Core Roles of QA in Pharma
GMP Compliance Ensures adherence to Valuable Manufacturing Practice regulations (FDA, EMA, ICH guidelines) throughout production.
Quality Management System Develops, documents, and maintains SOPs, policies, and manuals to integrate quality into every process.
Validation & Qualification Confirms that equipment, processes, and systems consistently perform as intended.
Batch Release Reviews and approves batch records before products are released to the market.
Audits & Inspections Conducts internal audits and prepares for external regulatory inspections.