Farmakopéer: Et endringskontroll system i praksis Randi Kringstad 7. mars 2011 07.03.2011 LMI 1
Farmakopéer: Endringskontroll Hvilke farmakopéer/ Hvilke endringer Ansvarsforhold Generika/Original produkter Registrering/oppfølging/implementering av endringer Hovedmodell Quality Risk Management Oppsummering 07.03.2011 LMI 2
Pharmacopoeia- Change Control Ph.Eur. USP J. P. Chinese Pharmacopoeia Russian Pharmacopoeia 07.03.2011 LMI 3
Pharmacopoeia Change Control General Notice General Chapters General Monographs Individual Monographs Production Conditions/Requirements Storage Conditions/Requirements Many scientific area - many expects required 07.03.2011 LMI 4
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 07.03.2011 LMI 5
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) 07.03.2011 LMI 6
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 07.03.2011 LMI 7
Pharmacopoeia-Original Products Contact Person(s) in the company Qualifications Different persons for different pharmacopoeias? System to ensure continuity 07.03.2011 LMI 8
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 07.03.2011 LMI 9
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 07.03.2011 LMI 10
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 07.03.2011 LMI 11
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 07.03.2011 LMI 12
Pharmacopoeia Change Control The Review Events step is crucial to stay in regulatory compliance. 07.03.2011 LMI 13
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 07.03.2011 LMI 14
Farmakopé Takk for oppmerksomheten og Lykke til med all innsats for å levere produkter som er prøveholdig i henhold til farmakopéene. 07.03.2011 LMI 15