Contract for the provision of pharmaceutical monitoring and validation testing for the Pharmacy Department of The Dudley Group NHS FoundationTrust

SPECIFICATION

1. Introduction

1.1 The Dudley Group NHS Foundation Trust (Trust) requires an organisation to provide comprehensive Pharmaceutical microbiological monitoring and validation testing with quality assurance support. The quality assurance services provided under this contract are essential to ensuring that the Trust's Pharmacy Aseptic Unit complies with all the necessary regulatory requirements.

1.2 The range and estimated annual activity of the services the Trust will require to be carried out are as follows:-

Service Estimated Number of Tests per annum Media Settle Plates (TSA) and (SDA) 18,000 Finger Plates 2,500 Contact Plates 3,100 Surface Swabs 1,000 Active Air Samples (Plate) 1,000 Broth Transference Test (Excluding Kit) 30 Broth Transference Test (Shield Kit) (Inclusive of Kit) 80(sets) Sterility Tests 52 End of Session Media Fill (Including Kit) 210

Please note that the activity under this contract is estimated to increase by 5% per annum.

1.3 The Trust will have the following responsibilities under the Contract:-

1.3.1 The Trust will be responsible for arranging packaging and transportation to the Contractor of any samples for analysis. Samples will be labelled with a batch number or another suitable identification code. 1.3.2 The Trust will ensure that samples will be accompanied by a written instruction from the Trust to carry out testing according to a nominated, supplied specification and analytical methods. 1.3.3 The Trust will endeavour to give the Contractor 48 hours, and not less than 24 hours, prior notice of extra ad hoc delivery of samples that are outside of the agreed sessional / weekly/ monthly monitoring schedule.