Operation, Cleaning, and Routine Maintenance of Controlled Temperature Equipment250.3 KB 7/24/2024View
- Rinse Water Sampling for Production Equipment96.26 KB 5/24/2024View
- Standardization and Cleaning of 6 mm Chromatography Systems107.11 KB 8/31/2023View
Equipment Use
- Maintenance and Storage of Dissolved Oxygen and pH Probes106.23 KB 6/6/2024View
- Basic Operation of Purification Systems Running the Unicorn Control Software809.79 KB 7/25/2024View
- Design and Certification of HEPA-filtered Containment Cabinets 26104 0444.73 KB 7/24/2024View
- Equipment Logs191.83 KB 9/3/2024View
- General Policies and Procedures for Balances398.12 KB 5/28/2024View
- Instructions for Using a Peristaltic Pump986.54 KB 5/31/2024View
- Measurement of pH According to the USP Using a pH Meter127.24 KB 7/24/2024View
- Measurement of pH Using a pH Meter548.87 KB 6/7/2024View
- Operating Procedures for Automated Aseptic Filling Using the Flexicon FMB210173.2 KB 10/30/2024View
- Operation and Cleaning of the Gilson Pipetman, P-10, P-20, P-100, P-200, P-1000 Pipettes59.38 KB 5/24/2024View
- Operation and Maintenance of the Panda Bench-top Homogenizer111.95 KB 5/24/2024View
- Operation and Use of the Cassette Filter TFF Systems314.45 KB 6/5/2024View
- Operation and Use of the PLANOVA® Filtration Device613.5 KB 6/5/2024View
- Operation of the BIOSTAT STR 50-200L Bioreactor245.05 KB 8/31/2023View
- Operation of the Carr Pilot Powerfuge1.19 MB 6/7/2024View
- Operation of the Carr Pilot ViaFuge637.47 KB 8/31/2023View
- Operation of the Eppendorf BioFlo 320 benchtop bioprocess system315.66 KB 6/6/2024View
- Operation of the Flexicon FMB2001.24 MB 9/13/2024View
- Operation of the HIAC Royco 9703 Particle Counter838.55 KB 6/6/2024View
- Operation of the Sartorius Bio Welder TC231.38 KB 6/6/2024View
- Operation of the Sartorius BioSealer175.94 KB 6/6/2024View
- Operation of the Sartorius Stedim BioWelder134.76 KB 5/31/2024View
- Operation of the Sartorius STR Gen3242.06 KB 6/6/2024View
- Operation of the SMA-CA200 Pressurized Air Sampler185.49 KB 11/25/2024View
- Operation of the Thermo 7450 Controlled Rate Freezer183.71 KB 5/31/2024View
- Operation of the Thermo Scientific Sorvall Legend XFR Centrifuge535.04 KB 6/6/2024View
- Operation of the Thermo/Forma Liquid Nitrogen Storage Systems1000.6 KB 6/6/2024View
- Operation, Cleaning and Sanitization of the Gaulin Cell Homogenizer, Model 15M-8TA348.72 KB 5/31/2024View
- Packing Instructions for the BPG Series Columns340.43 KB 5/31/2024View
- Packing Instructions for the FineLine Columns626.74 KB 8/31/2023View
- Policies for Operation, Cleaning, and Routine Maintenance of Controlled Temperature Equipment250.3 KB 7/24/2024View
- Preparation of Supplies for Dry Heat (Oven), Sterilization/Depyrogenation103 KB 7/24/2024View
- Preventive Maintenance of Process Chromatography Systems112.38 KB 5/28/2024View
- Procedures for the Purification of Infectious Materials999.15 KB 6/6/2024View
- 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 Centrifuges149.35 KB 7/31/2024View
- 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 System137.29 KB 7/31/2024View
- Testing Filters with the Sartocheck 5 Integrity Test System510.91 KB 8/31/2023View
- Use and maintenance of the Agilent 2100 Bioanalyzer892.27 KB 7/24/2024View
- Use of Cross-Flow Filters276.08 KB 6/7/2024View
- Use of WFI System Points of Use276.01 KB 9/3/2024View
- Use, Cleaning and Disinfection of Equipment and Laboratories in PA/QC199.25 KB 5/31/2024View
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 Release139.75 KB 7/24/2024View
- Cell Therapy Suite Environmental Monitoring1.5 MB 9/11/2024View
- Cleaning and Disinfection of the ATRF Cell Therapy Areas2.16 MB 6/6/2024View
- Cleaning and Disinfection of the ATRF Virus Production Facility543.92 KB 6/6/2024View
