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Pharmaceutical Manufacturing and Packing Sourcer

Perfect Match

The selection of an experienced build and test partner is critical to the success of any new complex equipment manufacture. This article examines the selection criteria that R&D, product development and pharmaceutical organisations should employ to ensure their partner of choice really can deliver.

There are criteria by which potential suppliers should be measured. Facilities, experience, technical capability, quality assurance procedures and track record are all factors that must be taken into account. But that is not all – there are smaller, more intuitive issues to consider too. How will the project be managed? Is the supplier a ‘can-do’ company?

Does it understand the end game? Will it create more complexity or simply get the job done?

Partner Assessment

The values of the supplier are often overlooked, yet are an important consideration. A motivated partner will bring to its customers a closer, more proactive relationship that can often be the difference between success and failure. This can deliver all kinds of benefits: faster build time, effective planning, open visibility on costs and validated testing – all of which provides confidence that the end product is fit-for-purpose.

Customer focus should be a cultural attitude that embraces every aspect of the supplier's business, not just at the personal relationship level. This can be demonstrated in a number of ways but, in essence, a manufacturer that is constantly striving for excellence, applies common sense, and is committed to deadlines reflects the indicative values of an organisation that puts customers first.

Matching Skills

Consideration should also be given to the structure of the project team. Ideally, both organisations should have omplementary teams where a level of technical expertise is matched on both sides. This means that design engineers can talk to design engineers, and project managers can talk to project managers. Without this ‘meeting of minds’, tasks can be slowed or become over-complicated simply by misunderstandings. It is important to look for a supplier that can demonstrate a broad range of team-working and communication styles that suit your organisation.

Regulatory compliance and quality are key factors in any selection process, but again, the consideration starts with the needs of the customer. Regulatory issues are much more robust for equipment that comes into contact with an active pharmaceutical ingredient. Equally, fitness for purpose is a key measurement; there is little value in appointing a class 10,000 cleanroom manufacturer when actually what is required is a non-cleanroom manufacturing environment.

Continuous Improvement

Suppliers should provide fact-based planning rather than reactionary decision-making, and should be able to guide customers through the product development process in a pain-free, efficient manner. They need to provide a platform for continuous, wide-ranging improvement throughout the lifecycle of a product: from consistently improving the supply chain to continually reducing waste; and from yielding higher quality standards to a lower cost of manufacture over time. More than anything else, suppliers need to deliver intelligent manufacturing solutions.

In addition, manufacturers have a duty to ensure they offer their partners the best possible value. In essence, this requires them to apply a philosophy of continual improvement throughout their business so that products are manufactured in the most efficient, effective and value-driven way possible. Too often it is thought that cost savings can only be achieved by reducing profit margin, but this route is neither sustainable nor realistic. Manufacturers must seek out efficiencies in other areas, primarily through process improvement and waste elimination. There may also be efficiencies in product development, though the level to which improvements can be made is entirely dependent on the regulatory constraints for that particular product.

Many improvements can, and do, come from field visits – there are examples where the engineering services managers who built the equipment are the same people who install them, train the operators, and provide service and support. The intimacy with which they understand each machine makes the service seamless, providing everyone with absolute confidence that they are being well-supported, and able to interpret and act upon customer/user insight.

Eradicating Bad Days

‘Bad days’ can potentially have a long-term impact on the viability of the end-user's business. Whether bad days are derived from unforeseen glitches or more systemic process issues, without an appropriate and timely resolution, the ultimate sanction can be significant business interruption and loss of revenue. The prevention of such issues is best served through a structured problem-solving methodology that delivers the necessary improvements in business process. By identifying the underlying cause and establishing best practice to ensure the solution remains in place, the number of bad days can be radically reduced and systemically eradicated.

The maintenance of quality does not just sit within the four walls of the supplier's manufacturing facility. A robust, qualitative and ongoing assessment of the whole supply chain should be evident. There is little point in controlling quality inside the plant if the standard of the quality systems within incoming materials and component suppliers are allowed to compromise efficient production. Manufacturers should be able to demonstrate their ability to qualify a supply chain, and work from an approved supplier base where incoming quality is assured.

Lifecycle Management

Cost reduction schemes are often a starting point in the creation of an ongoing programme of continuous improvement. The strategic target for all manufacturers should be to minimise waste in the business, as well as an overall reduction in operating costs. A commitment to waste reduction should run right through the business and, while management focus is important, it is often ‘employee buy-in that is the decisive factor. This well-rounded approach contributes to greater consistency in people and processes, ensuring an all-round better service for the customer.

In scaling-up rapidly, the transition required to deliver the necessary production levels while maintaining quality standards can be complex – and stepping up production with an acceptable level of risk requires careful and experienced management. Enlightened suppliers will offer a scalable manufacturing approach.

As we have identified, effective lifecycle management can contribute positively to the commercial success of equipment throughout its life, but is perhaps most critical when volumes begin to fall. Great importance should be placed on the capability to manufacture products in the most appropriate and sustainable way. Scalable processes and flexible manufacturing facilities should be employed during the course of development and beyond; and as the product reaches maturity and moves toward the end of its life, this scalability becomes important once again. As production volumes start to decline, an intelligent manufacturer can allow for the introduction of different scheduling methods, and perhaps switch from full-time to ‘campaign’ manufacture.

Best Partner

The key criteria for the selection of a manufacturing partner should be based on their competencies and demonstrable track record in building and testing complex manufacturing equipment. Only by having a comprehensive understanding of all the factors involved are constructors able to create products that are fit-for-purpose.

The investment that design houses and R&D departments make in developing new equipment is considerable. In order to ensure that the end product has the best possible chance of sustained and profitable success, the choice of manufacturer is critical.

Customers need to choose a partner they can rely on – a partner that will never compromise on a project – and one that can add value. Without these necessary qualities, projects can be delayed, budgets can be increased, and the end product may not fulfil its purpose. Expertise is fundamental, experience is critical, and a culture of ‘can-do’ is paramount. Without such core values, your manufacturing partner may not be able to deliver the product you need on time or on budget.

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About the author

Julie Dean is Managing Director of NEXUS Intelligent Engineering, where she is responsible for the strategic direction and profit and loss performance of the company. She works with an expert, agile team who are constantly seeking to provide intelligent engineering services by delivering precise solutions for clients.

Julie Dean
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