Liquid oral unit dose

Hello we are looking for sop to produce unit dose of liquid oral medication.
What could de the best performance qualification tests

You question is not clear. Please clarify the question.

  • Do you want to write SOPs for manufacturing of oral liquid preparation?
  • What is unit dose?
  • Is it a clear liquid, syrup or suspension?
  • Which drugs do you want to use in oral liquids?
  • What are the major pieces of manufacturing equipment do you want to use?
  • What are the major pieces of packaging equipment do you want to use?
  • Any other important informaton

Also please note that before conducting Performance Qualification (PQ) of manufacturing equipment & packaging machines please conduct DQ/ IQ/ OQ. You will have to write protocols of DQ, IQ, OQ, PQ with the help of suppliers or fabricators / manufacturers of these equipment.

Dear sir

Oral unit doses are Amal Vial filled with 50 microliter to 10000 microliter of oral medication ready for one administration.

We are looking for a sop or specification of weight variation test four the doses and filling volume accuracy

Yours sincerely

Is this product a generic drug ? And in which pharmacopoeia it belongs to? Is it a USP monograph?
Is it only 50 microliter oral dose? Is it required to be diluted with water?
If it is a monograph then please follow weight variation procedure & volume accuracy as per that pharmacopoeia. Otherwise please follow general requirements of weight variation according to USP / BP/ IP as per the regulatory requirements of that market in which the drug product is to be sold.