GMP for ATMP - SARQA · 7. Starting and raw materials Raw materials •Consider Ph. Eur. 5.2.12...
Transcript of GMP for ATMP - SARQA · 7. Starting and raw materials Raw materials •Consider Ph. Eur. 5.2.12...
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GMP for ATMP
Advanced Therapy Medicinal Products
1© 2018 Key2Compliance AB
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Content
• Background and regualtory requirements
• GMP Walkthrough
• Quality Risk Management
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Background and regulatoryrequirements
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When???
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Medicinal products
• Classification of ATMP’s
• http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012/04/WC500126681.pdf
• If Medicinal product – GMPs apply
– And more…
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GMP applies!
ATMP withMA
ATMP used in Clinical trial
Hospital exemption
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Permit from LV also needed!
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7© 2018 Key2Compliance AB
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8© 2018 Key2Compliance AB
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GMP applies
• GMP Part IV
– (from May 22, 2018)
• Annex 1 (Sterile medicinal products)
– Draft update published
• Annex 11 (Computerised systems)
• Annex 12 (Ionisation radiation)
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GMP Walkthrough
EU GMP Guide, Part IV
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1. Introduction2. Risk-based approach3. Personnel4. Premises5. Equipment6. Documentation7. Starting and raw materials8. Seed lot and cell bank system9. Production10. Qualification and validation11. QP and batch release12. Quality Control13. Outsourced activities14. Quality defects and product recalls15. Environmental control… (GMOs)16. Reconstitution..17. Automated production of ATMPs
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1. Introduction
Scope
• Both commercialand for Clinical trials
• MA/CTA must always be followed
General principles
• Quality System and GMP
• Ensure QS is effective
• PQR for authorised ATMPs
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2. Risk-based approach
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Wait for it….
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Risk management and ATMPs
ATMPs
• Complex
• Different risks
• Inherent variability
Innovation
• Rapid changes
• Academic/hospital setting
• Different QS
Flexibility
• Early clinicalphases
• Evolvingknowledge
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Hospital AcademicIndustry
Quality
Safety
Efficacy
GMP compliance
Equal application of RBA = Risk-Based Approach
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Flexibility
Necessarycontrols/mitigations
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Level of effort and documentationcommensurate withthe level of risk!
InvestigationalATMP
AuthorisedATMP
Strategy agreed in MA
Protection of subjectsReliable test resultsConsistent with CTA
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Examples of RBA
• Raw materials
• Testing strategy
• No ”substantial manipulation”
• Investigational ATMPs
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4. Premises
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Contamination and cross-contamination
Errors
Adverse effect on quality
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5. Equipment
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7. Starting and raw materials
Raw materials
• Consider Ph. Eur. 5.2.12
• Ideal – Pharma grade
• May rely on Certificate ifrisks understood
• Biological origin – TSE!
Starting materials
• Tissues, cells – Directive2004/23/EC or 2002/98/EC
• Quality agreements
• May need to audit
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• Properly identified, labelled and stored
• Released by QC before use
• If test takes long time, may be OK to use if risks understood and mitigated
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9. Production
Phase I/II
Phase III
Authorisedproduct
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Procedures and instructions more and more detailed as knowledge increases
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9. Production
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10. Qualification and validation
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Process
Clean room
Cleaning
Test methods
Transport conditions
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11. QP and Batch release
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QP Competence
The release process – 14
items
Products with short shelf life
Unplanneddeviations and OOS
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12. Quality Control
Approval of specifications, instructions, procedures
Approvals of outsourced testing
Control of materials
Supervision of reference/retention samples
Ensure testing and evaluation of records
Stability monitoring
Participation in investigations
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13. Outsourced activities
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Contractgiver
Contractacceptor
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14. Quality defects and product recalls
CAPA system
Correction
Correctiveaction
Preventiveaction
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17. Automated production of ATMPs
Equipment suitable for intended purpose
CE mark may or may not be relevant
Qualification required
Sufficient data from equipment manufacturer
SOPs, maintenance etc.
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Thank you for your attention!