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CGTP governs the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps including all steps in recovery, donor screening, donor testing, processing, storage, labeling, packaging, and distribution. https://www.aretezoe.com/
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current Good Tissue Practice
- 1. CGTP governs the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps including all steps in recovery, donor screening, donor testing, processing, storage, labeling, packaging, and distribution. ENVIRONMENTFACILITIES EQUIPMENT SUPPLIES REAGENTS PROCESSRECOVERY LABELLING STORAGE DONORSDISTRIBUTION CURRENT GOOD TISSUE PRACTICE 21 CFR 1271: CGTP https://www.aretezoe.com/ 102/29/2016
- 2. 21 CFR 1271: CGTP CURRENT GOOD TISSUE PRACTICE PERSONNEL: Manufacturer must have sufficient, competent and appropriately trained personnel to ensure compliance. ENVIRONMENTFACILITIES EQUIPMENT SUPPLIES REAGENTS PROCESSRECOVERY LABELLING STORAGE DONORSDISTRIBUTION https://www.aretezoe.com/ 202/29/2016
- 3. 21 CFR 1271: CGTP CURRENT GOOD TISSUE PRACTICE PROCEDURES: Procedures appropriate to meet core CGTP requirements for all manufacturing steps and design these procedures to prevent circumstances that increase the risk of the introduction, transmission, or spread of communicable diseases ENVIRONMENTFACILITIES EQUIPMENT SUPPLIES REAGENTS PROCESSRECOVERY LABELLING STORAGE DONORSDISTRIBUTION https://www.aretezoe.com/ 302/29/2016
- 4. ENVIRONMENTFACILITIES EQUIPMENT SUPPLIES REAGENTS PROCESSRECOVERY LABELLING STORAGE DONORSDISTRIBUTION 21 CFR 1271: CGTP CURRENT GOOD TISSUE PRACTICE QUALITY PROGRAMS • Manufacturer must establish and maintain a quality program • Procedures must be reviewed, approved and revised as appropriate. • Procedures for receiving, investigating, evaluating, and documenting core CGTP requirements, including complains and possible contaminations • Provisions on risk assessment and appropriate follow-up (recall, FDA reporting) • CAPA, audits, re-audits, deviations from procedure, monitoring systems • Training and education • Validated performance of computer software https://www.aretezoe.com/ 402/29/2016
- 5. ENVIRONMENTFACILITIES EQUIPMENT SUPPLIES REAGENTS PROCESSRECOVERY LABELLING STORAGE DONORSDISTRIBUTION 21 CFR 1271: CGTP CURRENT GOOD TISSUE PRACTICE FACILITIES: • Suitable size, construction, and location • Clean, sanitary, and orderly • Operations: control systems to prevent improper labeling, mix-ups, contamination, cross- contamination, and accidental exposure to communicable disease agents. https://www.aretezoe.com/ 502/29/2016
- 6. ENVIRONMENTFACILITIES EQUIPMENT SUPPLIES REAGENTS PROCESSRECOVERY LABELLING STORAGE DONORSDISTRIBUTION 21 CFR 1271: CGTP CURRENT GOOD TISSUE PRACTICE ENVIRONMENTAL CONTROL: • Temperature and humidity controlled via ventilation and air filtration • Cleaning and disinfecting of rooms and equipment to ensure aseptic operations • Maintenance of equipment used to control aseptic conditions https://www.aretezoe.com/ 602/29/2016
- 7. ENVIRONMENTFACILITIES EQUIPMENT SUPPLIES REAGENTS PROCESSRECOVERY LABELLING STORAGE DONORSDISTRIBUTION 21 CFR 1271: CGTP CURRENT GOOD TISSUE PRACTICE EQUIPMENT • Appropriate design, suitable location and installation • Must produce valid results. • Must be properly maintained, sanitized, calibrated and routinely inspected https://www.aretezoe.com/ 702/29/2016
