Process Validation (PV)
• Container-closure integrity • Sorption and leaching issues f) Microbial attributes of dosage form g) Compatibility of drug product with diluents or dosage device (e.g precipitation of drug substance in solution, sorption on injection vessels etc) throughout shelf life of drug product 17
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GUIDELINE FOR STABILITY DATA
www.npra.gov.my(e.g., Efficacy of Antimicrobial Preservation of the BP or Antimicrobial Preservative Effectiveness Test of the USP) and by performing chemical assays for the preservatives during the regular stability testing schedules. If a lack of or low levels are found, testing for sterility should be carried out. iv) Dissolution testing
DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD)
www.npra.gov.myPREAMBLE This “DRUG ... *EXPLANATORY NOTES FOR REPACKERS 1. Introduction This chapter is intended to provide guidance to those engaged in repackaging of finished products with the aim to provide information to any person/ establishments who removes finished products from their original container-closure system and repackages ...
MINISTRY OF HEALTH MALAYSIA MICROBIAL …
www.npra.gov.my90ml of Buffered NaCl Peptone Solution + ≤100 cfu S. aureus Enrichment: 90ml of Tryptone Soya Broth (TSB), 30 - 35ºC, 18 – 24hrs 10 ml Selective Agar: Mannitol Salt Agar (MSA) Subculture on 30 -35ºC, 18 – 72hrs ≤100 cfu Ps. aeruginosa Cetrimide Agar (CETA)
Guidelines for Control of Cosmetic Products in Malaysia
www.npra.gov.myGUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA NATIONAL PHARMACEUTICAL REGULATORY AGENCY MINISTRY OF HEALTH, MALAYSIA 1st Revision – February 2017 Please visit the NPRA website for the latest updates
APPENDIX 9: LABELLING REQUIREMENTS
www.npra.gov.my9.1 GENERAL LABELLING REQUIREMENTS The following information in Table 1 shall present on the label of a product at outer carton, immediate container or blister/ strips: No. Parameters Outer Carton (Unit Carton) Immediate Labels Blister/ Strips 1. …
BACTERIAL ENDOTOXIN TEST
www.npra.gov.myNPCB MOH e. Test methods • Describe how the test is performed in detail • Gel clot method: European Pharmacopeia 5.0, 2.6.14 Bacterial endotoxins, Gel clot technique (Method A and B) 1. Preparatory Testing i. Confirmation of labeled lysate sensitivity
HALAL PHARMACEUTICALS
www.npra.gov.my•The pharmaceuticals are designed and develop in a way that comply with the ... Cleaning Procedures and Validations Right Formula . NPCB 46 Validation The documented act of proving that any procedure, process, equipment, material, activity, or system actually leads to the
General Guidelines on Good Manufacturing Practices
www.npra.gov.my1.3 Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Product Registration or product specification. Good Manufacturing Practice is concerned with both production and quality control.
APPENDIX 8: LIST OF PERMITTED, PROHIBITED AND …
www.npra.gov.my32. Menthol External Preparations >16% 33. Mestranol Oral Contraceptives 34. Methylene Blue Oral Preparations 35. Midazolam All oral preparations, except 7.5mg coated tablet 36. Morphine Cough Mixtures 37. Neomycin Oral Antidiarrhoeal, Vaginal Tablets, Topical Powders, Aerosols, Nasal Preparations 38. Noradrenaline Dental Preparations 39.
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