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: Contamination Control Strategy, Data Integrity, QbD

e-newsletter

Korean GMP

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

Post-Authorisation (Lifecycle Management)

1.

EU variations guidelines - Guidelines on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products

번역문 New

Active Substance

1.

Guideline on the Chemistry of New Active Substances

2.

Guideline on Summary of Requirements for Active Substances in the Quality Part of the Dossier

3.

Reflection paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances

4.

Quality Working Party questions and answers on API mix

Manufacture of the medicinal products

1.

Guideline on Process Validation for Finished Products - information and data to be provided in regulatory submissions

2.

Guideline on Manufacture of the Finished Dosage Form

3.

Annex: Start of Shelf-Life of the Finished Dosage Form

4.

Guideline on the Sterilisation of the Medicinal Product, Active Substance, Excipient and Primary Container

Specifications, analytical procedures and analytical validation

1.

Guideline on Real Time Release Testing (formerly Guideline on Parametric Release)

2.

Use of Near Infrared Spectroscopy (NIRS) by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations

Excipients

1.

Quality of Water for Pharmaceutical Use

2.

Questions and Answers on Production of Water for Injections by Non-distillation Methods - Reverse Osmosis and Biofilms and Control Strategies

3.

Guideline on Excipients in the Dossier for Application for Marketing Authorization of a Medicinal Product

Packaging

1.

Plastic Primary Packaging Materials

Stability

1.

In-Use Stability Testing of Human Medicinal Products

2.

Maximum Shelf-Life for Sterile Products for Human Use After First Opening or Following Reconstitution

3.

Guideline on Stability Testing for Applications for Variations to a Marketing Authorisation

Biologicals

1.

Development, Production, Characterisation and Specifications for Monoclonal Antibodies and Related Products

2.

Process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission

Multidisciplinary: cell therapy and tissue engineering

1.

Questions and answers on comparability considerations for advanced therapy medicinal products (ATMP) New