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QPs to review quality

From Mr J. R. A. Baker, MRPharmS


Procedures advocated by Robert Lowe (PJ, 24 November 2012, p596) to ensure specials are of the correct quality are duties carried out all the time by Qualified Persons for licensed medicines.

Might it not be advisable for all specials manufacturers to have a QP available to review the quality system and all relevant documents and, if satisfied, issue a certificate to the ordering pharmacist confirming that the product has been made to current good manufacturing practice standards, ensuring the quality and safety of each special manufactured?

Perhaps it is time for regulatory authorities to insist a QP is on the specials manufacturing licence.


John R. Baker

Qualified Person

Bury St Edmunds,

Suffolk

Citation: The Pharmaceutical Journal URI: 11112381

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