ADE:
Accepted Daily Exposure:
Daily dose of a substance below which no adverse effects are anticipated, even if exposure occurs life time.
ADE(mg/day) = NAOEL(mg/kg/day) X BW(Kg) / UFC X MF
Where
[COLOR=“darkred”]ADE= Accepted Daily Exposure
NOAEL =Not-Observed-Adverse-Effect Level
BW = Body weight
UFC= Uncertainity Factor(s)
MF= Modifying factor[/color]
This is becoming an important factor in Risk based cleaning of a Equipment which is being used in a facility where multiple products are manufactured.
Residue limits should be practical, achievable, verifiable and based on the most deleterious residue. Limits can be established based on the minimum known pharmacological, toxicological, or physiological activity of the API or its most deleterious component.
Special thanks to Jeffry Hartman Validation Manager, MMD Validation Quality Assurance, MERCK/ Group Leader, PDA Quality Risk Management Interest Group.Last morning at 11.am EST he explained this in a seminar conducted by Alfalavel on Risk based Qualification of Equipments.
Regards
[quote=DURGA PRASAD]ADE:
Accepted Daily Exposure:
Daily dose of a substance below which no adverse effects are anticipated, even if exposure occurs life time.
ADE(mg/day) = NAOEL(mg/kg/day) X BW(Kg) / UFC X MF
Where
[COLOR=“darkred”]ADE= Accepted Daily Exposure
NOAEL =Not-Observed-Adverse-Effect Level
BW = Body weight
UFC= Uncertainity Factor(s)
MF= Modifying factor[/color]
This is becoming an important factor in Risk based cleaning of a Equipment which is being used in a facility where multiple products are manufactured.
Residue limits should be practical, achievable, verifiable and based on the most deleterious residue. Limits can be established based on the minimum known pharmacological, toxicological, or physiological activity of the API or its most deleterious component.
Special thanks to Jeffry Hartman Validation Manager, MMD Validation Quality Assurance, MERCK/ Group Leader, PDA Quality Risk Management Interest Group.Last morning at 11.am EST he explained this in a seminar conducted by Alfalavel on Risk based Qualification of Equipments.
Regards[/quote]
How to arrive at acceptance criteria for cleaning validation in biological facility?
How to demonstrate it that the residues of previous batch/cleaning agent are within acceptable level ?
What are the rationale for fixing parameters for vaccine & therapeutics?
Elaborate & detailed reply with example shall be highly appreciated.
Thanks & Regard
Ravi Dhanbhar
Please refer latest PDA technical report on Biologiocal cleaning and validation. It is now followed across EU and USA.
I do not have that technical report number right now. You must purchase that for a price of 250dollars.
Members from PDA forum are bound with a non-disclosure polocy.So no one shares these details. The needed ones should download that whole document and it is available in electronic format (PDF), 45 PAGES.
Regards
It is PDA technical report No. 49. it was published in Q4. We are in process of purchasing it but I am not much optimistic about the its contents providing practicable solution in detail to my queries.
Thanks for information.
Regards
Ravi Dhanbhar