QA
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Department of Quality Affairs has been independent of Production since then. |
| QA consists of three units: Quality Assurance, Quality Control, and Regulatory affairs that are involved in all quality-related matters in order to fulfill both quality assurance and quality control responsibilities. A quality system is in place to implement the current Good Manufacturing Practice (CFR 21 parts 210 and 211, and ICH Q7) with active participation of management and manufacturing personnel. In addition, QA also performs regulatory submissions (DMF/ASMF/CEP) in support of the successful market introduction of drug products. To date four APIs produced at CCSB have been successfully passed by the US(FDA)/European health authorities inspections. |
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Releasing or rejecting raw materials, intermediates, packaging and labeling materials, and APIs. |
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Reviewing completed batch production and laboratory control records of critical process steps before release of the API for distribution. |
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Make sure that critical deviations are investigated and resolved. |
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Approving procedures/changes that potentially impact intermediates or API quality. |
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Making sure that internal audits periodically are performed and corrective actions to audit findings are completed in a timely and effective manner. |
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Reviewing and approving validation protocols and reports. |
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Making sure that quality related complaints are investigated and resolved. |
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Making sure that there is stability data to support retest or expiry dates and storage conditions on intermediates and/or APIs where appropriate. |
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Performing product quality reviews. |
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Preparing/submitting DMF and its necessary update. |
Products Classified by DMF, GMP certification and Inspection history
