QA and Regulatory

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Department of Regulatory and Quality Affairs (RQ) was founded in 1997 and has been independent of Production since then.

RQ consists of three units: Quality Assurance, Quality Control, and Validation 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, RQ 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.

Pravastatin EU GMP

FDA 2002 EIR Cover Page

FDA 2005 EIR Cover Page

FDA 2011 EIR Cover Page

FDA 2014 EIR Cover Page

Releasing or rejecting raw materials, intermediates, packaging and labeling materials, and APIs.
Reviewing completed batch production and laboratory control records of critical process steps before release of the API for distribution.
Make sure that critical deviations are investigated and resolved.
Approving procedures/changes that potentially impact intermediates or API quality.
Making sure that internal audits periodically are performed and corrective actions to audit findings are completed in a timely and effective manner.
Reviewing and approving validation protocols and reports.
Making sure that quality related complaints are investigated and resolved.
Making sure that there is stability data to support retest or expiry dates and storage conditions on intermediates and/or APIs where appropriate.
Performing product quality reviews.
Preparing/submitting DMF and its necessary update.

Products Classified by DMF, GMP certification and Inspection history

US DMF  CEP or other DMF  GMP certificate  inspected by authorities