APSM

What to look for in a Specials Manufacturer For anyone looking for a Specials supplier, this article in Independent Community Pharmacist gives some useful advice.  Sourcing Specials Or you can check out the information on our APSM website which lists the quality criteria required of holders of an MHRA specials manufacturing licence.  It also includes some of the additional services provided by APSM member companies. APSM website

The APSM, Association of Pharmaceutical Specials Manufacturers, is reminding pharmacists of the importance of 24 hour turnaround for bespoke Specials prescriptions.  All APSM members sign up to a commitment of timely delivery to patients 1 and for all members that now means next day delivery as standard.     Members report that between 95-99% of orders are despatched the same day of receipt for delivery the following. Said, APSM Chair Sharon Griffith, “What may have started as an effort to offer competitive advantage – we’re happy to say is now the norm amongst APSM members which is good news for patients.   Patients who are prescribed Specials often have a specific and urgent clinical need - they should not have to wait for this medicine just because it isn’t a licensed or off the shelf preparation.” Although Specials manufacturers are geared towards bespoke manufacture it can still present a challenge.  With more than 20,000 potential preparations o...

QUALITY PROCESSES FOR UNLICENSED MEDICINES Unlicensed medicines, or specials, are only offered to a patient when the physician has identified a clinical need that cannot be met by any available licensed alternative.   In the UK, the majority of specials are manufactured and prepared by Specials manufacturers who are licensed, regulated and inspected by the MHRA and must comply with the principles of Good Manufacturing Practice (GMP) adopted by the EU Commission.   These licensed manufacturers provide additional assurances of quality.   A certificate of analysis is provided for batch manufactured specials as evidence that critical parameters have been met through physical, chemical or microbiological analysis of the final product.   Where individual or bespoke specials are prepared, the manufacturer will provide a certificate of conformity to show that the product meets the specification. In addition, (ALL) APSM members voluntarily undertake to apply th...