PDR & PV
Right PDR / PV = Less MoH Queries
Email your PDR / PV requirements to dhaarmi@fidesregulatory.com/ fidesraa@gmail.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 (IR & Modified)
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
