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US FDA CGMP

US FDA guidelines

EU GMP guides

EMA Q-guidelines

ICH API GMP

ICH Q/M(CTD)

WHO GMP

CGMP Q&A

Industry Issues: Contamination Control Strategy, Data Integrity, QbD

e-newsletter

 

 

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GMP Data Integrity Definitions and Guidance for Industry (withdrawn)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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