©2016 lachman consultant services, inc. all rights reserved. · 2016. 5. 16. · 165 testing and...

©2016 Lachman Consultant Services, Inc. All rights reserved.

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Part 211 Section Subject Number of Letters

42 Design and construction features 28

113 Control of microbiological contamination

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28 Personnel responsibilities 17

167 Sterility testing 14

192 Production record review 11

166 Stability testing 9

165 Testing and release 5

94 Drug product containers and closures

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68 Automatic, mechanical, and electronic equipment

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100 Written procedures 3

194 Laboratory records 3

Eglovitch, J., “FY 2015 Drug GMP Warning Letters Hit Compounders and Foreign Sites”, Gold Sheet, January 29, 2016.

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Number of inspections conducted by FDA/OAI Results

Country Inspections OAI Results

USA 753 3

India 530 38

China 382 22

Germany 280 7

Canada 228 11

Italy 219 7

Japan 178 7

Cox, B., “Despite Globalization, Three Quarters of Serious Issues FDA Found Were in US”, Gold Sheet, February 25, 2016.

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Eglovitch, J., “FY 2015 Drug GMP Warning Letters Hit Compounders and Foreign Sites”, Gold Sheet, January 29, 2016.

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•Cox, B., “Trending Up: FDAs Drug GMP Data Integrity Warning Letters”, Gold Sheet, October 27, 2015;

“Data Integrity Issues Cited in All Eight FDA Warning Letters to API Makers in FY15”, Drug Industry Daily, October 9, 2015.

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http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm462075.htm; http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm474013.htm.

15

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http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm473604.htm

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http://www.accessdata.fda.gov/cms_ia/importalert_521.html; 20

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MacRae, N., “US Lawmakers Hit FDA Over ‘Inadequate’ Scrutiny of Indian, Chinese Sites”, Pharmasia News, January 5, 2016; https://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/114/Letters/20151218GAO.pdf.

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“GMP Inspections Total 350 in 6 Months, EMA Report Shows”, Drug Industry Daily, October 7, 2015; ECA Academy, “Has GMP Inspection Report of Slovenian GMP Inspectors Caused FDA and Health Canada Import Alerts?”, October 7, 2015, http://www.gmp-compliance.org/enews_05036_Has-GMP-Inspection-Report-of-Slovenian-GMP-Inspectors-caused-FDA-and-Health-Canada-Import-Alerts.html.

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http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm418347.htm.

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http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm418347.htm.

http://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/ucm350944.htm.

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Moore, C., “Introduction to Office of Process and Facilities (OPF)”, 2015 GPhA CMC Workshop, June 9, 2015.

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Moore, C., “Introduction to Office of Process and Facilities (OPF)”, 2015 GPhA CMC Workshop, June 9, 2015.

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Moore, C., “Introduction to Office of Process and Facilities (OPF)”, 2015 GPhA CMC Workshop, June 9, 2015.

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Moore C, “Introduction to Office of Process and Facilities (OPF)”, from 2015 GPhA CMC Workshop, June 9, 2015.

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