(makes, models, qualification status (IQ, OQ, PQ),
qualification status), drawings, manuals, logs, SOPs
8. Process transfer: Process validation All process detail
Manufacturing protocol and report
9. Cleaning Product and site-specific Cleaning validation details
WHO Guidelines for Transfer of Technology 85
1. Explain organisation and management in detail.
2. Describe the application of QRM in pharmaceuticals.
3. Explain the process of analytical method transfer in detail.
1. Explain the characteristics of transfer of technology as per WHO. What are the
principles to be followed for successful technology transfer?
2. Describe the scope of WHO guidelines for TOT.
4. What is quality risk management? Explain QRM process.
6. Explain various types of documents needs to be prepared during TOT as per WHO
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