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1. Current Good Manufacturing Practice for Finished Pharmaceutical Products 21 CFR 211.63 2. Current Good Manufacturing Practice for Finished Pharmaceutical Products 21 CFR 211.68 3. Good Laboratory Practice for Non-Clinical Studies, 21 CFR 58.61 and 58.63 4. Principles of Good Laboratory Practice, Organisation of Economic Cooperation and Development (OECD), Section 4. Apparatus, Material, and Reagents clauses 1 and 2 5. Good Laboratory Practice, Ordinance 21, Ministry of Health Labour and Welfare Chapter 3 Testing Facilities and Equipment (Equipment), Article 10 6. EU Good Manufacturing Practice regulations, Chapter 3 Facilities and Equipment, clauses 3.40 and 3.41 7. Current Good Manufacturing Practice for Finished Pharmaceutical Products 21 CFR 211.160(b) 8. Current Good Manufacturing Practice for Finished Pharmaceutical Products 21 CFR 211.160(b)(4) 9. Current Good Manufacturing Practice for Finished Pharmaceutical Products 21 CFR 211.194(a) 10. Current Good Manufacturing Practice for Finished Pharmaceutical Products 21 CFR 211.194(c) 11. Current Good Manufacturing Practice for Finished Pharmaceutical Products 21 CFR 211.182 12. EU Good Manufacturing Practice regulations, Chapter 4, clause 4.31 13. United States Pharmacopoeia <41> Weights and Balances, Rockville, Maryland, 2013 14. United States Pharmacopoeia <1251> Weighing on an Analytical Balance, Rockville, Maryland, 2013 15. United States Pharmacopoeia <1058> Analytical Instrument Qualification, Rockville, Maryland, 2013 16. Able Laboratories, FDA Form 483 Observations, July 2005 17. Compliance Program Guide 7346.832 Pre-Approval Inspections published May 2010, effective May 2012. 18. FDA Post 483 Inspection Program August 2009 19. GMP (Good Weighing Practice) The Standard, Science Based Weighing, 20. FDA Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance Laboratory Controls http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/ Guidances/ucm124785.htm#1 (accessed 18 Aug 2013) TEL : 03-5815-5515 FAX: 03-5815-5525 TEL : 06-6266-1187 FAX: 06-6266-1379 Email : sales.admin.jp@mt.com www.mt.com 110-0008 2-9-7 6 541-0053 2-1-6 15 F 09/2013 Mettler-Toledo AG Printed in Switzerland 30101193