Wockhardt, Ltd. USFDA warning Letter
12/23/16
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LATEST UPDATE
- Technology transfer
- Correction of Documentation Errors
- New Product Design and Development Process
- Approval of vendors (Packing Materials)
- Vendor Development and Approval (API and excipients)
- Cleaning validation
- Process Validation Guidances: FDA and Global
- New EU Requirements for Qualification & Validation
- Concept of URS,Design Qualification,Installation Qualification,Operational Qualification,Performance Qualification
- Good storage practices for pharmaceuticals as per regulatory Guideline
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