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Quality And Safe Product Approval System

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1. Objective
To undertake a critical review of the current product check and release processes to ensure a robust, high quality and safe product approval system is in place to safeguard patient safety and to ensure compliance with standards and recommendations.
2. Background
The aseptic preparation of products at Northern Lincolnshire and Goole NHS Foundation Trust (NLAG) is carried out in an unlicensed unit under Section 10 exemption of the Medicines Act 1968. (1) It requires that the preparation is done by or under the supervision of a Pharmacist, who takes full responsibility for the quality of the product.
Until recently, in unlicensed units working under Section 10 exemption, even if the final checks were carried out by …show more content…

It provides a proposed product approval/Pharmacist supervision model that has been attached in Appendix 1.
Final product accuracy check and release at NLAG is undertaken by the Authorised Pharmacist (usually band 7 or above). The Authorised Pharmacist also undertakes the clinical checks/screening of the prescriptions. It has been discussed that undertaking these checks by different pharmacists will add an extra safety check in the process and there is a plan for separation of these roles in the near future. The plan is to have a Clinical Pharmacist undertaking the clinical checks in the clinical area and an Authorised Pharmacist in the Aseptic Unit undertaking the product check and approval (release). Another proposal has been suggested following this analysis.
There are some concerns regarding separation of the roles as the staff who may be involved in approving products (band 6 pharmacists) have a lack of knowledge and skills in aseptics. There is also a need for cost effective working and flexibility within the service, including appropriate skill-mix. This all emphasises a requirement for this critical analysis to ensure that a robust product check and release is undertaken.
Although errors in the preparation of injectable medicines within pharmacy aseptic environments are not very

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