With the increasing need for businesses to reduce costs and demonstrate value, there is a requirement to look at all aspects of bio/pharma drug development and manufacturing to achieve efficiency improvements, including how quality and compliance are managed. The author investigates how GXP best practice should be implemented and how lean methodologies can improve efficiency and compliance.
The International Society for Pharmaceutical Engineering (ISPE) Baseline Guide and Good Automated Manufacturing Practices (GAMP) documentation provides an excellent foundation upon which to base risk assessment. In accordance with these guidelines, it is necessary to conduct an objective assessment of each system and activity. It is important to challenge the way things have been done historically, as well as the way things are done in different parts of the organisation, as these may not always be the most appropriate solutions.
For instance, the classification of environmental conditions for a work area can have a significant cost impact in terms of design, installation, validation and ongoing monitoring. For pharmaceutical companies, it is important to consider whether reducing the classification across elements of drug manufacturing can have an impact on product safety. By challenging the classification necessary to conduct GMP/GLP operations within an environment that is adequate for the operation, companies may be able to achieve significant savings. A value engineering study must challenge all areas of drug development and manufacturing, including quality, and must not be restricted to new facilities, as the robust review of existing facilities is also often beneficial. The importance of lean
As with any quality system, the route to success involves setting out 'policies' to communicate what the organisation wishes to achieve, the 'guides' for how this should be done (principles), the details of how this must be completed (methods) and the measurement system and expected results by which success and adoption will be measured. Fundamental to the success of any lean compliance programme is buyin from the organisation and readiness to change. This is a change management project and must be managed appropriately — a brilliant idea will remain just an idea if it is not clearly communicated and adopted with the necessary understanding of its purpose and benefit.
Lean compliance case study
The following real life example demonstrates how lean compliance can result in significant cost and time savings for the release of Clinical Trial Material (CTM).2
A lean compliance initiative has been implemented within a leading CMO to reduce the time and cost needed to review and release CTM. To be successful, the quality approval process was mapped, documented and explained to all key stakeholders to create a collective understanding of the operation. Through the use of lean methodologies, the quality control/quality assurance cycle time was reduced from more than 200 days to 56 days — a reduction of 72% of the original time taken. These recommended process improvements — based around changes to the quality function within the business, e.g., review, approval and communication of quality records and data — were incorporated into standard operating procedures (SOPs) for release of CTM and have enabled knowledge sharing between different sites of the CMO, significantly enhancing business processes, knowledge sharing and profitability.
Using a true riskbased approach to quality and compliance is an essential component of ensuring that an organisation not only fulfils its regulatory requirements, but also does so with a clear understanding of the priority and relative resources that should be given to each element. It also enables identification of those areas that do not have any notable impact on patient safety or GXP data integrity, providing justification for eliminating or ignoring these.
Lean compliance is a business process efficiency concept used to ensure that GXP best practice is achieved as efficiently and effectively as possible. By carefully using proven and established lean methodologies and tools, the quality and compliance functions of an organisation can be challenged. Lean compliance establishes the true valueadding operations within a business and looks at how these can be maximised. It decides which business value operations are necessary to ensure compliance, and how these can be simplified and reduced. It also highlights the non valueadding operations that can be eliminated and prevented to save time and cost. The objective is to truly challenge each component of a process and determine whether it is really essential. The main question is whether something is being validated because it has always been done that way or because it really has an impact on quality, compliance and, most importantly, patient safety.
The key to success with any lean compliance project is the same as any good business or project management practice — establishing key objectives, clear communication throughout the group, and maintaining the focus and support needed to drive and measure success.
Mark Stevens is Operations Director at GxPi.
1. Pharma iQ, "Do Electronic Submissions Save Pharmaceutical Companies Time? 62% says Yes!" (2010). www.pharma-iq.com
2. Data on file at GxPi.