Overview on ASEAN Guideline on PV Requirements

the 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 …

  Dossiers, Asean

GUIDELINE FOR STABILITY DATA

(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

  Preservation, Antimicrobial, Efficacy, Efficacy of antimicrobial preservation

DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD)

PREAMBLE 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 ...

  Notes, Preamble, Explanatory notes, Explanatory

MINISTRY OF HEALTH MALAYSIA MICROBIAL …

90ml 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)

  Solutions, Peptone, Peptone solution

Guidelines for Control of Cosmetic Products in Malaysia

GUIDELINES 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

  Guidelines, Product, Control, Cosmetic, Malaysia, Guidelines for control of cosmetic products in malaysia

BACTERIAL ENDOTOXIN TEST

NPCB 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

•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

  Pharmaceutical, Validation, Cleaning, Halal, Halal pharmaceuticals

General Guidelines on Good Manufacturing Practices

1.3 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.

  Guidelines, Good, Practices, Manufacturing, Good manufacturing, Guidelines on good manufacturing practices

APPENDIX 8: LIST OF PERMITTED, PROHIBITED AND …

32. 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.

  Menthol

General Food Labelling Requirements

GENERAL FOOD LABELLING REQUIREMENTS fi ABU DHABI AGRICULTURE AND FOOD SAFETY AUTHORITY)3(4.4 Infant foods based on milk 39 4.5 Irradiated foods40 4.6 Organic foods40 4.7 Sweeteners permitted for use in food products …

  Requirements, Labelling, Labelling requirements

Environmental labelling and information schemes

requirements such as Forest Stewardship Council or Fair Trade). The landscape of organisations involved in the labelling world is complex and extends beyond just suppliers and users, with a variety of private and public institutions directly or indirectly involved in many aspects of their development and operation (Box 2), for example:

  Requirements, Labelling

BS EN ISO 15223-1 Medical devices -- Symbols to be used ...

BS EN ISO 15223-1 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied. Part 1: General requirements

  Requirements, Labelling