Does the manufacturer include in Section 2.3.R copies of executed 17 biobatch and proposed blank master production record(s) for proposed production batch(es) Comment 18 Is there data presented on validation of analytical procedures Comment Is there data on FPP batch sizes and composition of pilot and 19 production scale as well as those used in bioequivalence and dissolution studies (e.g. 2.3.P.2.2.1) Comment Does the applicant indicate the full physical address of the FPP manufacturing site including Unit and Block numbers, where 20 applicable Comment Additional requirements for Sterile FPP are met? (see Part C) 21 Comment * or for uncomplicated FPPs (see quality guideline), at minimum one pilot batch and one can be smaller as per the quality guideline (). For 2nd-line TB and for RH products, 3 months accelerated + 3 months long term is required at the time of screening. Comments on deficiencies with reference to table above and specific dossier sections Additional data requested (to be communicated to the applicant) C – If sterile API is purchased Manufacturing process validation data including media fill results from a recent media fill exercise/study for the aseptic process at the API manufacturing site is submitted? Suitability of container closure compatibility with API, demonstration of seal — integrity (e.g. by microbial ingress test, dye ingress test), suitability for transportation to FPP site etc. Provided? Rubber stoppers/gasket: Supplier name, type and stopper number; evidence of
17 Does the manufacturer include in Section 2.3.R copies of executed biobatch and proposed blank master production record(s) for proposed production batch(es) Comment 18 Is there data presented on validation of analytical procedures Comment 19 Is there data on FPP batch sizes and composition of pilot and production scale as well as those used in bioequivalence and dissolution studies (e.g. 2.3.P.2.2.1) Comment 20 Does the applicant indicate the full physical address of the FPP manufacturing site including Unit and Block numbers, where applicable Comment 21 Additional requirements for Sterile FPP are met? (see Part C) Comment * or for uncomplicated FPPs (see quality guideline), at minimum one pilot batch and one can be smaller as per the quality guideline (). For 2nd-line TB and for RH products, 3 months accelerated + 3 months long term is required at the time of screening. Comments on deficiencies with reference to table above and specific dossier sections Additional data requested (to be communicated to the applicant) C – If sterile API is purchased Manufacturing process validation data including media fill results from a recent media fill exercise/study for the aseptic process at the API manufacturing site is submitted? Suitability of container closure — compatibility with API, demonstration of seal integrity (e.g. by microbial ingress test, dye ingress test), suitability for transportation to FPP site etc. Provided? Rubber stoppers/gasket: Supplier name, type and stopper number; evidence of
83%20Screening%20checklist%20generic%20product_June2015_0.docx