Table of Contents1.0 Purpose ......

Table of Contents
1.0 Purpose ......................................................................................................................................................... 3
2.0 Background................................................................................................................................................... 3
3.0 Scope............................................................................................................................................................. 3
4.0 Guide............................................................................................................................................................. 4
4.1 Assignment of the Risk to an Observation ....................................................................................... 4
4.2 Assignment of the Inspection Rating................................................................................................ 4
4.3 Additional Guidance ......................................................................................................................... 5
Appendix A......................................................................................................................................................... 6
Premises C.02.004 .................................................................................................................................. 6
Equipment C.02.005 ............................................................................................................................... 6
Personnel C.02.006 ................................................................................................................................. 7
Sanitation C.02.007 – C.02.008.............................................................................................................. 8
Raw Material Testing C.02.009 – C.02.010 ........................................................................................... 8
Manufacturing Control C.02.011 – C.02.012 ......................................................................................... 9
Quality Control Department C.02.013 – C.02.015 ............................................................................... 10
Packaging Material Testing C.02.016 – C.02.017 ................................................................................ 11
Finished Product Testing C.02.018 – C.02.019.................................................................................... 11
Records C.02.020 – C.02.024 ............................................................................................................... 12
Samples C.02.025 – C.02.026............................................................................................................... 12
Stability C.02.027 – C.02.028............................................................................................................... 13
Sterile Products C.02.029 ..................................................................................................................... 13
Appendix B....................................................................................................................................................... 15
Glossary of Terms................................................................................................................................. 15

Results (Vietnamese) 1:

Bảng nội dung1.0 Purpose ......................................................................................................................................................... 32.0 Background................................................................................................................................................... 33.0 Scope............................................................................................................................................................. 34.0 Guide............................................................................................................................................................. 44.1 các phân công của rủi ro để quan sát một... 44.2 các phân công của đánh giá kiểm tra... 44.3 Additional Guidance ......................................................................................................................... 5Appendix A......................................................................................................................................................... 6Premises C.02.004 .................................................................................................................................. 6Equipment C.02.005 ............................................................................................................................... 6Personnel C.02.006 ................................................................................................................................. 7Sanitation C.02.007 – C.02.008.............................................................................................................. 8Nguyên liệu thử nghiệm C.02.009-C.02.010... 8Sản xuất kiểm soát C.02.011-C.02.012... 9Chất lượng kiểm soát vùng C.02.013-C.02.015... 10Đóng gói vật liệu thử nghiệm C.02.016-C.02.017... 11Sản phẩm hoàn tất thử nghiệm C.02.018-C.02.019... 11Records C.02.020 – C.02.024 ............................................................................................................... 12Samples C.02.025 – C.02.026............................................................................................................... 12Stability C.02.027 – C.02.028............................................................................................................... 13Sterile Products C.02.029 ..................................................................................................................... 13Appendix B....................................................................................................................................................... 15Glossary of Terms................................................................................................................................. 15

Results (Vietnamese) 2:

Mục lục
1.0 Mục đích 3
2.0 3
3.0 3
4.0 4
4.1 Phân rủi ro đến một quan sát ......................................... .............................................. 4
4.2 Phân công Thanh tra 4
4.3 Hướng dẫn khác 5
Phụ lục 6
Premises C.02.004 6
Thiết bị C.02.005 6
cán C.02.006 7
Vệ sinh C.02.007 - 8
Raw Material Testing C.02.009 - C.02.010 ....................................... .................................................. .. 8
Sản xuất Kiểm soát C.02.011 - C.02.012 ...................................... .................................................. . 9
Cục Quản lý Chất lượng C.02.013 - C.02.015 ...................................... ......................................... 10
Packaging Material Testing C.02.016 - C .02.017 ................................................ ................................ 11
Hoàn tất sản phẩm Testing C.02.018 - C.02.019 ....... .................................................. ........................... 11
ghi C.02.020 - C.02.024 12
mẫu C.02.025 - 12
Tính ổn định C.02.027 - 13
Sterile Sản phẩm C.02.029 13
Phụ lục 15
Thuật ngữ của 15