- Determination of Lentivirus Transduction Efficiency with the Protein L Flow Cytometry Assay170.34 KB 6/6/2024View
- Protection of Personally Identifiable and Health Information277.88 KB 7/24/2024View
- Quantitative PCR (qPCR) Method for Detection of Replication Competent Lentivirus131.84 KB 5/30/2024View
- Testing for the Release of CliniMACS CD4 and CD8 Selection Reagents307.48 KB 7/24/2024View
- The GMP Banking Process94.45 KB 8/31/2023View
Development Operations
- Expectations for the Production of Product for Toxicology Testing223.52 KB 6/6/2024View
- Management of Project-Related Documentation92.79 KB 6/6/2024View
- 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 Facilities99.93 KB 5/24/2024View
Information for Principal Investigators
- Format and Contents of a Technology Transfer Package1.5 MB 7/31/2024View
- Project Acceptance and Completion of Projects for Clinical Use97.38 KB 5/24/2024View
Laboratory
- BDP Reference Material Management154.28 KB 5/31/2024View
- Filtration Using Disposable Bottle Filter Units154.05 KB 7/24/2024View
- Identity Testing of Raw Materials by USP Identification Tests94.62 KB 5/30/2024View
- Laboratory Notebooks Control and Use197.95 KB 5/28/2024View
- Managing Out-of-Specification Test Results or Unexpected Test Results337.21 KB 7/31/2024View
- Media Qualification Testing372.85 KB 8/31/2023View
- Sample Accessioning and Trafficking106.47 KB 7/24/2024View
Materials
- Biopharmaceutical Product Release201.91 KB 11/12/2024View
- Biopharmaceutical Quality Assurance Hold/Quarantine Policy for Materials and Products290.89 KB 6/6/2024View
- Certificate of Origin Policy for Raw Materials/Components Used at the BDP397.69 KB 7/31/2024View
- CGMP Product Accountability113.34 KB 5/31/2024View
- Handling Rejected and Expired Materials182.57 KB 6/5/2024View
- Heat Inactivation of Serum59.19 KB 8/31/2023View
- Materials Management and Inventory Control (MMIC) Program196.16 KB 5/30/2024View
- Preparation and Sterilization of Solutions191.57 KB 6/7/2024View
- Receipt and Inspection of Materials179.06 KB 5/30/2024View
- Seal Integrity Testing by Dye Intrusion Method221.79 KB 6/6/2024View
Production
Cell Culture Production
- Maintenance and Storage of Dissolved Oxygen and pH Probes106.23 KB 6/6/2024View
- Instructions for Assembly and Operation of Cell Factories520.65 KB 5/31/2024View
- Mammalian Cell Culture – Initiation and Maintenance of Cell Cultures114.83 KB 8/3/2023View
- Operation of the Sartorius Stedim BioWelder134.76 KB 5/31/2024View
- Preparation of End-Of-Production Bacterial Cell Banks168.42 KB 5/24/2024View
- Preparation of End-Of-Production Mammalian Cell Banks224.58 KB 8/3/2023View
- Qualification of Cells and CGMP Cell Banks220.15 KB 7/24/2024View
- Qualification of Mammalian Cells and Cell Banks for PA/QC Use124.45 KB 7/31/2024View
- Transfection of Mammalian Cells with Plasmid DNA381.27 KB 8/3/2023View
Contract Manufacturing
- Distribution of Products and Materials to External Recipients157.36 KB 5/31/2024View
- 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 Product103.99 KB 6/5/2024View
- Inspection of Unlabeled Vials of Finished Products190.63 KB 8/1/2024View
- Printing, Inspection, and Reconciliation of Product Labels184.2 KB 8/3/2023View
Production Identification and Documentation
- Good Documentation Practices285.89 KB 7/24/2024View
- Labeling and Storage of CGMP Raw Materials, Samples, and Equipment258.09 KB 6/5/2024View
- Laboratory Notebooks Control and Use197.95 KB 5/28/2024View
- 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
- Preparation and Sterilization of Solutions191.57 KB 6/7/2024View
- Preparation of Vials, Stoppers, and Crimps for CGMP Filling of Final Product165.97 KB 6/6/2024View
- Processing of Biological Indicators (BI) for Steam Sterilization Assurance177.83 KB 7/24/2024View
- Request for Additional Processing of Drug Substance or Final Drug Product46.8 KB 8/3/2023View
