Use SUPAC-MR on FDA website for a guidence.

Case Study : You work for "Best Pharma, Inc." in the CMC Regulatory Affairs Dept. You are responsible for their new blockbuster product "Skinny Me", which is amodified releasedosage form. Currently the manufacturing site is in NJ but there are plans to move the product to Puerto Rico. The PR facility had a satisfactory cGMP inspection within the last two years. The batch size will increase from 175 kg to 700kg. The new manufacturing site will move from the current hand scooping to an automated transfer of excipients into the mixer. In NJ a PK v-shell blender is used and a Fette Tablet Press. In PR, a bin blender will be used and a Manesty tablet press. The drug release is controlled by the presence of a wax matrix. The manufacturing steps consist of weighing materials, mixing and compression. No coating step is involved. Amitriptyline HCL (active ingredient) is a non-therapeutic index drug. The product has been on the market for 4 years.

• What is your proposed submission type?
• What data/documentation would you need to support this change?
• What sections in CTD would need to be updated?