In PA's experience there are four crucial aspects to achieving excellence in life sciences manufacturing:
- effectiveness in supply chain
- effectiveness in resource management
- compliance
- excellence in machine design.
Effectiveness in supply chain
Supply chain effectiveness can be achieved only if three challenges are met. These relate to future manufacturing capacity, supply chain leakage and new product innovation.
Understanding your future manufacturing capacity demand and determining optimal plant allocation strategy is complicated by the problem of scale-up during drug development. Build too much or too soon and you erode profit; build too little or too late and you fail to realise maximum future profit.
PA has a world-leading options modelling capability which allows manufacturers to make informed and sophisticated decisions. Managing supply chain leakage during distribution is a growing and formidable challenge as re-entry of drugs from access to medicines programmes and counterfeiting take their toll. We know that our product authentication expertise and supply chain tracking, based on RFID technology, will be crucial here.
Effectiveness in resource management
Effectiveness in resource management requires the linkage of strategic planning, capacity planning, and scheduling and rostering. This is easy to say but incredibly hard to achieve. PA has demonstrated world-class solutions in this arena, delivering 30% improvements on already highly efficient systems.
Compliance
Compliance, the third aspect of excellence, requires expertise in regulatory, legal and risk domains, something PA has in abundance. PA delivers several pharmaceutical automation projects every year. Most of these projects require compliance to 21CFR11. In delivering compliant systems, our approach is to focus on the spirit of the regulation. The recent release of the FDA's guideline on scope and application has highlighted the advantages of this approach. However, we recognise that our clients' needs may differ and so we remain flexible.
In the past, our approach has utilised four avenues :
- focus on predicate records
- piggyback on existing security
- develop within a quality system
- produce a single electronic record of all that has occurred.
Excellence in machine design
PA has a broad range of services and experience in machine design, which includes:
- multiple industry experience providing creative solutions through cross-fertilisation
- on-site tools and processes enabling fast and efficient equipment development
- engineering, specialised technologists, and applied physicist support
- process and machine audits
- process and machine cost reduction projects
- manufacturing profile assessment
- management and implementation of new processes
- development of high-speed, on-line quality control equipment: mechanical, optical and sensing systems.
Further information
For further information please e-mail: healthcare@paconsulting.com
