Ktl-icon-tai-lieu

Thẩm định quy trình sản xuât

Được đăng lên bởi Uno Dung
Số trang: 39 trang   |   Lượt xem: 430 lần   |   Lượt tải: 0 lần
ASEAN GUIDELINE ON SUBMISSION OF MANUFACTURING
PROCESS VALIDATION DATA FOR DRUG REGISTRATION

TABLE OF CONTENTS
1.

INTRODUCTION .......................................................................................................................... 2

2.

SCOPE ........................................................................................................................................ 2

3.

DATA SUBMISSION REQUIREMENTS ...................................................................................... 2

4.

CONTENT OF DEVELOPMENT PHARMACEUTICS ................................................................. .3

5.

CONTENT OF VALIDATION SCHEME ....................................................................................... 3

6.

CONTENT OF VALIDATION REPORT........................................................................................ 4

7.

NOTES ON RETROSPECTIVE VALIDATION & CONCURRENT VALIDATION ......................... 4

8.

CHANGE CONTROL ................................................................................................................... 5

9.

TABLE OF CONTENTS OF PROCESS VALIDATION DOCUMENTATION ................................ 5

10. QUALITY BY DESIGN AS AN ALTERNATIVE APPROACH TO PROCESS VALIDATION ....... 5
11. GLOSSARY ................................................................................................................................. 5
12. DOCUMENT VERSION HISTORY ............................................................................................... 5

ANNEX A1
GUIDANCE ON PROCESS VALIDATION SCHEME FOR SOLID ORAL DOSAGE PRODUCTS
ANNEX A2
GUIDANCE ON PROCESS VALIDATION SCHEME FOR ASEPTICALLY PROCESSED PRODUCTS
ANNEX A3
GUIDANCE ON PROCESS VALIDATION SCHEME FOR TERMINALLY STERILISED PRODUCTS
ANNEX B
TABLE OF CONTENTS OF PROCESS VALIDATION DOCUMENTATION
ANNEX C
GUIDANCE FOR QUALITY BY DESIGN AS AN ALTERNATIVE APPROACH TO PROCESS
VALIDATION
ANNEX D
GLOSSARY

1

GUIDELINE ON SUBMISSION OF MANUFACTURING PROCESS VALIDATION DATA
FOR DRUG REGISTRATION

1.

INTRODUCTION

Process Validation is a means of ensuring that manufacturing processes are capable of consistently
producing a finished product of the required quality. It involves providing documentary evidence that
key steps in the manufacturing process are consistent and reproducible. A validated manufacturing
process is one that has been proven to do what it purports or is presented to do.
The term `validation’ is intended ...
ASEAN GUIDELINE ON SUBMISSION OF MANUFACTURING
PROCESS VALIDATION DATA FOR DRUG REGISTRATION
Thẩm định quy trình sản xuât - Trang 2
Để xem tài liệu đầy đủ. Xin vui lòng
Thẩm định quy trình sản xuât - Người đăng: Uno Dung
5 Tài liệu rất hay! Được đăng lên bởi - 1 giờ trước Đúng là cái mình đang tìm. Rất hay và bổ ích. Cảm ơn bạn!
39 Vietnamese
Thẩm định quy trình sản xuât 9 10 248