Hello sir,
Can anybody explain the procedure to launch a new product (From trial to final) step by step?
Following aspects should be covered,
1 To raise Change control proposal
2 To write protocol on Technology transfer from R & D scale to production scale (both for production and analytical method transfer)
3 To write Master Manufacturing document
4 To frame Batch Manufacturing and packing formats
5 To finalise specifications of raw materials and packaging materials and methodof analysis
6 To finalise in process material controls
7 To finalise finished product specification and method of analysis
8 To perform and write Risk assessment document
9 To prepare draft of SOPs on Cleaning of manufacturing equipment
10 To provide training to the production, QC Laboratory and QA persons on the launch of new product.and new analytical methods.
11 To assess Regulatory impact and ensure compliance with respect to Regulatory filing etc.
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Sir,
Who will be the authorized person for these all procedure.
1 Like
Sir,
Thank you sir for your replies.
What about SOP’s?
Department wise Who will prepare and who will issue?