- 8. ENVIRONMENTFACILITIES EQUIPMENT SUPPLIES REAGENTS PROCESSRECOVERY LABELLING STORAGE DONORSDISTRIBUTION 21 CFR 1271: CGTP CURRENT GOOD TISSUE PRACTICE SUPPLIES AND REAGENTS • Verified supplies and reagents that meet specifications • Production of in-house reagents must be validated • Records and receipts of al operations, equipment, supplies and reagents https://www.aretezoe.com/ 802/29/2016
- 9. ENVIRONMENTFACILITIES EQUIPMENT SUPPLIES REAGENTS PROCESSRECOVERY LABELLING STORAGE DONORSDISTRIBUTION 21 CFR 1271: CGTP CURRENT GOOD TISSUE PRACTICE RECOVERY Establishment that recover HCT/Ps, must do so in a way that does not cause contamination or cross- contamination during recovery. https://www.aretezoe.com/ 902/29/2016
- 10. ENVIRONMENTFACILITIES EQUIPMENT SUPPLIES REAGENTS PROCESSRECOVERY LABELLING STORAGE DONORSDISTRIBUTION 21 CFR 1271: CGTP CURRENT GOOD TISSUE PRACTICE PROCESSING AND PROCESS CONTROLS • Prevent contamination or cross- contamination Do not pool cells or tissue from different donors • Representative in-process control and testing Dura mater: validated process to prevent CJD • Any change to a process must be verified or validated and approved before implementation by a responsible person. • Changes have to be communicated to staff. https://www.aretezoe.com/ 1002/29/2016
- 11. ENVIRONMENTFACILITIES EQUIPMENT SUPPLIES REAGENTS PROCESSRECOVERY LABELLING STORAGE DONORSDISTRIBUTION 21 CFR 1271: CGTP CURRENT GOOD TISSUE PRACTICE PROCESS VALIDATION • Validation activities and results must be documented and signed off • Any written representation must be based on a fully verified or validated process. • Changes in process must be validated, and process revalidated. https://www.aretezoe.com/ 1102/29/2016
- 12. ENVIRONMENTFACILITIES EQUIPMENT SUPPLIES REAGENTS PROCESSRECOVERY LABELLING STORAGE DONORSDISTRIBUTION 21 CFR 1271: CGTP CURRENT GOOD TISSUE PRACTICE LABELLING • Establish and maintain procedures • Ensure identification, prevent mix-ups • Verify accuracy, legibility and integrity • Donor eligibility • Type of HCT/P • Expiration date, storage temperature • Warnings if applicable • Instructions for use • Name and address of the establishment https://www.aretezoe.com/ 1202/29/2016
- 13. ENVIRONMENTFACILITIES EQUIPMENT SUPPLIES REAGENTS PROCESSRECOVERY LABELLING STORAGE DONORSDISTRIBUTION 21 CFR 1271: CGTP CURRENT GOOD TISSUE PRACTICE STORAGE • Control storage areas and stock rooms to prevent mix- ups, contamination, and unapproved release • Appropriate temperature • Expiration dates • Any corrective actions documented https://www.aretezoe.com/ 1302/29/2016
- 14. ENVIRONMENTFACILITIES EQUIPMENT SUPPLIES REAGENTS PROCESSRECOVERY LABELLING STORAGE DONORSDISTRIBUTION 21 CFR 1271: CGTP CURRENT GOOD TISSUE PRACTICE RECEIPT, DISTRIBUTION • Evaluate each incoming HCT/P • Pre-established criteria Determine: • Accept • Reject • Quarantine • Pre-distribution: HCT/P not available for distribution must be shipped in quarantine. https://www.aretezoe.com/ 1402/29/2016
