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GMP 교육 / 컨설팅 / GMP 문서 번역

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: Data Integrity, QbD

e-newsletter

 

 

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

 

 


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GMP Data Integrity Definitions and Guidance for Industry (withdrawn)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 (2019 3)

 


 

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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