APPENDIX 9: LABELLING REQUIREMENTS
APPENDIX 9: LABELLING REQUIREMENTS This appendix comprises of two (2) parts: ... Only a single label artwork is permitted for all pack sizes of a registered product. f) No stick-on label is permitted. Any usage of stick-on label shall have prior approval by the Authority. The Authority will only consider the following situations:
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GUIDELINE FOR STABILITY DATA
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www.npra.gov.mythe effect that the same pre-approval dossier pertaining to process validation that have been submitted to the reference regulatory agency are submitted to DRA for evaluation. Under certain circumstances where validation documents may ... The …
BACTERIAL ENDOTOXIN TEST
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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
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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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