Annexure 4

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1. Annexure III (Product Detail)
2. Annexure 2
3. Annexure-III Rating Criteria
4. Annexure-XIII Cleaning Details after Methanol Rinse
5. Annexure-5 Calculation of Contamination Limit
6. RISK ASSESSMENT ANNEXURE-1 (BEFORE QUALIFICATION)
7. RISK ASSESSMENT ANNEXURE-2 (AFTER QUALIFICATION) OF QC DOCUMENTATION
8. RISK ASSESSMENT ANNEXURE-1 (BEFORE QUALIFICATION)
9. Annexure I (Area Clearance in Solid Dosage Manufacturing – Batch to Batch Changeover)
10. Annexure-XIII Cleaning Details after Methanol Rinse