H GB( 1) T - 1GUIDELINE No.:Technical Guideline for Making Post Approval Changes to Chemical DrugProducts1April 20082Table of contentsI. Overview...........................................................................................................................2II. Basic principles for performing studies post-approval changes to chemical drug products...............................................................................................................................3III. Changes to Drug Substance Manufacturing Process.....................................................6IV. Changes to excipients in a drug formulation...............................................................14V. Changes to the manufacturing process for a drug product.........................................22VI. Changes to drug product strength and packaging size..............................................30VII.Change............................................................to drug prodcugt specificication36VIII. Changes to the drug prodcut shelf-life (expiration dating period) and/or storage conditions...........................................................................................................................41IX. Changes to drug product packaging materials and the container closure syatem ... 37X. Changes to the manufacturing site of an imported drug product...............................51XI. Change to the manufacturing site of API used in an imported drug product and change to the manufacturing site of an imported API......................................................48XII. Changes in the site of Manufacture for API used in a domestic drug product..... Error! Bookmark not defined.Appendix I Basic methods for comparison investigation of drug dissolution/release.....36Appendix II General considerations f...
