MODULE 2.3 QUALITY OVERALL SUMMARY: PRODUCT DOSSIER (QOS-PD) See sections 1.5, 3 and 4 of “Guideline on submission of documentation for a multisource (generic) finished pharmaceutical product (FPP): quality part” for general and detailed instructions on the completion of this template. INTRODUCTION Summary of product information: Non-proprietary name(s) of the finished pharmaceutical product(s) (FPP) Proprietary name(s) of the finished pharmaceutical product(s) (FPP) International non-proprietary name(s) of the active pharmaceutical ingredient(s) (API(s)), including form (salt, hydrate, polymorph) Applicant name and address Dosage form Reference Number(s) Strength(s) Route of administration Proposed indication(s) Primary Contact person responsible for this application Title: First name: Family Name: Contact person's job title Contact person's postal address Unit Building/PO Box number Road/Street Plant/Zone Village/suburb Town/City District and Mandal Province/State
Step/materials Test(s)/method(s) Acceptance criteria 2.3.S.2.5 Process Validation and/or Evaluation (name, manufacturer) Description of process validation and/or evaluation studies (e.g. for aseptic processing and sterilization): 2.3.S.2.6 Manufacturing Process Development (name, manufacturer) Description and discussion of the significant changes made to the manufacturing process and/or manufacturing site of the API used in producing comparative bioavailability or biowaiver, stability, scale-up, pilot and, if available, production scale batches: 2.3.S.3 Characterisation (name, manufacturer) 2.3.S.3.1 Elucidation of Structure and other Characteristics (name, manufacturer) List of studies performed (e.g. IR, UV, NMR, MS, elemental analysis) and conclusion from the studies (e.g. whether results support the proposed structure): Discussion on the potential for isomerism and identification of stereochemistry (e.g. geometric isomerism, number of chiral centres and configurations) of the API batch(es) used in comparative bioavailability or biowaiver studies: Summary of studies performed to identify potential polymorphic forms (including solvates): <including identification of and data on the API lot used in bioavailability studies> Summary of studies performed to identify the particle size distribution of the API: <including identification of and data on the API lot used in bioavailability studies> Other characteristics: 2.3.S.3.2 Impurities (name, manufacturer) Identification of potential and actual impurities arising from the synthesis, manufacture and/or degradation:
and a brief summary of the specifications): Packaging component Materials of construction Specifications (list parameters e.g. identification (IR)) (b) Other information on the container closure system(s) (e.g. suitability studies): 2.3.S.7 Stability (name, manufacturer) 2.3.S.7.1 Stability Summary and Conclusions (name, manufacturer) Summary of stress testing (e.g. heat, humidity, oxidation, photolysis, acid/base): and results: Stress condition Treatment Results (e.g. including discussion whether mass balance and peak purity are observed) Heat Humidity Oxidation Photolysis Acid Base Other Summary of accelerated and long-term testing parameters (e.g. studies conducted): Storage condition (◦C, % RH) Batch number Batch size Container closure system Completed (and proposed) testing intervals Summary of the stability results observed for the above accelerated and long-term studies:
2.3.R REGIONAL INFORMATION 2.3.R.1 Production Documentation 2.3.R.1.1 Executed Production Documents (a) List of batches (including strengths) for which executed production documents have been provided (e.g. comparative bioavailability or biowaiver batches): 2.3.R.1.2 Master Production Documents (a) The blank master production documents for each strength, proposed commercial batch size and manufacturing facility should be provided in Module 3. Discussion of differences between the proposed commercial batch size master production documents compared to the biostudy batch records with respect to the formulation (2.3.P.2.2.1 b) (ii)) and the manufacturing process (2.3.P.2.3 b)): <include a tabulated discussion for all differences, including processes, equipment (model/make/capacity), settings and operating parameters > Parameter (e.g. process, equipment, process parameter) Bioequivalence/biowaiver batch <indicate batch number> Proposed production batches <indicate proposed batch size> Discussion of the relevance of the differences <Main processes and associated equipment (make, model, capacity, settings)>