Having made a number of different API manufacturing choices in the pharmaceutical industry over the past years, I’ve learned some hard-earned lessons – some through triumphs and, let’s face it, some through painful potholes.
If you’re a startup gearing up for scale, or a large incumbent seeking to innovate or outsource, choosing the right API manufacturer in the UK could make or break your product. Here’s what I’ve learnt about finding the right partner.
Understanding Your Needs
First, it’s important to understand your needs: are you looking for large-scale production capability or a smaller, bespoke service? The manufacturer you choose should fit your project closely.
Scale and Flexibility
If you need the volumes you can get from large-scale manufacturing operations that have the facilities and supply chains to handle those volumes, then this is an advantage. On the other hand, if you need flexibility for smaller (possibly more nimble) projects that might change course on short notice, then this is an advantage of smaller manufacturers. They are more nimble and less encumbered by the bureaucracy of large-scale manufacturing.
Technological Capability
Consider the engineering capabilities of your API manufacturer. Partnership with a company that invests in state-of-the-art technology and manufacturing processes and takes continued process improvements seriously can help ensure the quality and effectiveness of your product. Advanced technology is not just about cost effectiveness; it is about providing a product that can stand out in a competitive marketplace, and that stands the test of time.
Regulatory Compliance: Navigating the Legal Landscape
This is the big one. In the UK, the API manufacturing landscape is highly regulated, and that’s a good thing. In fact, the most expensive part of setting up your product is likely to be making sure your manufacturer is not only compliant with the current regulatory environment but also anticipating forthcoming regulatory changes.
Regulatory compliance is no mere checklist item but a keystone of your operational integrity and market viability Your product must survive the intricate web of local and international regulatory obligations. Selecting a manufacturer that not only complies with these regulations but anticipates changes in them can make the difference between the sustainability and viability of your pharmaceutical projects.
The Criticality of Compliance
When it comes to API manufacturing, the list of compliance requirements is virtually endless: it involves environmental standards, occupational health and safety standards, cGMP quality controls, export restrictions, and much more. There are different sets of regulation for different markets, and sometimes the differences are staggering.
1. Domestic vs International Standards
In the UK, there are guidelines drawn up by the Medicines and Healthcare products Regulatory Agency (MHRA) that make it clear that all medicines ingredients produced or imported to the UK are done so with the highest standards of health and safety. However, if your end product is going to be exported, your manufacturing partner will need to ensure that what they are producing complies with international standards (eg, the US Food and Drug Administration [FDA], the European Medicines Agency [EMA]).
2. GMP Certification
Good Manufacturing Practice (GMP) ensures that products are consistently produced and controlled according to quality standards. It is designed to minimise the risks involved in pharmaceutical production that cannot be eliminated through finished product testing. A GMP-certified manufacturer is mandatory – this certification is recognised globally and is often a requirement for entering new markets.
3. Audits and Inspections
Regular audits and inspections are an inescapable fact of life for any API manufacturing facility that wishes to operate above board. Your chosen supplier should be subject to regular evaluations by the relevant regulatory authorities, whose monitoring ensures that they are adhering to the requisite legal standards day-to-day. Ask about how many audits a potential supplier has undergone in the past, how often they are inspected and what remedial measures, if any, have been required as a result. A good audit record is a reassuring sign of your manufacturer’s credentials.
4. Adaptability to Regulatory Changes
The regulatory world is never static: new scientific findings, public health scares or shifts in politics can all spur adjustments to regulation. A responsible manufacturer is proactive and engages with regulators, joins industry groups, and adapts operations in anticipation of new compliance challenges.
The Importance of Expertise in Regulatory Affairs
Since regulatory compliance is so complex and so vital to your business, you should look for a manufacturing partner who has a regulatory affairs team. Its job is to keep abreast of regulatory developments and ensure the company’s compliance, and advise on the regulatory effects of any new business activities or markets you want to explore.
But regulatory compliance in API manufacturing isn’t just about avoiding fines or product recalls; it’s about establishing goodwill with your clients and the regulators. It’s the underpinning for everything you do and, from time to time, is the difference between the commercial success or failure of the pharmaceutical products you are supplying. If you select a manufacturer whose processes reflect an unwavering commitment to current regulatory requirements and who seems to be able to anticipate regulatory changes before they occur, it’s not just good practice – it’s a strategy for protecting your product and your company.
Cost vs Quality
The quest to find the best value along the cost-quality axis has been the most daunting step in the process. At the bottom end of the cost axis, price can be a major determinant of quality, while the opposite is not true.
Transparent Costing
Find a company with an open cost structure. Costs are the most insidious item that can balloon your project budget. With an open cost structure, your manufacturer should not only share the cost with you upfront, but they should tell you in advance if there are tentative increases in cost such as a change in project scoping.
Quality Assurance
Don’t accept anything less than a commitment to quality assurance. The best manufacturers include quality control as part of the production process, and they should be prepared to share data regarding the testing of products and quality metrics.
Customer Service and Communication
I have learned over the years to never underestimate the power of good communication. A manufacturer who sees themselves as part of your team will greatly enhance your experience, and probably your project’s success.
Proactive Communication
Work for a company that believes in transparency and wants to talk frequently. This will keep the lines of communication open so that you can solve any problem and make informed decisions.
In conclusion, the selection of an appropriate UK API manufacturer is not an easy task and this is mainly because of the fact that you need to deeply understand your requirements and do extensive research on the right manufacturer who can provide you the services that you are looking for with full conviction and confidence. Through my journey I have learnt that the right partnership not only helps you mitigate the risks but also elevates your product beyond your conscience in ways that you might not have ever thought of before. Trust can never be bestowed upon, it can only be built in the process of success and failure together.