A Performance Management Tool

Lot Traceability Systems are used in industries where there is a very strong requirement for product integrity and for the ability to recall delinquent products containing similar component mate­rials should a critical defect be found. Among these industries are

• Aerospace, where each critical component is normally indi­vidually numbered and recorded at every stage of manufac­ture, assembly, shipment and use.

• Pharmaceuticals, where the requirements for lot tracing are dictated by the regulatory or advisory requirements incorpo­rated in the Good Manufacturing Practice (GMP) code for the manufacturing or consuming country or both. [3]

• Medical products, such as surgical equipment and implantable devices—e.g., heart pacemakers, where there is a separate but similar GMP code.

• Food, cosmetics and similar non-ethical products that are bound by similar conditions or where it is necessary to maintain similar records.

This paper will be limited to pharmaceuticals and by extension to analogous products such as some medical products and cosmetics. Clearly the even greater amount of detailed information generated and maintained for aerospace components and assemblies should permit similar approaches.

A Lot is a quantity of material manufactured or purchased at the same time under the same conditions and that therefore should be homogeneous. This definition of a lot is interpreted with varying degrees of rigour, generally because the implication of separating production into lots is that each lot has to be recorded separately. The word batch is sometimes used to mean a production quantity, but only lot has a precise and universally accepted meaning for traceability.

For pharmaceuticals, then, a key requirement of GMP is Recallability. This specifies, Inter alia, that it must be possible

• To identify by lot every separate manufacturing quantity of finished products from information shown on the product itself or its packaging.

• To identify all quantities and lot identities of all component materials making up the product itself (at any level) and of all

materials in contact with the product that could affect its properties, e.g. tubes, bottles, and of all printed materials that could affect its mode of use, e.g. cartons, labels.

• To identify all other lots of any product, wherever they may be situated in the distribution chain, which contain any quantity of any of those materials.

• To account at all times for all quantities of every lot of all lot traced materials.

• From the records to determine which lots need to be recalled from any point in the supply chain in the case of a fault at any level in any of the component materials that are lot traced, and to perform such a recall.