Controlling materials and maintaining chain of custody flow during the process of manufacturing pharmaceuticals can be a challenging task. Navigating the many unit operations can be quite complex as product intermediates are passed on from one group to another. This is particularly the case with the manufacture of biologicals. Once process break points are introduced, as in the case of the protein drugs during clarification and concentration steps prior to purification, there is the possibility that individual lot “parts” may be lost or mislaid, or there’s the potential for a mix up with some other drug product if a label becomes detached. This can be a real circumstance where materials are being cooled and subject to situations where condensation occurs. As a result, having a robust mechanism to assure reliable identification is vital if deviations are to be avoided and the possibility of FDA (regulatory agency), citations are to be eliminated.
Often, as pharmaceutical consultants, we find that in an attempt to secure the possibility of avoiding such deviation issues, pharmaceutical, biotech and other Life Science companies try to over compensate by engaging secondary and tertiary personnel checking mechanisms. Unfortunately, often these do not meet the intended compliance requirements, but instead provide additional possibilities for human error deviations associated with newly introduced documentation errors.
Frequently this is caused as a result of companies requiring personnel to provide too much information on labels intended for internal transiting, which inevitably become sources of errors, due to incomplete or incorrect entries.
To avoid this operational trap, it’s better to develop a strategy that uses only the absolute minimum information to assure correct handling and tracking of the material, in much the same way as one might use in a warehousing (ERP)system. To enable such an approach, what’s required is a suitably adaptable materials management /ERP software system that can be used to code for the in-process or finished product materials. Using this in combination with barcoding scanning devices in-built into tablets that can be used by shop floor operations, staff can track process operations, (as in the case of product batch records), it’s possible to provide a Lean efficient and compliant mechanism to control and track material movement and disposition through the production process.
An approach developed by SMART Pharmaceutical Consulting, utilizes a four-bit code of information which can be used in a suitable bar-coding format to appropriately control and track all materials involved and handled in the pharmaceutical production process.
By operating as a four-bit code for either finished product or in-process situations ( as an efficient, simple elegant solution), it is easy to develop that to effectively remove any issues currently causing quality compliance problems, particularly those associated with tracking the flow of product intermediates, during the product manufacturing process.
As an example, for in-process control, we have found the following pieces of information to be the critical ones.
• Weight in bag or container
• Batch/lot #
• Part # (part 1 of N in a lot of bulk drug product).
• Date of manufacture
…and incorporating a bar code.
With just these four pieces of information, it should be possible to maintain total control of the process/product/materials throughout the complete manufacturing cycle, and in doing so, meet cGMP expectations described by regulatory agencies.
For further details. contact us at
610-422-1097 or 1-833-GMP-LEAN.