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Karen R. Zimm, Ph.D. Temple University School of Pharmacy, Associate Director in Global Regulatory Affairs, Johnson & Johnson Innovative Medicine
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Drug Product Validation
Mark Moreno, Principal Consultant, CAI
Successful product validation depends on operational readiness: facility and equipment, development knowledge with thorough analytical and process design documentation, trained cross functional staff at the manufacturing site and a robust formulation and process. Prior to the validation phase, successful technical transfer must be completed with robust information transfer from development to manufacturing. The validation process is used to substantiate the manufacturing process documents, which contains the control strategy of the drug product and the boundary limits of the process consisting of limits of processing variables. Key process parameters (KPP), critical process parameters (CPP) and critical quality attributes (CQA) are used to define the drug product process control strategy. Validation is performed at the target parameters. All other studies to assess the boundary limits must be done prior to validation.
Overview Operational Readiness The service approach by CAI is based on Operational Readiness consisting of an integrated network for asset management, IT, commissioning and qualification, human performance, program/project management, process and manufacturing technology and regulatory compliance and quality. Utilizing this multidisciplinary oversite facilitates the achievement of a validation exercise meeting global regulatory standards. This concept by CAI staff uses established metrics and industry expectations to assure all needed information is collected and properly documented in order to execute the validation exercise with repeatability and within operating boundaries.
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Control of Nitrosamine Impurities in Human Drugs (Final, September 2024): This guidance focuses on risk assessments and control strategies for nitrosamine impurities, ensuring that manufacturers implement appropriate validation measures for preventing contamination in drug products.
Q2(R2) Validation of Analytical Procedures (Final, March 2024): This ICH guideline updates validation standards for analytical methods used during drug development and quality control, emphasizing procedure validation for accuracy, precision, specificity, and robustness.
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LIVE IN-PERSON EVENTS
Check out our calendar with conferences, webinars and on-demands trainings! |
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Transforming Software Validation With Agile CSA
Thursday, October 17, 2024 | 11:00AM – 12:15 PM ET
Presented By:
Saradha Ramamoorthy
Head, Strategic Consulting – India, Compliance Group Inc.
David .P.Deluca
Director, Strategic Consulting, Compliance Group Inc.
Senthil Gurumoorthi
Principal, Global Lead-
Healthcare & Life Sciences, Security & Compliance, Amazon Web Services
Uncovering Workstreams Of Site-Wide Readiness For Operations
Thursday, October 17, 2024 | 11:00AM – 12:15 PM ET
Presented by: Harry Benson, CAI
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October's Dose
of Knowledge
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Thriving This Fall: Essential Tips for Health, Productivity, and Focus
As the crisp autumn air sets in, staying healthy becomes a mindful seasonal endeavor. Prioritize regular physical activity and consume seasonal produce high in vitamins and nutrients to boost immunity, while also focusing on mental health by maintaining connections and a consistent sleep schedule.
Maximize your fall productivity by setting clear goals and breaking tasks into manageable steps. Organize your workspace, plan ahead using calendars or apps, and prioritize urgent tasks to stay focused during this busy season.
Sharpen your focus by creating a distraction-free environment and utilizing techniques for structured breaks. Enhance concentration by practicing mindfulness through meditation or deep breathing exercises.
By incorporating even some these strategies for health, productivity, and focus, you can navigate the fall season effectively and enter the holidays prepared and balanced.
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