Farmakopéer: Et endringskontroll system i praksis

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Alvin Mason
10 years ago
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1 Farmakopéer: Et endringskontroll system i praksis Randi Kringstad 7. mars LMI 1

2 Farmakopéer: Endringskontroll Hvilke farmakopéer/ Hvilke endringer Ansvarsforhold Generika/Original produkter Registrering/oppfølging/implementering av endringer Hovedmodell Quality Risk Management Oppsummering LMI 2

Registrering/oppfølging/implementering av endringer

3 Pharmacopoeia- Change Control Ph.Eur. USP J. P. Chinese Pharmacopoeia Russian Pharmacopoeia LMI 3

4 Pharmacopoeia Change Control General Notice General Chapters General Monographs Individual Monographs Production Conditions/Requirements Storage Conditions/Requirements Many scientific area - many expects required LMI 4

Production Conditions/Requirements Storage

5 Pharmacopoeia Review Group(s) Knowledge of product portefolio Experts from different area Phase of Change proactive/reactive Assessment- Change Control Commitee(s) Action- implementation of decision LMI 5

Change proactive/reactive Assessment- Change Control

6 Pharmacopoeia Compliance - Responsibilities Holder of NDA/MA s Management responsibility to ensure compliance to pharmacopoeias Need to be defined in the Pharmaceutical Quality Assurance System Need to be defined in Job Descriptions Knowledge Management (Q10) LMI 6

Need to be defined in the Pharmaceutical Quality Assurance System

7 Generics- Original Products Generics Individual Monograph exists - according to current pharmacopoeia Original Products No Individual Monograph exists - cooperation with Pharm. Commissions during establishmented/revision - Monograph in MA/NDA, Pharmacopoeia and QC Practice need to be equivalent LMI 7

8 Pharmacopoeia-Original Products Contact Person(s) in the company Qualifications Different persons for different pharmacopoeias? System to ensure continuity LMI 8

9 Risk Communication A General Quality Risk Management Process From ICH Initiate Quality Risk Management Process Risk Assessment Risk Identification Risk Analysis Risk Control Risk Evaluation Risk Reduction Risk Acceptance unacceptable Risk Management tools Output / Result of the Quality Risk Management Process Risk Review Review Events LMI 9

Risk Evaluation Risk Reduction Risk Acceptance unacceptable Risk Management tools Output

10 Risk Communication Original Products - New/Revised Individual Monographs Request Initiate Quality Risk Management Process Risk Assessment Evaluation/ Assessment Risk Identification Risk Analysis Control/ Conclusion Output/response Risk Control Risk Evaluation Risk Reduction Risk Acceptance Output / Result of the Quality Risk Management Process unacceptable Risk Management tools Review Commission Conclusion Risk Review Review Events LMI 10

Output/response Risk Control Risk Evaluation Risk Reduction Risk Acceptance Output / Result of the Quality Risk

11 When to apply Quality Risk Management? CONSIDERATIONS Should risks be assessed? Are there clear rules for decision making? e.g. regulations No or justification needed 1. What might go wrong? 2. What is the likelihood (probability) it will go wrong? 3. What are the consequences (severity)? Yes no RM Can you answer the risk assessment questions? Yes informal RM No formal RM Agree on a team (small project) Risk assessment not required (No flexibility) Initiate Risk assessment (risk identification, analysis & evaluation) Select a Risk Management tool (if appropriate e.g. see ICH Q9 Annex I) Follow procedures (e.g. Standard Operating Procedures) Run risk control (select appropriate measures) Carry out the quality risk management process Document results, decisions and actions Document the steps LMI 11

Yes informal RM No formal RM Agree on a team (small project) Risk assessment not required (No flexibility) Initiate Risk assessment (risk identification, analysis & evaluation) Select a Risk

12 Risk Communication Original Products - New/Revised Individual Monographs Request Initiate Quality Risk Management Process Risk Assessment Evaluation/ Assessment Risk Identification Risk Analysis Control/ Conclusion Output/response Risk Control Risk Evaluation Risk Reduction Risk Acceptance Output / Result of the Quality Risk Management Process unacceptable Risk Management tools Review Commission Conclusion Risk Review Review Events LMI 12

13 Pharmacopoeia Change Control The Review Events step is crucial to stay in regulatory compliance LMI 13

14 Farmakopé - Endringer Oppsummering For å være i regulatorisk compliance er det nødvendig å ha: - Definert og beskrevet endringskontrollsystem - Tilstrekkelig kompetanse til konsekvensvurdering - Ansvarsforhold nedfelt i arbeidsbeskrivelser LMI 14

endringskontrollsystem - Tilstrekkelig kompetanse til

15 Farmakopé Takk for oppmerksomheten og Lykke til med all innsats for å levere produkter som er prøveholdig i henhold til farmakopéene LMI 15

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Q4B ANNEX 12

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL