Review and highlight existing guidance documents that address pharmaceutical stability and supply chain issues. 3.) Solution
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1 Translating the Requirements of Thermal Cycling / Excursion Guidelines Through the Use of a Comprehensive Risk Management Matrix for Time and Temperature Sensitive Pharmaceutical Products Curtis Strother, Senior Technical Services Scientist & Project Manager Alyson Norrick BioConvergence
2 Review and highlight existing guidance documents that address pharmaceutical stability and supply chain issues 2.) Risk 3.) Solution 4.) Case Studies 5.) Benefit 1.) Problem Property of BioConvergence LLC 18 May
3 World Health Organization International Conference on Harmonisation TRS 953, Annex 2 TRS 937, Annex 5 Q1A(R2) U.S. Pharmacopeia <1079> Parenteral Drug Association International Society Professional Engineers Technical Report 39 Technical Report 46 Good Practice Guide Property of BioConvergence LLC 18 May
4 There is a wealth of available guidance; for some companies there may be a lack of resources to understand and apply it. The question of how to apply the guidance is a complex one, involving a number of interrelated variables Property of BioConvergence LLC 18 May
5 Potential loss of pharmaceutical product Increased Quality deviations & investigations Delayed clinical timelines Compromised clinical data Compromised efficacy and/or patient safety Property of BioConvergence LLC 18 May
6 Parameter Low Risk Medium Risk High Risk Storage / shipping temperature Ambient 15 to 25 C Shipping destination Local, 24h (ground) Contiguous US, >24h (ground / air / combo) Type of molecule Raw material / excipient Small molecule 2 to 8 C / Frozen materials OUS Large molecule / Vaccine Type of formulation Tablets / capsules Lyophilized product Solution / suspension Extent of stability data (may include TC/TE data) Long term & accelerated stability data available Short term stability data available No stability data Relative stability of molecule Stable Moderately stable Not stable Material's Quality status Non-GMP GMP, pre-clinical Material's intended use Research Toxicology / clinical trial distribution GMP, clinical or commercial Commercial distribution Property of BioConvergence LLC 18 May
7 Profile the use of the risk matrix with two different products ( real life examples) For each matrix parameter, we will assign a risk rating using scale from 1-20, with 1 being low risk Summarize the supply chain and stability solutions that we proposed using the matrix Present the post-matrix result Property of BioConvergence LLC 18 May
8 Parameter Product ABC Risk Rating Storage / shipping temperature 2 to 8 C 10 Shipping destination Domestic, air & ground 10 Type of molecule Large molecule 10 Type of formulation Parenteral solution 10 Extent of stability data (may include TC/TE data) Relative stability of molecule Accelerated stability No TC/TE Studies Stable under normal conditions, aggregates form under sheer force stress Material's Quality status GMP 5 Material's intended use Phase 1 Clinical Trial Property of BioConvergence LLC 18 May
9 Product ABC 48 Hr passive shipper Logistics Services Provider, overnight Temp monitoring Temperature Excursion Study Property of BioConvergence LLC 18 May
10 Parameter Product ABC Original Risk Rating Post-Matrix Results Storage / shipping temperature Shipping destination 2 to 8 C 10 5 Domestic, air & ground 10 5 Type of molecule Large molecule Type of formulation Parenteral solution Extent of stability data (may include TC/TE data) Relative stability of molecule Accelerated stability No TC/TE Studies Stable under normal conditions, aggregates form under sheer force stress Material's Quality status GMP 5 5 Material's intended use Phase 1 Clinical Trial Property of BioConvergence LLC 18 May
11 Parameter Product XYZ Risk Rating Storage / shipping temperature 15 to 25 C 5 Shipping destination OUS 20 Type of molecule Small molecule 5 Type of formulation Lyophilized 10 Extent of stability data (may include TC/TE data) Accelerated & Limited Long term 10 Relative stability of molecule Moderately stable 5 Material's Quality status GMP 5 Material's intended use Phase 3 Clinical Trial Property of BioConvergence LLC 18 May
12 Product XYZ 72 Hr passive shipper Clinical Material Freight Forwarder Temp monitoring Thermal Cycling/Temperature Excursion Study Property of BioConvergence LLC 18 May
13 Parameter Product XYZ Risk Rating Post-Matrix Results Storage / shipping temperature 15 to 25 C 5 1 Shipping destination OUS 20 5 Type of molecule Small molecule 5 5 Type of formulation Lyophilized Extent of stability data (may include TC/TE data) Accelerated & Limited Long term 10 5 Relative stability of molecule Moderately stable 5 5 Material's Quality status GMP 5 5 Material's intended use Phase 3 Clinical Trial Property of BioConvergence LLC 18 May
14 More predictable cost of developing a transportation control strategy More predictable product availability Clinical study/data/timeline minimally affected by temperature excursion issues Increased patient safety Property of BioConvergence LLC 18 May
15 Aug-2009, FDA Warning Letter to a clinical study sponsor, related to Temperature Excursion study Proper risk management can ensure that your project will not become a statistic such as this The Risk Matrix is a new tool Has been in use since Q Currently in use at BioC with Supply Chain clients Scope of the matrix could be expanded to include formulation development Property of BioConvergence LLC 18 May
16 QUESTIONS? Property of BioConvergence LLC 18 May
17 Curtis Strother For additional information: Property of BioConvergence LLC 18 May
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