DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 96
Drug Registration Guidance Document (DRGD)11. GUIDELINE FOR THE SUBMISSION OF PRODUCTSAMPLES FOR LABORATORY TESTINGThe submission of sample for laboratory testing is as part of the registration process. Thisguideline consists of the general and specific requirements for the submission of samplesto the Centre for Quality Control for laboratory testing. The general requirements define thecondition of the samples to be submitted whereas the specific requirements illustrate theadditional details needed according to the category of product.The applicant is given a period of 14 days from the date of confirmed payment to sendsamples for laboratory testing. If the samples are not submitted within the specified timeframe, the product registration application shall be tabled to the Authority for rejection.The applicants shall comply with these requirements and failure to meet any of theserequirements may cause rejection of the samples.11.1 GENERAL REQUIREMENTSa) After the registration payment has been approved, applicants must makeappointment with the Laboratory Services Unit for the submission of registrationsamples for laboratory testing.b) Requirements for samples:i) Samples submitted must be in their original packaging & labeling.ii)iii)Samples submitted must be from the same manufacturing premise as statedin the application for registration.Samples submitted must have an expiry date of least one (1) year from thedate of submission.c) For imported products, applicants are required to submit the original import permittogether with the samples for laboratory testing. The import permit will be issued bythe Centre for Registration and Centre for Quality Control for natural product andpharmaceutical products, respectively. The applicant should ensure that the importpermit is endorsed by the enforcement officer at the entry point.d) The payment voucher and approved payment application status should also besubmitted together with the samples.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 97
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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