How to apply new regulatory guidelines to pharmaceutical

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A guide for pharmaceutical firms applying new regulatory guideline to process validation.

A guide for pharmaceutical firms applying new regulatory guideline to process validation.

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  • 1. HOW TO APPLY NEW REGULATORY GUIDELINES TO PHARMACEUTICAL PROCESS VALIDATION
  • 2. New Expectations FDA has new expectations related to process validation through their release of Current Goods Manufacturing Processes (cGMP) that include  Process and quality controls that are more stringent  Integration of PAT (process analytical technologies) that utilize multivariate data acquisition and analysis, process analyzers, and process controls  Development of public safety programs  Expansion of industry consolidations and collaborations
  • 3. Guidelines Compliance Insight specialist Michael Goodman advises that the FDA guidelines can be met by pharmaceutical companies implementing a plan that focuses on  Using Quality-by-Design validation process and other modern approaches  Applying risk management in each area of the company  Integrating quality systems throughout the manufacturing process
  • 4. Clinical Trial Begin the first phase of a clinical trial by focusing on specific elements  qualifying equipment  designing process validation  performing an initial process validation
  • 5. Research Studies Strategically choose research studies One defines the operating range by outlining a parameter and range assessment research study and critical steps to successfully scaling-up Transparency plays important role in research to reduce tech-transfer verification at collaborator or contract-manufacturing level Life-cycle approach to process validation is recommended
  • 6. Assessing Equipment Assess all equipment and facilities to maximize process and analytical results says Goodman FDA recommends pharmaceutical manufacturing adopt risk-based analysis to accomplish this
  • 7. Equipment and Facilities To succeed follow these guidelines  Assess operations and how they influence quality  Understand equipment tolerance factors  Evaluate interaction between the systems material, in-process material and the material of which the equipment is made  Choose equipment that offers the best in accuracy and efficiency
  • 8. Validation Pharmaceutical companies need to complete at least three consecutive batches to determine validation Eliminate cross-contamination Preferred that dedication of one production line is to one single product  Not feasible for most companies Determine acceptable health-based limits on carryover  Set limits for using pharmacological and toxicological data on the last product or cleaning agent used
  • 9. Important Issue Another important issue for pharmaceutical firms is to strictly monitor and audit CMOs (contract-manufacturing companies)
  • 10. Compliance Experts Compliance Insight, Inc. Your Hands-On Quality and Regulatory Specialists Our services include GMP consulting, audit preparation, FDA mock inspections, FDA response assistance, vendor/contract audits, GMP training and accreditation, new construction compliance, regulatory consulting, investigations, biosafety and viral testing consulting; clinical trial audits and more. For more information visit http://compliance-insight1.com/