Prosperity 6 Pharmaceutics

Elements of the Quality system

QA system is overall responsible for meeting the Quality of the finished product. It has a separate QC section concerned with the sampling, specification, testing, documentation and release procedures for incoming, semi finished and finished products. Quality control ensures that the necessary and relevant tests are carried out and only those materials which are meeting the quality are released for use.
QC monitors the stability of the product as per the ICH guidelines.
The functional responsibility of the QA and QC have been allocated as follows:

Functions
Quality Assurance Department	Quality Control Department
cGMP implementation Validation Self inspection Market complaints Vendor evaluation Training Document review Process non-conformity review and approval Investigation Product recall Document control / Change control Regulatory requirements Deviations review and approval Qualification of equipment’s Final batch release Stability assessment and approval GMP Monitoring	GLP implementation Sampling Testing Approval/rejection as per the test status. Method validation Specifications Laboratory Investigation Analyst training Water testing Area monitoring Environment monitoring Microbiological testing Stability studies Impurity profile Degradation studies Control samples

@Prosperity 6 Pharmaceutics

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