Given
the importance of sterile products, in providing both a therapeutic medicine
and with regards to the necessity of being free from viable microorganisms,
pyrogenic substances and visible particulates, no new guidance has been issued
by a regulatory authority in recent years. This has changed with a new draft
guidance document from the European Medicines Agency. Issued in April 2016 for
public comment, the document is titled Guideline on the Sterilisation of the
Medicinal Product, Active Substance, Excipient and Primary Container.
Tim
Sandle’s review of the new European Medicines Agency guideline has been
published in Industrial Pharmacy.
The
reference is:
Sandle,
T. (2016) New EMA draft guideline on sterilisation of the medicinal product,
Industrial Pharmacy, 51: 14-15
Posted by Dr. Tim Sandle
No comments:
Post a comment
Pharmaceutical Microbiology Resources