Product file system

1- Cover (Product name, dosage form, product code, active ingredients with strength). 2- All registration documents. (Including product composition, NODCAR file, registration agreement, etc.) 3- Preformulation report with references attached. (text books, pharmacopeia, internet search) 4- Supplier certificates of active ingredients. 5- Innovator report ( active & inactive ingredients, physical and chemical evaluation). 6- Design objective. 7- Product design strategy. 8- Experimental trials & their evaluation attached (including observation and suggestion fro next trial). 9- Final (accepted) trial with detailed formula, procedure, recommendation of any material or supplier, specifications or Q.C no. of raw materials used. 10- Copy of master formula. 11- Notes on any steps or materials needed to be changed in 1st three production batches.