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QA Role in Pharmaceutical Industry
The document discusses the role of quality assurance (QA) in the pharmaceutical industry. QA acts as key personnel to ensure customer safety, product quality, and efficacy. QA is involved throughout the product life cycle, from design and development by authorizing documents, evaluating and auditing vendors, to manufacturing through environmental monitoring, calibration, and validation. In post-production, QA oversees stability testing, sample retention, product complaints, and recalls. QA also ensures compliance through activities like change control, deviation handling, audits, and documentation. The overall goals are to build quality into products and make quality the responsibility of all involved in manufacturing.
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QA Role in Pharmaceutical Industry
- 1. QA Role in PharmaceuticalIndustry Yosef Andreas, S.Far., Apt.
- 2.
- 3. QA Acts asKey Personnel Personil kunci mencakup kepala bagian Produksi, kepala bagian Pengawasan Mutu, dan kepala bagian Pemastian Mutu (Pedoman CPOB 2012, Bab 2 Personalia)
- 4. QA – GeneralPrinciple “Quality should be built into the product.”
- 5. Product Life Cycle Product Design& Development Manufacturing Process Post Production Compliance QA QAQA QA
- 6. Product Design andDevelopment Authorize the Document Vendor Evaluation Vendor Audit
- 7. Manufacturing Process EnvironmentalMonitoring Qualification Calibration Validation In Process Control Product Disposition
- 8. Post Production StabilityTest Retained Sample Returned Product Product Complaint Recall
- 9. Compliance Quality ManagementSystem Manual / Site Master File Change Control Deviation CAPA Audit / Self – Inspection Training Documentation Risk Management Product Quality Review
- 10. “Quality should bethe responsibility of all persons involved in manufacturing.”
- 11.
Editor's Notes
- #3 Quality should be the responsibility of all persons involved in manufacturing.
- #5 Menjamin mutu suatu produk jadi tidak hanya mengandalkan pelulusan dari serangkaian pengujian, tetapi mutu obat hendaklah dibangun sejak awal ke dalam produk tersebut
- #11 Sistem mutu berhasil diterapkan jika setiap orang yang terlibat dalam proses pembuatan obat menyadari bahwa mutu adalah tanggung jawab bersama.