- Siliconization of Aluminum Seals118.81 KB 6/6/2024View
- Sterile Filtration of Product Using 0.2 Micron Filtration Unit53.95 KB 6/5/2024View
Vial Inspection
- Inspection of Unlabeled Vials of Finished Products190.63 KB 8/1/2024View
Quality Control
- BCA Protein Assay472.13 KB 6/6/2024View
- Desalting and Buffer Exchange of Products Using illustra NAP-5 Columns85.85 KB 7/19/2024View
- Agarose Gel Electrophoresis (A.G.E.) and Detection of Nucleic Acids261.55 KB 6/6/2024View
- Antibiotic Resistance Testing and Typing Assays for Bacterial Cell Banks228.66 KB 6/6/2024View
- Bacterial Cell Bank Viability Assay279.66 KB 7/31/2024View
- Benzonase® Activity Verification Assay183.86 KB 8/31/2023View
- Bioburden Assay by of the Membrane Filtration Method179.36 KB 7/24/2024View
- Biopharmaceutical Development Program Stability Management153.5 KB 8/1/2024View
- Calibration for the TOC Analyzers236 KB 5/29/2024View
- Cell Phenotyping by Flow Cytometry Using the Miltenyi Biotec 8-Color Immunophenotyping Kit1.06 MB 8/31/2023View
- Cell Therapy Suite Environmental Monitoring1.5 MB 9/11/2024View
- Chloramphenicol residue determination in biopharmaceutical product182.63 KB 9/11/2024View
- Creation and Control of Certificates of Analysis80.03 KB 9/13/2024View
- Culture Morphology134.85 KB 6/6/2024View
- Desalting, Buffer Exchange and Concentration of Samples Using Centrifugal Filter Devices437.71 KB 6/6/2024View
- Detection of Mycoplasma using the Vericheck ddPCR Mycoplasma Detection kit2.9 MB 11/25/2024View
- Determination of Absorbance (Optical Density) for Nucleic Acid Solutions3.36 MB 9/11/2024View
- Determination of Absorbance (Optical Density) of Protein Solutions (A280)181.7 KB 6/6/2024View
- Determination of DTE residue concentration for Biopharmaceutical Products184.79 KB 9/11/2024View
- Determination of Lentivirus Transduction Efficiency with the Protein L Flow Cytometry Assay170.34 KB 6/6/2024View
- Determination of Opalescence of a Sample Relative to a Set of Four Opalescence Reference Standards133.76 KB 5/31/2024View
- Determination of Protein Concentration by the Pierce® Coomassie Plus Assay2.44 MB 5/29/2024View
- Endotoxin Determination by Kinetic Chromogenic Testing Using Charles River LAL System1.21 MB 7/25/2024View
- Environmental and Utility Monitoring – Excursions Event Initiation and Investigation149.78 KB 8/31/2023View
- Environmental Monitoring in BDP GMP Areas6.01 MB 11/12/2024View
- Enzymatic Digestion of Protein Samples486.98 KB 6/6/2024View
- 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 Analysis102.99 KB 5/29/2024View
- HACH Free Chlorine Tests120.29 KB 5/31/2024View
- HACH Total Hardness Test Kit51.14 KB 5/29/2024View
- HPLC Technical Information Form326.92 KB 11/26/2024View
- Human IgG Subclass Isotype ELISA1.35 MB 5/31/2024View
- Identity Testing of Raw Materials by USP Identification Tests94.62 KB 5/30/2024View
- Immunodetection of Proteins Electroblotted to Membranes7.05 MB 8/31/2023View
- Infection of Mammalian Cells with Viral Vectors169.12 KB 5/30/2024View
- Isoelectric Focusing106.48 KB 8/31/2023View
- Kanamycin Residue Content Determination by LCMS187.88 KB 5/30/2024View
- lnvitrogen Gel Drying179.73 KB 6/6/2024View
- Measurement of Internal and External Dimensions Using Mitutoyo Calipers387.46 KB 5/30/2024View
- Measurement of Specific Gravity171.43 KB 5/30/2024View
- Media Qualification Testing372.85 KB 8/31/2023View
- Microbial Content110.09 KB 5/24/2024View
- Milliflex-Sensor II Coliform Assay88.07 KB 5/29/2024View
- Operation and Maintenance of the QX600 AutoDG Droplet Digital PCR system7.14 MB 11/25/2024View
- Operation of C1000 Touch Thermal Cycler339.63 KB 6/6/2024View
- Operation of the Beckman Coulter DU 800 Spectrophotometer1.11 MB 11/26/2024View
- Operation of the Gel-Pro 6.0 Analyzer Software for Densitometry947.31 KB 11/26/2024View
