DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)10.2.2 PARTIAL VALIDATION FOR COMPENDIAL/ PHARMACOPOEIALMETHODSTABLE X:CharacteristicsIdentificationType of Analytical MethodTesting for ImpuritiesQuantitationLimitAssay:- dissolution(measurement only)- content/ potencyPrecisionInterm. Precision √ (1)Specificity (2) √ √ √ √Detection Limit (3) √Quantitation Limit√Note:√signifies that this characteristic is normally evaluated.(1) In cases where reproducibility has been performed, intermediate precision is notneeded.(2) Lack of specificity of one analytical procedure could be compensated by othersupporting analytical procedure(s).(3) May be needed in some cases.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 96
Drug Registration Guidance Document (DRGD)10.3 TYPICAL VALIDATION CHARACTERISTICS FORMICROBIOLOGICAL TESTS:Table XI:Microbiological testsBacterial Endotoxin TestSterility TestMicrobial ContaminationTestMicrobiological Assay ofAntibioticsValidation characteristicsa. Test for Confirmation of Labelled LysateSensitivity(Verification of criteria for standard curve)b. Test for Interfering Factors (Inhibition/ Enhancementtests)Validation (Bacteriostasis or Fungistasis) TestQuantity of Sample/ Volume of SampleMembrane filtration/ Direct inoculationOpen System or Closed System (if uses Membranefiltration method)Volume of rinsing fluida. Validation of total viable aerobic count (suitability of thecounting method in the presence of product)b. Validation of test for specified microorganism (suitabilityof the test method)Linearity of the dose response relationshipNote:1. All the analytical validation done by the industry should be in accordance to ASEANGuidelines for Analytical Procedures, ICH Technical Requirements for Registration ofPharmaceuticals for Human Use under Validation of Analytical Procedures: Text andMethodology Q2 (R1), British Pharmacopoeia (BP) or United State Pharmacopeia(USP).2. The applicants should ensure all documents available in the online Quest system are ofthe latest versions. All correspondence on the protocol of analysis and analyticalmethod validation should comply with any relevant circulars regarding the registrationprocess. Failure to do so may cause cancellation or rejection of product registration(Reference: Circular Bil (08) dlm. BPFK/PPP/01/03)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 97
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PART III: NON-CLINICAL DATADrug Reg
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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