Core Roles of QA in Pharma
- GMP Compliance Ensures adherence to Positive 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.