- Operation of the iBlot Dry Blotting System236.88 KB 5/30/2024View
- Operation of the MAS-100/MAS-100VF Air Samplers96.42 KB 11/12/2024View
- Operation of the SMA P200-03 MicroPortable Air Sampler257.99 KB 8/1/2024View
- Origination, Implementation, and Maintenance of Stability Protocols680.28 KB 8/31/2023View
- Performance of the Thermal Downshock Test92.02 KB 5/31/2024View
- Pierce Modified Lowry Protein Assay1.53 MB 5/30/2024View
- Preparation of a Gram stain: Manual Method891.42 KB 8/31/2023View
- Preventative Maintenance for the TOC Analyzers106.67 KB 7/31/2024View
- Protein Concentration Determination by Pierce‚Ñ¢ 660nm Protein Assay2.3 MB 6/6/2024View
- Purification of DNA and Viral RNA Using QIAamp Mini Kits189.88 KB 7/31/2024View
- Quantification of Nucleic Acids and Proteins with the Qubit Fluorometer 4512.97 KB 11/25/2024View
- 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 Kit1.85 MB 10/30/2024View
- Quantitation of E. coli Host Cell Protein Using the Cygnus Inc. ELISA Kit2.6 MB 5/28/2024View
- Quantitation of HEK 293 Host Cell Protein Using Cygnus Inc. ELISA Kit1.71 MB 6/20/2024View
- Quantitation of Methotrexate Using the Neogen Corporation ELISA Kit649.48 KB 5/31/2024View
- Quantitation of Protein A Using the Cyngus Inc. ELISA Kit3.63 MB 5/30/2024View
- Quantitation of Residual BSA Using the Cygnus Inc. ELISA Kit769.15 KB 5/31/2024View
- Quantitation of SP 2/0 Host Cell Protein Using the Cygnus Inc. ELISA Kit3.19 MB 7/25/2024View
- Quantitative PCR (qPCR) Method for Detection of Replication Competent Lentivirus131.84 KB 5/30/2024View
- Restriction Endonuclease Enzyme Digestion of Plasmid DNA117.72 KB 6/20/2024View
- Routine Calibration of the Waters Xevo G2-XS QToF (QToF) Mass Spectrometer2.58 MB 11/26/2024View
- Sampling, Testing, and Review of CGMP Materials by Process Analytics\Quality Control573.92 KB 11/26/2024View
- SDS Page Gel Electrophoresis Using the NuPAGE ™/Bis-Tris Gels188.43 KB 6/6/2024View
- Seal Integrity Testing by Dye Intrusion Method221.79 KB 6/6/2024View
- SilverXpress Silver Staining387.46 KB 5/31/2024View
- Solutions used in Process Analytics135.24 KB 5/31/2024View
- Spectrophotometric Viral Particle Concentration Determination of Type 5 Adenovirus228.02 KB 9/18/2024View
- Staining of Gels with Coomassie Blue R-250124.91 KB 6/6/2024View
- Staining of Gels with Sypro Ruby Protein Stain106.05 KB 5/28/2024View
- Standard Preparation for TOC Analyzer134.87 KB 7/24/2024View
- Sterility Hold53.01 KB 5/24/2024View
- Suspension Cell Based Stability Testing of Retroviral Vectors134.81 KB 10/30/2024View
- System Suitability Procedure for the TOC Analyzers148.43 KB 7/24/2024View
- System Suitability Requirements for SEC Chromatographic Methods Used in PA Laboratories153.46 KB 7/24/2024View
- Test for the Presence of Calcium in Water154.19 KB 6/6/2024View
- Testing for the Presence of Oil in Compressed Air using Drager Tube Aerotest Samplers243.56 KB 5/30/2024View
- Testing for the Release of CliniMACS CD4 and CD8 Selection Reagents307.48 KB 7/24/2024View
- The Operation of the NanoDrop ND1000 Spectrophotometer897.06 KB 10/30/2024View
- TnBP Testing on Mass Spec178.15 KB 9/11/2024View
- Use of the High Pressure Diffuser Attachment with the MET One Model 3315 Particle Counter73.63 KB 7/24/2024View
- Use of the High Pressure Diffuser Attachment with the MET One Model 3315 Particle Counter324.78 KB 11/26/2024View
- Visual Inspection of Product107.49 KB 5/31/2024View
- Western Transfer Blot104.5 KB 8/31/2023View
Quality Systems
Auditing/Oversight of Manufacturing Operations
- Assigning and Requesting Lot Numbers for Products127.67 KB 5/24/2024View
- BDP Material Review Board101.47 KB 8/31/2023View
- Biopharmaceutical Product Release201.91 KB 11/12/2024View
- Biopharmaceutical Quality Assurance Hold/Quarantine Policy for Materials and Products290.89 KB 6/6/2024View
