DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD)
Regulation 2, CDCR 1984) Licensed Wholesaler: A person to whom a wholesaler's licence has been issued Regulation 12, CDCR 1984 (as defined in Regulation 2, CDCR 1984) Manufacturer: A person carrying out one or more of the steps specified in the definition of manufacture. Manufacture, in relation to any product includes –
Download DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD)
Information
Domain:
Source:
Link to this page:
Documents from same domain
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
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. …
Overview on ASEAN Guideline on PV Requirements
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
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.