Higher Voluntary Standard

Higher Voluntary Standard (HVS) seed is an enhanced standard which applies to the United Kingdom only and means that the seed has been tested to a higher standard than the prescribed minimum standard in the EU directives. Seed meeting HVS standards is labelled accordingly. 

The Agency agrees that, when a voluntary standard is used in a regulation, the scope of that standard should be unambiguously expressed. As stated above, a basic tenet in the development and adoption of a standard is that it contributes to safer, more effective, and higher quality products. Inappropriate application of a standard (voluntary or as part of a technical regulation) would run counter to this notion. 

The third voluntary standard is The International Society of Pharmaceutical Engineer s (ISPE) Baseline Pharmaceutical Engineering GuideS This is one of a series of ISPE guidance documents that has limited endorsement by the FDA. It should be understood that only minimal standards are being endorsed and there are many reasons why specific sterile products and applications could be seen by the FDA to require compliance with higher standards. 

Sometimes, local standards may originate from requirements of a higher level of regulation. For example, the Joint Commission for Accreditation of Healthcare Organizations (JCAHO) (formerly the Joint Commission for Hospital Accreditation (JCAH), a voluntary organization (but an organization... 

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