Question 1

What is Q10?

Accepted Answer

Q10 (edition Step 4, 4 June 2008) is Pharmaceutical Quality System. Describes a pharmaceutical quality system for the development and manufacture of drug substances and drug products, including biotechnology and biological products, across the product lifecycle.

Question 2

Which markets recognize Q10?

Accepted Answer

United States: adopted, national code Vol. 74, No. 66, p. 15990-1; European Union: adopted, national code CHMP/ICH/214732/2007; United Kingdom: adopted; Japan: adopted, national code PFSB/ ELD Notification No. 0219-1 & PFSB/ NCD Notification No. 0219-1; China: adopted, national code NMPA, China Announcement No. 6 (2020); Canada: adopted, national code File #: 16-101419-273; Brazil: adopted, national code RESOLUÇÃO RDC Nº 658/2022; South Korea: adopted, national code Guideline on Pharmaceutical Quality System [Guideline-0889-01]; Switzerland: adopted; Mexico: adopted; Saudi Arabia: adopted; Singapore: adopted; Taiwan: adopted, national code Public Announcement for ” List for ICH Guidelines 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

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

Market	Status	Edition accepted	National code	Details
United States	Adopted	-	Vol. 74, No. 66, p. 15990-1	Effective April 1, 2009
European Union	Adopted	-	CHMP/ICH/214732/2007	Effective June 1, 2008

Q10 (Step 4, 4 June 2008)

Recognition by market