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GMP 교육 / 컨설팅 / GMP 문서 번역

US FDA guidelines

EMA Q-guidelines

Industry Issues: Contamination Control Strategy, Data Integrity, QbD

GMP Case Study: Lessons from FDA 483s & Warning Letters

Contamination Control Strategy

ECA Task Force on Contamination Control Strategy에서 CCS 가이드라인 문서를 발행했습니다.

EU GMP Annex 1에 규정된 CCS(contamination control strategy)의 개발과 문서화를 위한 가이드라인, template, gap assessment 사례, 참고문헌으로 구성된 것입니다.

아래 링크에서 신청서를 작성해 제출하면 받아볼 수 있습니다.

How to Develop and Document a Contamination Control Strategy: ECA Task Force on Contamination Control Strategy

Data Integrity

Data Integrity 관련 참고 문헌입니다. 미국 FDA 가이드 문서만 영한 대역 번역문이고 나머지는 원문 파일입니다.

US FDA	Data Integrity and Compliance with Drug CGMP: Questions and Answers (2018 12)
UK MHRA	GXP Data Integrity Guidance and Definitions (2018 3)
	GMP Data Integrity Definitions and Guidance for Industry (withdrawn)
PIC/S	Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1, 1 July 2021)
WHO	Guideline on Data Integrity (2021)
APIC	Practical Risk-Based Guide for Managing Data Integrity

QbD(Quality by Design) Documents

QbD 가이드라인 문서

ICH Q8(R2)	Pharmaceutical Development
ICH Q9	Quality Risk Management
ICH Q10	Pharmaceutical Quality System
	ICH Q8, Q9, Q10 Questions & Answers
	ICH Quality Implementation Working Group Points to Consider (R2): ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation
ICH Q11	Development and Manufacture of Drug Substances

US FDA	PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
US FDA	Quality Systems Approach to Pharmaceutical CGMP Regulations
US FDA	Process Validation: General Principles and Practices

EMA-FDA	EMA-FDA pilot program for parallel assessment of Quality-by-Design applications: lessons learnt and Q&A resulting from the first parallel assessment
EMA-FDA	Questions and Answers on Design Space Verification
EMA-FDA	Questions and Answers on Level of Detail in the Regulatory Submissions
EMA	Questions and Answers: Improving the Understanding of NORs, PARs, DSp and normal variability of process parameters New

QbD 사례 문서

EFPIA Draft Mock P2 Document for "Examplain" Hydrochloride	*번역문*
EFPIA Mock P2 Presentation
"ACE Tablets" Pharmaceutical Development Case Study	*번역문*
"Sakura Tablet" Case Study Materials (NIHS, Japan)	*번역문*
A-Mab: A Case Study in Bioprocess Development	*번역문*
Quality by Design for ANDAs: An Example for Immediate-Release Dosage Forms (April, 2012)	*번역문*
Quality by Design for ANDAs: An Example for Modified Release Dosage Forms (December 2011)	*번역문*
A-VAX: Applying Quality by Design to Vaccines	*번역문*

참고 자료

Continued Process Verification - An Industry Position Paper With Example Plan

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