CI Precision has developed a configuration of its Ci-DMS Manufacturing Execution System (MES) specifically for those pharmaceutical manufacturers that hold “specials” licences from the MHRA (Medicines and Healthcare products Regulatory Agency).
Proven in the Boots Contract Manufacturing Specials factory where hundreds of orders are processed every day from a list of thousands of recipes, it is now being offered to other pharmaceutical manufacturing units (PMUs), including those attached to hospital pharmacies.
Currently such PMUs typically use paper-based systems to manage the production of creams, ointments, tablets and capsules, but there are many advantages to be obtained by switching to a MES. Not only does a software system improve the traceability and reduce the risk of errors being made, but it also has the potential to improve the operational efficiency. For example, the normal procedure with a paper-based system is to have two people check the weights of pharmaceutical ingredients and the recording there of in order to comply with good manufacturing practice (GMP); an automated recording system, however, eliminates the requirement for a second operator to be present. Ci-DMS ensures that manufacturing is secure, consistent and controlled.
Indeed, the system helps to manage the entire execution process and, at the same time, builds a complete audit trail. Ci-DMS positively identifies the raw materials and the batches/lots from which they have been taken, it checks the QC (quality control) status and the expiry date of the lot being used, it checks the operator ID and password, it presents the operator with any relevant health and safety warning, it records all weights and scale calibration data, and it prints barcoded labels containing all of the required information – including the end product for which the ingredients have been prepared.
Ci-DMS is a highly configurable standard off-the-shelf system that can be configured and validated to each customer’s requirements.
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