E-Library - Information At Your Fingertips: Printer Friendly 25 of 48 b) c) d) e) f) g) h) http://elibrary.judiciary.gov.ph/thebookshelf/showdocsfriendly/1/63027 odour, distinguishing features, etc.) Identification of the active ingredient(s) (must include the specific identity test for the active moiety) Quantitative determination of active ingredient(s) (i.e. Assay) Test of impurities The appropriate tests concerning the pharmaceutical properties of the dosage form (e.g. pH, content uniformity, dissolution rate, disintegration, etc) Tests for safety, sterility, pyrogens, histamine, abnormal toxicity, etc. where applicable. Technical properties of containers For drug preparations which are subject of an official monograph, the technical/quality specifications of the finished product as stated in the monograph shall be complied with. 10. Certificate of Analysis of the Finished Product 11. Pull description of the methods used, the facilities and controls in the manufacture, processing and packaging of the finished product. 12. Details of the assay and other test procedures of finished product including data analysis 13. Detailed report of stability studies to justify claimed shelf-life 14. Labeling materials 15. Representative sample 16. For imported products: Duly authenticated Certificate of Free Sale from the country of origin, and Duly authenticated government certificate attesting to the registration status of the manufacturer.[11] New drugs,[12] on the other hand, require a longer review process before the issuance of a Certificate of Product Registration. The Center for Drug Regulation and Research must first review the following requirements and conduct a series of scientific tests before the issuance of a certification: 1. All requirements for Established Drugs as stated above 2. Certificate of the Medical Director 3. Reference Standard and its corresponding Certificate of Analysis 4. Pre-clinical Data 4/21/2020, 9:19 AM