- 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.
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