Implementing Good Manufacturing Practices Current Good Manufacturing Practice (CGMP) regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure…
Conducting Risk Assessments It is commonly understood that risk is defined as the combination of the probability of occurrence of harm and the severity of that harm. Achieving a shared understanding of the application of risk management among diverse…
Establishing a Robust Quality Management System (QMS) What is a Quality Management System (QMS)? A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies…
Part 1: Understanding Regulatory Requirements In the fast-paced world of pharmaceuticals, ensuring the safety, efficacy, and quality of pharmaceutical products are paramount. Pharmaceutical quality assurance encompasses a range of activities aimed at maintaining and improving…
Applying to a Quality System Record Applying lean principles to a quality system record involves optimizing the management of documentation and data within the quality management system (QMS) to improve efficiency, reduce waste, and enhance…
Application to CAPA Implementing lean principles in corrective and preventive action (CAPA) processes involves optimizing the identification, investigation, and resolution of quality issues to prevent recurrence and improve overall efficiency. Here’s how you can apply…
Application to Design & Development Plan Database Record Lean Documents Approach: Prioritize essential information in the Design & Development Plan database record, including project objectives, milestones, deliverables, responsible personnel, and timelines. Eliminate redundant or non-essential…
Lean Documents and Configuration Approaches Lean Documents Approach: Instead of creating extensive documentation within the QSDR, prioritize essential information such as product specifications, manufacturing processes, inspection criteria, and quality control procedures. Eliminate redundant data fields…
Lean Documents and Configuration Approaches Lean Documents Approach: Instead of creating extensive documentation within the QSDR, prioritize essential information such as product specifications, manufacturing processes, inspection criteria, and quality control procedures. Eliminate redundant data fields…
Lean Documents and Configuration Approaches in a 21 CFR Part 820 QMS Lean Documents Approach: Instead of creating extensive documentation within the QSDR, prioritize essential information such as product specifications, manufacturing processes, inspection criteria, and…