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change notification for the manufacturing methods

Application for GMP Inspection to Obtain Marketing Approval or Approval for Partial Changes in Approved Information, or to Manufacture Drugs for Export etc. (1) When an applicant applies for a GMP inspection to obtain marketing approval or approval to make partial changes to the approved information (hereinafter referred to as “partial change approval”) for a drug (excluding drugs that are drug substances), quasi-drug, or medical device (hereinafter referred to as “drugs etc.”), or to manufacture drugs for export etc., the applicant shall, in principle, submit an application for a GMP inspection for each relevant product. As a rule, the application for a GMP inspection must be submitted to an inspection entity that will conduct the GMP inspection (hereinafter referred to as “competent inspection authority”) for all manufacturing sites and other relevant sites indicated in the product approval application (including manufacturing sites of drug substances, manufacturing sites for packaging, external testing laboratories, and organizations that perform design and development control

[hereinafter referred to as “design and development control”]

; the same shall apply hereinafter). (2) When an applicant applies for GMP inspections for multiple products that are manufactured using the same drug substance (refers to that manufactured at the same manufacturing site, by the same manufacturing method, manufacturing process, or manufacturing facility, or according to the same specification, etc.; the same shall apply hereinafter), a single application for a GMP inspection may cover all the multiple products, provided that the GMP inspection is performed only for the manufacturing site of the drug substance. In this case, make a note on the application form to the effect that the application is made for an inspection in relation to multiple products, and list all the applicable products. The inspection fee for multiple products is the same as that for a single product.