Q7a
锛?/p>
涓嫳鏂囧鐓?/p>
锛?/p>
FDA
鍘熸枡鑽?/p>
GMP
鎸囧崡
Table of Contents
鐩綍
1. INTRODUCTION
1.
绠�浠?/p>
1.1 Objective
1.1
鐩殑
1.2 Regulatory Applicability
1.2
娉曡鐨勯�傜敤鎬?/p>
1.3 Scope
1.3
鑼冨洿
2. QUALITY MANAGEMENT
2.
璐ㄩ噺绠＄悊
2.1 Principles
2.1
鎬诲垯
2.2 Responsibilities of the Quality Unit(s)
2.2
璐ㄩ噺閮ㄩ棬鐨勮矗浠?/p>
2.3 Responsibility for Production Activities
2.3
鐢熶骇浣滀笟鐨勮亴璐?/p>
2.4 Internal Audits (Self Inspection)
2.4
鍐呴儴瀹¤锛堣嚜妫�锛?/p>
2.5 Product Quality Review
2.5
浜у搧璐ㄩ噺瀹℃牳
3. PERSONNEL
3.
浜哄憳
3.1 Personnel Qualifications
3.
浜哄憳鐨勮祫璐?/p>
3.2 Personnel Hygiene
3.2
浜哄憳鍗敓
3.3 Consultants
3.3
椤鹃棶
4. BUILDINGS AND FACILITIES
4.
寤虹瓚鍜岃鏂?/p>
4.1 Design and Construction
4.1
璁捐鍜岀粨鏋?/p>
4.2 Utilities
4.2
鍏敤璁炬柦
4.3 Water
4.3
姘?/p>
4.4 Containment
4.4
闄愬埗
4.5 Lighting
4.5
鐓ф槑
4.6 Sewage and Refuse
4.6
鎺掓薄鍜屽瀮鍦?/p>
4.7 Sanitation and Maintenance
4.7
鍗敓鍜屼繚鍏?/p>
5. PROCESS EQUIPMENT
5.
宸ヨ壓璁惧
5.1 Design and Construction
5.1
璁捐鍜岀粨鏋?/p>
5.2 Equipment Maintenance and Cleaning
5.2
璁惧淇濆吇鍜屾竻娲?/p>
5.3 Calibration
5.3
鏍￠獙
5.4 Computerized Systems
5.4
璁＄畻鏈烘帶鍒剁郴缁?/p>
6. DOCUMENTATION AND RECORDS
6.
鏂囦欢鍜岃褰?/p>
6.1 Documentation System and Specifications
6.1
鏂囦欢绯荤粺鍜岃川閲忔爣鍑?/p>
6.2 Equipment cleaning and Use Record
6.2
璁惧鐨勬竻娲佸拰浣跨敤璁板綍
6.3 Records of Raw Materials, Intermediates, API
Labeling and Packaging Materials
6.3
鍘熸枡銆?/p>
涓棿浣撱�?/p>
鍘熸枡鑽殑鏍囩鍜屽寘瑁呮潗鏂欑殑
璁板綍
6.4
Master
Production
Instructions
(Master
Production and Control Records)
6.4
鐢熶骇宸ヨ壓瑙勭▼锛堜富鐢熶骇鍜屾帶鍒惰褰曪級
6.5
Batch
Production
Records
(Batch
Production
and Control Records)
6.5
鎵圭敓浜ц褰曪紙鎵圭敓浜у拰鎺у埗璁板綍锛?/p>