Guidance for Industry GMP 가이드

본래의 목적으로 운영하려던 GMP제약에 대한 포스팅이 적어 오늘은 오랜만에 가이던스를 읽던 중 좋은 정보가 있어 공유하고자 합니다.

 

Contract Manufacturing Arrangements for drugs 이며 2013년 5월 개정된 가이드입니다.

 

 

개요는 아래와 같이 있습니다!

 

I. Introduction............................................................................................................................1
II. Defining the “Who” and “What” of Contract Manufacturing...........................................2
III. Establishing Responsibilities of Contract Manufacturing.................................................2
A. Statutory and Regulatory Framework................................................................................2
B. Contract Manufacturing and Quality Management: Existing Guidance...........................3
IV. Documenting Contract manufacturing arrangements in Quality Agreements...............4
A. What is a Quality Agreement?............................................................................................4
B. Elements of a Quality Agreement.......................................................................................5
1. Responsibilities..................................................................................................................6
a) Quality Unit Responsibilities..........................................................................................6
b) Facilities and Equipment................................................................................................7
c) Materials Management...................................................................................................7
d) Product-Specific Terms..................................................................................................7
e) Laboratory Controls........................................................................................................8
f) Documentation................................................................................................................8
2. Change Control, Including Subcontractors.........................................................................8
V. Illustrative Scenarios..............................................................................................................9
A. A Quality Agreement Does Not Exempt Contracted Facilities from CGMP Requirements Related to the Operations they Perform, Regardless of Whether such CGMP Requirements are Specifically Discussed in the Quality Agreement.......................................................................9
1. Case 1: Responsibility for Facilities and Equipment Maintenance and Upkeep at Contracted Facility..................................................................................................................9
2. Case 2: Responsibility for Documenting Steps in the Manufacturing Process............10
B. Contract Laboratories are Contracted Facilities Subject to CGMP Requirements:.......11
1. Case 3: Responsibility for Data Integrity in Laboratory Records and Test Results.....11
2. Case 4: Responsibilities for Method Validation...........................................................11
VI. Conclusion...........................................................................................................................11

 

필요하신 분은 댓글 남겨주시면 공유하겠습니다^^ 특히 Facility쪽은 한번 읽어보기 좋은 내용이 많이 있습니다.

 

즐거운 하루 되세요.