Quality Management Systems (QMS)

PIC/S GMP Compliance

Simpor Pharma maintains a QMS in alignment with the requirements of PIC/S GMP, encompassing:

• Quality Management
• Personnel
• Premises and Equipment
• Documentation
• Production
• Quality Control
• Contract Manufacture and Analysis (where applicable)
• Complaints and Product Recall
• Self Inspection

Core Elements

The core elements of Simpor’s QMS include:

• Change Control
• Document and Records Management
• Training
• Product Quality Review
• Quality Risk Management
• Equipment Qualification and Validation
• Process and Cleaning Validation
• Analytical Method Validation
• Stability
• Sampling and Analysis
• Management of Retention Samples