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HOW TO APPLY NEW REGULATORY
        GUIDELINES TO
   PHARMACEUTICAL PROCESS
          VALIDATION
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
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
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
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
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
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
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
Important Issue

 Another important issue for pharmaceutical
  firms is to strictly monitor and audit CMOs
  (contract-manufacturing companies)
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/

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How to apply new regulatory guidelines to pharmaceutical

  • 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/