ISO 14971 for Biologics?

[Onceuponatime]

ISO 14971 scopes in medical devices and excludes biological products.

It says:
"and which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means"

Is there a separate standard applicable for Biological products risk management?

 

[Tidge]

I'm ignorant of any such standard.

If I had to speculate: the principles of 14971 could be applied to biologics, but would be complicated for many reasons. Off-the-top-of-my-head: 14971's assessments of risk associated with a designed device are founded within, and primarily the responsibility of, the device manufacturer. Metabolic, immunological, and pharmacological designs (and means of action) are presumably the responsibility of a higher authority.

 

[Sidney Vianna]

Is there a separate standard applicable for Biological products risk management?

If you go to iso.org search for biological risk management (keywords) and filter for standards, you will find a good number of documents.

 

[Ed Panek]

I think its not fit for biologics as part of risk control is missing. You cant change the design of a molecule if that molecule is needed for a specific action but I may be wrong.

 

[Onceuponatime]

I'm ignorant of any such standard.

If I had to speculate: the principles of 14971 could be applied to biologics, but would be complicated for many reasons. Off-the-top-of-my-head: 14971's assessments of risk associated with a designed device are founded within, and primarily the responsibility of, the device manufacturer. Metabolic, immunological, and pharmacological designs (and means of action) are presumably the responsibility of a higher authority.

Thank you.
So in the absence of a standalone standard for biologics risk management, is it a far stretch to use 14971 to do a risk assessment for the biologics manufacturing process? for example, do pFMEA and evaluate subsequent hazards and harms?

 

[Tidge]

My uninformed options will be far less useful than someone with direct experience.

 

[chris1price]

For biological products, take a look at ICH Q9