1. SCOPE: This protocol is applicable for the cycle development study of tunnel with applicable containers in manufacturin...
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STERILE FORMULATION- VENDOR QUALIFICATION
Vendor qualification is done for Raw material (Active Pharmaceutical Ingredients/Excipients), Packaging Material (Both primary, secondary...
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Systems and Equipment Qualification in Pharmaceuticals
1. OBJECTIVE To lay down a procedure for preparation, review, and approval of Performance Qualification (PQ) and Re-Qualification...
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Responsibilities of quality assurance department
1. OBJECTIVE To lay down a procedure on responsibilities of Quality Assurance department. 2. SCOPE This proced...
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Quality assurance terminology and Definitions
S. No. Terms Definition A 1 Acceptance Criteria Th...
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