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PDR & PV

PDR & PV

PDR & PV

Right PDR / PV = Less MoH Queries

Email your PDR / PV requirements to info@kridhapharma.com - We will review your requirements and revert back to you ASAP. And will also provide Quote / index on demand

Product Development Report

We Draft PDR (CTD Format)

PDR includes:

  • 3.2.P.2.1 Components of the Drug Product - Drug Substance & Drug Product
  • 3.2.P.2.3 Manufacturing Process Development
  • 3.2.P.2.4 Container Closure System
  • 3.2.P.2.5 Microbiological Attributes
  • 3.2.P.2.6 Compatibility

Dosage Form

  • Solid, Semi-solid, Liquid
  • Tablets (Immediate Release & Modified Release)
  • Capsules (Hard & Softgel)
  • Ointment / Gel
  • Solution & Powder for Injection
  • Oral Liquid / Suspension / Powder
  • Aerosol (Inhaler)

Process Valdiation

We Draft Process Valdiation Protocol and Report as per ICH guideline

PVP - Protocol includes below points:

  • Purpose of the protocol
  • Introduction – Objective, Scope, Reason for Concurrent Process Validation, Responsibilities, Reference documents
  • Description of process, Process flow diagram and Composition
  • Cleanliness zone requirements
  • Special precautionary measures
  • Evaluation of critical process parameters
  • Sampling plan and acceptance criteria

PVR - Reports includes below points:

  • Purpose of Report
  • Summary of Validation Activities
  • Deviations to Protocol
  • Description of Process, Equipment, and Testing Performed
  • Results and Discussions
  • Additional Testing and Deviations
  • Conclusions