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Risk Based Strategy for the Development & Validation of
Analytical methods with a
QbD Approach

This training module will provide the schematics of a goal oriented methods development focus with a generic, iterative and modular approach to
understand validation in general at the same time establishing the capabilities of the analytical method as the method is being developed.  The
various stages of scoping out the method initially followed by an informed strategy of design, development and optimization to arrive at the
validation parameter will be presented elaborately and lucidly.  

The guidance from USP, ICH, AOAC, EP, JP and other international standards will be discussed.

Case studies with real examples are integral parts of the training.

This very structured presentation continually builds on data handling, documentation and regulatory requirements for regulatory compliance
issues.  There is extensive guidance provided during the course for preparing validation protocols for various stages of IND, NDA and laboratory
control, QA, QC inside companies.  A brief discussion on statistical tools, SQC, SPC and stability indicating assays are included.

A scientific and mathematical rationale of Methods Transfer will also be included  with examples, the rigor of acceptance criteria, and the
development of specifications for various Drug Substances and Drug Products, Impurities, Leachables, Extractables etc. The guidelines per ICH
Q2 R(1), Q3 , USP , FDA, MEA will be included in the discussions with examples of variations.

This interactive training will be included with real examples/case histories of Development of Analytical Methods the Validation Strategies
Validation, Validation Plan and Protocol Development with class participation. Attendees are encouraged to participate especially in the class
assignments and Group Exercise.

Examples of data various levels  needed  for various Dosage forms including: Drug Substance, Drug Product, Injectables,  Parenterals,
Lypholised products, Biopharmaceutical Phase appropriate validation strategies.

Development of Stability Indicating Assays in support of ongoing Stability Studies will be touched upon.

Highlights of Topics:

  • Quality: QA/QC and Basics of Quality Systems
  • Analytical Methods and CQA’s
  • Relevance of Data and Data Integrity vs. cGMP/GLP Requirements
  • Measurement, Measurement Uncertainty and Errors
  • Understanding Methods Validation: Basic Approach vs. FDA Compliance Issues
  • Process Model in Analytical Measurement
  • Relationship of Method vs. Analytical Techniques
  • Rationale of Methods of Development and Validation: A Generic Iterative Approach in a Sequential Manner
  • Definitions: Validation Parameters, Terminology, USP, ICH Q2 R(1)
  • Basic Statistical Applications (SPC, SQC, etc.) for Data Submissions, CMC, Stability Protocols
  • Validation Guidelines (AOAC, USP, ICH, WHO, etc.) & Strategies for FDA/EMEA Compliance
  • Development of Validation Protocols and Reports for FDA
  • Analytical Development: Drug Substance, Excipients, Drug Products
  • Tables of Data Requirements for Various Dosage Forms, Injectables, Products and Applications
  • Regulatory Compliance Issues, FDA, WHO, EMEA, EPA and Other Global Guidelines
  • Qualification and Validation: Compendial Methods (USP, EP, JP)
  • Drug Development, IND, NDA, ANDA and Requirements of Various Phases for Regulatory Submissions
  • Impurities and Degradation Products, Forced Degradation, ICH
  • Optimization and Validation in HLPC, UV- VIS/PDA, LC-MS
  • Case Histories, Problem Solving, Group Participation: Develop Validation Protocol
  • Classical and Spectroscopic Methods: Limitations
  • References