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RISK IDENTIFICATION,ASSESSMENT & MITIGATION …
Perfect Pharmaceutical Consultants Pvt. Ltd. RISK IDENTIFICATION,ASSESSMENT & MITIGATION . template . Mr. Gupta (M. Pharm.), is a free lancer consultant for US DMF, COS, ANDA, ACTD, CTD, eCTD and other regulatory submissions. He is associated with Perfect Pharmaceutical Consultants Pvt. Limited and Global Institute of Regulatory affairs (Pune, India). Abstract: The risk involved in pharmaceutical manufacturing is largely associated with: 1. Poorly written SOP, incomplete knowledge of the process/machines/materials /areas/services 2. Unauthorized changes in process, incomplete vendor audits, changes in source of raw materials 3. Incomplelete specifications of Raw materials/Finished Goods, 4. unwarranted procedures 5. Unknown personnel disabilities 6. Improper training, system failures, 7. Lack of validation activities, Lack of organizational harmony 8. Job dissatisfaction, poor maintenance, interference of the management with critical functions such as quality assurance, quality control, purchase and production, 9.
Perfect Pharmaceutical Consultants Pvt. Ltd. ©Copyright Perfect Pharmaceutical Consultants Pvt. Limited RISK IDENTIFICATION,ASSESSMENT & MITIGATION TEMPLATE . Mr. R ...
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