• Pre-process: focuses on the quality of raw materials and excipients before production begins 
• In-process: ensures that products during manufacturing processes remain consistent and meet defined specifications 
• Post-process: involves verifying the final product's quality, including its identity, potency, purity, and safety, before batch release. 

Quality assurance is a critical department in any industry, operating continuously regardless of whether production is active, to ensure ongoing regulatory compliance. Its responsibilities include tasks such as:

• Documentation and SOP: Writing and managing Standard Operating Procedures (SOPs) for all processes.

• Process Validation: Performing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

• Audits and Inspections: Conducting internal audits and inspections to ensure compliance with GMP.

• Training and Development: Training employees on quality standards and GMP requirements.

• Change Control: Managing changes in processes, equipment, or materials (Change Control).

• Deviations and CAPA: Investigating deviations and implementing Corrective and Preventive Actions (CAPA)

• Batch Release Approval: Reviewing batch records to approve or reject batches before release and ensuring that all QC testing has been satisfactorily completed.