Quality Control


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:


Quality Assurance Department

Quality Control Department

cGMP implementation
Self inspection
Market complaints
Vendor evaluation
Document review
Process non-conformity review and approval
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
Approval/rejection as per the test status.
Method validation
Laboratory Investigation
Analyst training
Water testing
Area monitoring
Environment monitoring
Microbiological testing
Stability studies
Impurity profile
Degradation studies
Control samples


@Prosperity 6 Pharmaceutics Developed by Gravity Technologies