Active Pharmaceutical Ingredients (API’s), used as ingredients in sterile medicinal products,
must be sterile unless the final dosage form is terminally sterilised, or produced by a process
including a sterilising filtration step. API’s intended for use in parenteral products must also
comply with relevant specifications on pyrogens or bacterial endotoxins.
The manufacture of sterile API’s must be strictly controlled in order to minimise the risk of
contamination with micro-organisms, endotoxins and particles. If the final dosage form is not
to be sterilised by filtration, the API’s should be practically free of particles.
must be sterile unless the final dosage form is terminally sterilised, or produced by a process
including a sterilising filtration step. API’s intended for use in parenteral products must alsocomply with relevant specifications on pyrogens or bacterial endotoxins.
The manufacture of sterile API’s must be strictly controlled in order to minimise the risk of
contamination with micro-organisms, endotoxins and particles. If the final dosage form is not
to be sterilised by filtration, the API’s should be practically free of particles.
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