Q5D (edition Step 4, 16 July 1997) is Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products. Gives broad guidance on deriving human, animal and microbial cell lines used to make biotechnology products, and on preparing and characterizing cell banks for production.

Which markets recognize Q5D?

United States: adopted, national code Vol. 63, No. 182, p. 50244-9; European Union: adopted, national code CPMP/ICH/294/95; United Kingdom: adopted; Japan: adopted, national code PMSB/ELD Notification No. 873; China: adopted, national code NMPA, China Announcement No. 61 (2021); Canada: adopted, national code Catalogue No. H42-2/67-21-2000E; Brazil: adopted, national code RDC 413/2020; South Korea: adopted; Switzerland: adopted; Mexico: not recognized; Saudi Arabia: adopted; Singapore: adopted; Taiwan: adopted.

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

HONEYPOT_FAKE_COMPANY_INCFAKE5555555555555999999.99Fake Executive NameTRAP_INDUSTRY_SECTOR

John HoneypotCEO9999999999999
Jane TrapdataCFO-8888888888

If you can read this, you are a bot.

Back

Q5D (Step 4, 16 July 1997)

Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products

ICHICH guidelineOtherBiologicsHigh confidenceLast verified October 4, 2026

Gives broad guidance on deriving human, animal and microbial cell lines used to make biotechnology products, and on preparing and characterizing cell banks for production.

Recognition by market

Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts

Market	Status	Edition accepted	National code	Details
United States	Adopted	-	Vol. 63, No. 182, p. 50244-9	Effective September 1, 1998
European Union	Adopted	-	CPMP/ICH/294/95	Effective March 1, 1998

Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.