* Clear, legible<ref name=EUGMP4 />{{Page needed|date=October 2022|reason=Cannot find this in the document; needs additional reviewer to confirm.}}<ref name="WHO4">{{Cite techreport |url=https://apps.who.int/iris/bitstream/handle/10665/44079/WHO_TRS_961_eng.pdf |chapter-url=https://apps.who.int/iris/bitstream/handle/10665/44079/WHO_TRS_961_eng.pdf#page=106 |last=WHO Expert Committee on Specifications for Pharmaceutical Preparations |title=FourtyForty-fifth Report |number=961 |institution=[[World Health Organization]] |date=2011 |series=WHO Technical Report Series |chapter=Annex 3. WHO good manufacturing practices for pharmaceutical products: main principles |url-status=live |archive-url=https://web.archive.org/web/20220901051256/https://apps.who.int/iris/bitstream/handle/10665/44079/WHO_TRS_961_eng.pdf |archive-date=15 October 2022 }}</ref><ref name=MHLW169>[http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf Japan MHLW. Ministerial Ordinance No. 169, 2004, "Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostic Reagents" (Chapter 2, Section 2, Article 8, Paragraphs 2 and 4)] {{Webarchive|url=https://web.archive.org/web/20110722105510/http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf |date=22 July 2011 }} – Accessed 7 January 2011</ref>
* Errors are not introduced<ref name=EUGMP4 />{{Rp|___location=¶4.2}}<ref name=WHO4 /><ref name=FDAJ />