- Corrective and Preventative Actions (CAPA) Program244.42 KB 8/31/2023View
- Deviations from Written Documents and Corrective and Preventative Actions268.38 KB 8/1/2024View
- Establishing a BDP Quality Agreement with Subcontractors166.52 KB 5/28/2024View
- GMP Area Status Management440.42 KB 8/31/2023View
- Internal CGMP Compliance Auditing203.68 KB 8/31/2023View
- Issue Review of Quality Events243.13 KB 10/30/2024View
- Policy and Operational Procedure for Contract Manufacturing by the BDP154.81 KB 8/3/2023View
- Pre-Production Clearance137.99 KB 7/31/2024View
- Quality Agreement Template238.03 KB 7/31/2023View
- Quality Assurance Operations, Responsibilities, and Authority235.56 KB 7/31/2024View
- Supplier Program Risk Analysis190.68 KB 8/31/2023View
- Supplier Qualification Program1.58 MB 8/31/2023View
- Walk-Through Inspections158.49 KB 7/31/2024View
Documentation Control
- Control and Request of Documents and Records218.08 KB 8/31/2023View
- Controlled Copies1.64 MB 11/12/2024View
- Creation and Control of Certificates of Analysis80.03 KB 9/13/2024View
- Distribution of Documents to External Recipients480.42 KB 7/25/2024View
- Document Storage and Archival Process184.92 KB 7/31/2024View
- Format, Content, and Identification of Standard Operating Procedures122.7 KB 5/28/2024View
- Good Documentation Practices285.89 KB 7/24/2024View
- Management of Project-Related Documentation92.79 KB 6/6/2024View
- 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 Documents157.01 KB 5/28/2024View
- Origination, Modification, and Control of Labeling for GMP and GLP Products1.38 MB 5/31/2024View
- Periodic / Biennial Review of SOPs235.3 KB 7/24/2024View
- 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 7/24/2024View
- Records Retention550.88 KB 8/31/2023View
Material Control
- Assignment of Part Numbers and Lot Numbers for Solutions, Buffers, and Reagents131.05 KB 11/25/2024View
- Cell Therapy Product Release139.75 KB 7/24/2024View
- Expectations for the Production of Product for Toxicology Testing223.52 KB 6/6/2024View
- Handling and Storage of CGMP Mammalian, Bacterial, and Viral Bank Materials149.86 KB 5/29/2024View
- QA Disposition of CGMP Raw Materials138.14 KB 6/6/2024View
- Requirements for Establishing Part Numbers and Specifications for BDP Components and Materials222.24 KB 8/1/2024View
- Spectrophotometric Viral Particle Concentration Determination of Type 5 Adenovirus228.02 KB 9/18/2024View
Personnel
- Alternate Signature Authority212.47 KB 8/3/2023View
- Personnel Health Restrictions in Product-Contact Environments100.31 KB 5/31/2024View
- Training and Qualification of Personnel in a CGMP Environment213.63 KB 6/6/2024View
- 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 Studies632.78 KB 5/28/2024View
- Validation Protocol, HVAC I/O/PQ Template423.95 KB 7/31/2023View
Regulatory Affairs
- Communication with Regulatory Agencies115.57 KB 6/6/2024View
- Content of an Investigational New Drug Application (IND)340.05 KB 5/30/2024View
- Establishment and Use of an FDA Electronic Submissions Gateway (ESG) Account1.4 MB 7/31/2024View
- Field Withdrawal or Correction of Investigational Products143.82 KB 5/30/2024View
- Inspections by Regulatory Agencies171.17 KB 5/31/2024View
- Preparation of Amendments to a Type V Facilities Electronic Drug Master File (CBER Format)205.39 KB 5/31/2024View
- Preparation of Manufacturing Reports559.27 KB 6/6/2024View
- Preparation of Pre-IND (Type B) Meeting Request Letters159.53 KB 7/31/2024View
- Preparation of the CMC Portion of Pre-IND Read Ahead Packages303.03 KB 6/6/2024View
- Preparing a Meeting Information Package for a Pre-IND (Type B) Meeting189.76 KB 7/24/2024View
Additional Contact Info
For any questions, issues, or other inquiries, please contact Barb Kending, project manager, at bkending@mail.nih.gov.
