©2016 lachman consultant services, inc. all rights reserved. · 2016. 5. 16. · 165 testing and...
TRANSCRIPT
©2016 Lachman Consultant Services, Inc. All rights reserved.
•
•
•
•
•
•
Part 211 Section Subject Number of Letters
42 Design and construction features 28
113 Control of microbiological contamination
27
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
5
68 Automatic, mechanical, and electronic equipment
4
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.
9
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.
10
•
•–
–
•
–
Eglovitch, J., “FY 2015 Drug GMP Warning Letters Hit Compounders and Foreign Sites”, Gold Sheet, January 29, 2016.
11
•–
–
–
•–
•–
–
–
–
•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.
14
•–
–
–
•–
–
–•
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm462075.htm; http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm474013.htm.
15
•–
–
–
–
–
–
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm473604.htm
17
•
–
•
–
http://www.accessdata.fda.gov/cms_ia/importalert_521.html; 20
•
•
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.
22
•
–
–
•
•
“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.
•
•
•
•
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm418347.htm.
•
•
•
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm418347.htm.
http://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/ucm350944.htm.
•
–
–
–
•–
–
–
–
Moore, C., “Introduction to Office of Process and Facilities (OPF)”, 2015 GPhA CMC Workshop, June 9, 2015.
•
–
–
–
Moore, C., “Introduction to Office of Process and Facilities (OPF)”, 2015 GPhA CMC Workshop, June 9, 2015.
•–
•–
•–
–
Moore, C., “Introduction to Office of Process and Facilities (OPF)”, 2015 GPhA CMC Workshop, June 9, 2015.
•
–
–
–
–
–
–
Moore C, “Introduction to Office of Process and Facilities (OPF)”, from 2015 GPhA CMC Workshop, June 9, 2015.
•–
–
–
–
–
•
•
•
•
•
•
•
–
•
•
•
•