If any product is introduced in plant ,should we go through Change Control or is there any another procedure.
Staff, Machinary, Utilities and Quality staff must be fit for the purpose.
The plant will get various documents and procedures from R&D.
The introduction of new product is based on Capacity and Suitability of that particular plant to that particular product.
Various validation studies will be done by the R&D and first 3 batches will be supervised.
After satisfactory results, R&D will hand over that to the production Department with all the necessary Inprocess controls enabled to the QA and QC teams.
This process is slow and steady.