Indian pharma industry is now breathing a sigh of relief with the US FDA’s latest guidance on the analytical procedures and methods of validation for drugs and biologics. This provides recommendations ...
In pharmaceutical manufacturing, cleaning validation is an essential stage of verifying that the manufacturing process is suitable. As an integral stage of the cleaning validation program, analytical ...
DSI can supervise the development of analytical methodologies for use in the control of starting materials, drug substances, and drug products. Image Credit: DS InPharmatics This covers the complete ...
Course Topics Include: – FDA, ICH and USP Validation Requirements – Applying Validation Studies Consistent with Method Purpose – GMP Compliance during Validation – Validation Acceptance Criteria – ...
A randomized, multicenter clinical trial to determine the efficacy and safety of pegfilgrastim (GEMA BIOTECH) compared to pegfilgrastim (Roche) for prevention of chemotherapy induced neutropenia in ...
Realize safe, scalable, and compliant cell therapies by building analytical strategies that exceed regulatory expectations.
Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...
WESTPAK says its new vacuum decay CCIT service provides non-destructive, deterministic leak detection for pharmaceutical and ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results