RAPS

ICH releases draft guidelines on analytical method development

ICH releases draft guidelines on analytical method development The International Council for Harmonization (ICH) on Thursday issued two draft guidelines that should make it easier for manufacturers to ...
RAPS

Convergence: New ICH Q1 guideline is ‘one-stop shop’ for stability testing

PITTSBURGH — The new International Council for Harmonisation (ICH) Q1 draft guideline on stability testing of drug substances and drug products is an attempt to revise the current ICH Q1 guideline, ...
PharmTech

Evolution of Analytical Procedure Validation Concepts: Part II– Incorporation of Science and Risk-based Principles in ICH Q14 and Q2(R2) Guidelines

No additional expectations or mandated requirements are expected in Q14, Q2(R2) and USP <1220>. The minimal approach can still be used. Q14 and Q2(R2) are consistent with the principles described in ...
Pharmabiz

Experts recommend ICH guidelines on pharma quality for implementation of revised Schedule M

Experts have recommended ICH Q10 PQS (International Council for Harmonisation - Pharmaceutical Quality System) guidelines on pharma quality systems for effective implementation of revised Schedule M ...