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| Quality Organization |
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Gyrochem quality policies are developed at a corporate level, and implemented at each of the quality units. The quality units are independent of production and report up through the overall quality organization.
QA Responsibilities
 Qualification and validation activities
Control of documents
Batch record review
Product release
Investigation of nonconformances
Risk assessment
Implementation of corrective and preventive actions
Change control and customer notifications
Training
Internal, customer and regulatory audits
Supplier qualification and audits
Regulatory review of APIs and cGMP manufactured products
Review and approval of final and raw material product specifications
Review and approval of all manufacturing and packaging documents and operating procedures
QC Responsibilities
Method development, and method validation
Writing and approving quality control procedures and protocols
Sampling and testing of raw materials and intermediates
Chemical, physical, biological, and microbiological testing of final products
Stability testing and management of ICH stability program
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