JOURNEY OF A SPECIAL
When the Pharmacist decides to use a Specials manufacturer he or she has access to expert advice and is assured that the prescription will be prepared in regulatory authority approved manufacturing conditions. The knowledge that the Specials manufacturer will take on legal liability for all of the production aspects of the medicine and for record keeping provides the Pharmacist with peace of mind, leaving him or her free to provide face to face patient care and advice.
Before accepting an order to make a product, the ACSM member will consider if the product is already manufactured in the UK or overseas with a license, or if it is made by someone else on a large scale.
Most likely, he will need to make it himself, in which case he must ascertain if he stock holds the necessary materials, or needs to buy them in. As opposed to a licensed manufacturer, who may buy hundreds of kilos, Specials manufacturers most often buy very small amounts. Nevertheless they must still reassure themselves about how the material is manufactured and obtain Certificates of Analysis.
The bespoke nature of the industry means that Specials manufacturers source and store enormous numbers of formulations and it is equally demanding when it comes to specifying for packaging, There are no standard bottles and the packaging specification needs to be compatible with stability and shelf life parameters, which the Specials manufacturer has established through his research, even though Specials manufacturers order in comparatively small quantities.
In making up the prescribed Special ACSM members have the advantage of specialisation in dosage formats and environment that has been developed to become a centre of excellence and the capacity to make bespoke medicines in small or large batches.
Skilled staff work to standard operating procedures in strictly controlled regulatory authority approved manufacturing conditions with precise and specified systems of checks and double checks before release.
At the end of the manufacturing process the Specials medicines are labelled with handling requirements, storage conditions and expiry dates and The Specials manufacturer delivers the prescribed Special to the Pharmacist. Specials manufacturers provide the Pharmacist with record keeping documentation to ensure compliance and facilitate auditing.
The Association of Commercial Specials Manufacturers Limited. Registered in England and Wales, Company number 05015111, Unit 1, Regents Drive, Lower Prudhoe Industrial Estate, Prudhoe, Northumberland, NE42 6PX. Copyright 2009 ACSM, All rights reserved. Terms of Use