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
Content
• Background and regualtory requirements
• GMP Walkthrough
• Quality Risk Management
© 2018 Key2Compliance AB 2
Background and regulatoryrequirements
© 2018 Key2Compliance AB 3
© 2018 Key2Compliance AB 4
When???
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…
© 2018 Key2Compliance AB 5
GMP applies!
ATMP withMA
ATMP used in Clinical trial
Hospital exemption
© 2018 Key2Compliance AB 6
Permit from LV also needed!
7© 2018 Key2Compliance AB
8© 2018 Key2Compliance AB
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)
© 2018 Key2Compliance AB 9
GMP Walkthrough
EU GMP Guide, Part IV
© 2018 Key2Compliance AB 10
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
© 2018 Key2Compliance AB 13
Wait for it….
Risk management and ATMPs
ATMPs
• Complex
• Different risks
• Inherent variability
Innovation
• Rapid changes
• Academic/hospital setting
• Different QS
Flexibility
• Early clinicalphases
• Evolvingknowledge
© 2018 Key2Compliance AB 14
© 2018 Key2Compliance AB 15
Hospital AcademicIndustry
Quality
Safety
Efficacy
GMP compliance
Equal application of RBA = Risk-Based Approach
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
Examples of RBA
• Raw materials
• Testing strategy
• No ”substantial manipulation”
• Investigational ATMPs
© 2018 Key2Compliance AB 17
4. Premises
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Contamination and cross-contamination
Errors
Adverse effect on quality
5. Equipment
© 2018 Key2Compliance AB 19
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
9. Production
Phase I/II
Phase III
Authorisedproduct
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Procedures and instructions more and more detailed as knowledge increases
9. Production
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10. Qualification and validation
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Process
Clean room
Cleaning
Test methods
Transport conditions
11. QP and Batch release
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QP Competence
The release process – 14
items
Products with short shelf life
Unplanneddeviations and OOS
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
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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© 2018 Key2Compliance AB 30
Thank you for your attention!
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