Knowledge Centre
FDA Warning Letter: Prevention OR Remediation
An FDA warning letter (WL) is issued when the FDA finds significant problems with the quality, safety, or efficacy of drug...
PAI Readiness for Outsourced Operations
As the product moves from clinical development to commercial manufacturing, regulatory landscapes change. At the clinical...
Quality Management Maturity (QMM)
A Journey from Basic cGMP to Optimized Quality Maturity The most recently proposed CDER QMM initiative has drawn curiosity and...
CDMO Risk Management: High-Risk vs Low-Risk CDMO
From a regulatory standpoint, Sponsors are required to conduct a risk assessment or qualification audit during the CDMO...
Quality Systems for Outsourced Operations Oversight
Many drug manufacturers (owners) outsource different parts of manufacturing operations to bring products to market faster and at...
Phase Appropriate (Risk Based) Quality Systems
It is important to implement phase-appropriate quality (risk-based) systems starting from product development in R&D,...
Quality Strategic Planning
Organizations continuously face challenges related to quality improvements. Management trains front-line and quality management...
Writing 483 Response
Writing 483 Response can be a stressful process. However, it is beneficial to follow a systemic process to ensure that the...
Data Integrity
Regulators around the globe have issued guidance on data integrity in the last five years. As per FDA guidance, “Data integrity...
Trending Program for OOS Investigation
FDA guidance for handling OOS results was updated in May 2022 and is available on the FDA website. This guidance provides...
Sponsors’ Responsibility for GLP Studies
GLP (Good Laboratory Practices) is a quality system for organizational processes and management controls under which...