A small-scale radiopharmacy is a facility where the small-scale preparation of radiopharmaceuticals is carried out in accordance with national regulations.The term small-scale radiopharmacy is not related to the physical size of the facility, but only to the kind of radiopharmaceutical preparation performed.
There are other regulatory or quality guidelines from the European Union and the Organisation for Economic Development.We can provide expertise to the overall validation of any computerised system in research and development clinical and non-clinical functions as well as manufacturing laboratories.Qualification of analytical equipment and computerised analytical systems in pharmaceutical and biotechnology laboratories.Please contact us if you are interested in a detailed offer.The above agenda proposal has been developed for an in-house training course (group of participants).GMP in-house Training Courses are an ideal solution for ten or more people and are very cost-effective.
We come to you at a time and date to suit your organisation.
There are a number of terms and concepts that we need to get right before we start the detailed journey into validation of your software in the following articles in this series.
Process validation is defined as: Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specification and quality attributes [FDA Process Validation Guidelines, 1987].
Services are tailored to a client’s specific requirements rather then provide an off-the-shelf service.
We have over 15 years experience of validating computerised systems that can be applied to solving client problems.
The aim is to provide more detailed and practice-oriented guidance to those who are involved in the small-scale preparation of radiopharmaceuticals which are not intended for commercial purposes or distribution.