Outsourcing pharmaceutical analytical services is common, but not without risk. To safeguard against this, it essential that pharmaceutical companies find reliable contract analytical service companies with solid reputations. Daniel Morland, marketing manager at Butterworth Laboratories, shares tips for choosing the right partner.
Daniel Morland: Companies outsource a variety of contract analytical services throughout the product development life cycle. They focus on the confirmation of identity, purity, function and safety of excipients, active ingredients and drug products, as well as packaging and devices.
There are also requirements to analyse patient-derived samples from clinical trials. These requirements are largely dependent on the type of company, the stage of development of a product and the company's in-house capabilities. Services are generally sought when analyses require capital intensive instrumentation and expert labour where the throughput will not provide the economies of scale necessary for cost-efficiencies
There has been a marked increase in the outsourcing of non-core activities by pharmaceutical companies in the past ten years. This is partly driven by capacity and capability limitations but, increasingly, it is a strategic decision aimed at maximising operational effectiveness. It takes advantage of the expertise and efficiencies of the outsourcing partner, reducing timelines and cost. This enables a company to focus its management on core specialisms, improving speed to market while also building a flexible supply network that can drive innovation and growth.
Butterworth has been providing analytical services for over 40 years and supports many pharmaceutical companies from start-up to global top 20. Quality, experience and expertise make the company the ideal outsourcing partner. A well-evolved quality system encompassing the requirements of GLP, GCP and GMP is complemented by vastly experienced personnel in key management and operational positions, many with over 20 years' contract analytical services experience.
This enables Butterworth to add value upfront with advice on analytical methodology and strategy, but also when challenges are encountered with the analysis of materials. It is the timely investigation and resolution of these challenges that can add real value to customers.
The risks can be varied, including strategic, operational, reputational, quality, business continuity and regulatory risks. Outsourcing control of activities, even those that are determined to be non-core, carry risks if not planned and managed appropriately. Divergent strategic intentions can have a negative impact on the relationship's operational effectiveness. Supplier-regulatory non-compliances can lead to issues with continuity of supply, not to mention reputational damage. Poor-quality supply can negatively impact the quality of the product.
Appropriate evaluation and planning of the outsourcing process will help identify, evaluate and mitigate risks. Well-managed execution and ongoing management are also vital to maintaining an advantageous outsourcing strategy. Building partnerships with outsource providers is key to this process; it may sound a clichéd statement, however, its importance cannot be overlooked.
This is obvious when considering research activities to ensure that the needs of the sponsor are understood and delivered within appropriate timeframes and cost boundaries, however, it's equally important for the more routine qualification of materials for manufacture to ensure consistent market supply.
Good working relationships are vital. Both parties should work together to ensure the process is enhanced by an underlying understanding of each other's needs. This will minimise delays, increase overall efficiency and save money. Good relationships ensure regular, honest feedback to achieve iterative reviews and improvement to the working relationship.
Visit their facilities; meet with key operational and management personnel. Does the company have the expertise and systems in place to deliver your requirements? Also, get a feel for its culture. It's not just a question of quality, capability and cost. You have to ask if both parties' key stakeholders can work together to add mutual value. Is there a culture of continuous improvement? This is especially important when challenges occur. Finally, an outsourcing partner must have a good track record of solving analytical challenges and preventing reoccurrence.