- 15. ENVIRONMENTFACILITIES EQUIPMENT SUPPLIES REAGENTS PROCESSRECOVERY LABELLING STORAGE DONORSDISTRIBUTION 21 CFR 1271: CGTP CURRENT GOOD TISSUE PRACTICE RECEIPT, DISTRIBUTION • Pre-distribution: HCT/P not available for distribution must be shipped in quarantine. • Availability for distribution: release criteria have been met, shipment signed off • Packaging and shipping: establish appropriate shipping conditions • Procedures: release criteria, identification, audit trail for all activities, quantity of HCT/P subject, disposition of the HCT/P, and return to inventory. • Traceability: HCT/P must be traceable. https://www.aretezoe.com/ 1502/29/2016
- 16. ENVIRONMENTFACILITIES EQUIPMENT SUPPLIES REAGENTS PROCESSRECOVERY LABELLING STORAGE DONORSDISTRIBUTION 21 CFR 1271: CGTP CURRENT GOOD TISSUE PRACTICE RECORDS • Maintain records of each step as required • Accurate, indelible, and legible, identifiable and retrievable • Identify Responsible Person • Records management system • Records must be retained for 10 years • Contracts and agreements must be kept. https://www.aretezoe.com/ 1602/29/2016
- 17. ENVIRONMENTFACILITIES EQUIPMENT SUPPLIES REAGENTS PROCESSRECOVERY LABELLING STORAGE DONORSDISTRIBUTION 21 CFR 1271: CGTP CURRENT GOOD TISSUE PRACTICE EXEMPTIONS AND ALTERNATIVES • Exemptions may be requested • Provide justification and alternative Operation under exemption or alternative can only begin once granted. https://www.aretezoe.com/ 1702/29/2016
- 18. ENVIRONMENTFACILITIES EQUIPMENT SUPPLIES REAGENTS PROCESSRECOVERY LABELLING STORAGE DONORSDISTRIBUTION 21 CFR 1271: CGTP CURRENT GOOD TISSUE PRACTICE COMPLAINT FILE Maintain, record, and review complaints https://www.aretezoe.com/ 1802/29/2016
- 19. ADVERSE REACTIONS • Non-reproductive only • Manufacturers must investigate and follow-up any adverse reaction involving a communicable disease related to an HCT/P that it made available for distribution. • Adverse reactions are reportable to FDA if: • fatal; • life-threatening; • result in permanent impairment or permanent damage • necessitate medical or surgical intervention, including hospitalization. Form FDA-3500A within 15 calendar days (Guidance for industry) 21 CFR 1271: CGTP REPORTING, IMPORT, INSPECTIONS https://www.aretezoe.com/ 1902/29/2016
- 20. BIOLOGICAL PRODUCT DEVIATION REPORT Manufacturers must report HCT/P deviations relating to the core CGTP requirements within 45 days of discovery 21 CFR 1271: CGTP REPORTING, IMPORT, INSPECTIONS Form FDA-3486 Guidance for industry https://www.aretezoe.com/ 2002/29/2016
- 21. 21 CFR 1271: CGTP REPORTING, IMPORT, INSPECTIONS INSPECTIONS Establishment that manufactures HCT/Ps must permit the FDA to inspect its facilities, equipment, finished and unfinished materials, containers, processes, HCT/Ps, procedures, labeling, records, files, and papers. https://www.aretezoe.com/ 2102/29/2016
- 22. 21 CFR 1271: CGTP REPORTING, IMPORT, INSPECTIONS IMPORT The importer must notify the FDA which the HCT/P is offering for import Exceptions include reproductive HCT/Ps of the PHSA and to peripheral blood stem/progenitor cells regulated solely under section 361. https://www.aretezoe.com/ 2202/29/2016
- 23. 21 CFR 1271: CGTP REPORTING, IMPORT, INSPECTIONS RETENTION, RECALL, DESTRUCTION, CESSATION OF MANUFACTURING • written order that the HCT/P be recalled and/or destroyed • take possession of and/or destroy the violative HCT/P https://www.aretezoe.com/ 2302/29/2016