How Smart Buyers Choose Pharmaceutical Equipment Suppliers 2017
Pharma Supplier Checklist 2017: What to look for in a pharma supplier
With increasing industry expectations that pharmaceutical equipment and facility design is considered as part of the product Quality by Design process, procurement managers need to work much harder to eliminate buyer information silos in order to meet unique sourcing challenges and stay up to speed with competitors and their procurement teams and the suppliers they trust. The smart buyers, procurement teams and key decision makers in the process need to consider key factors before purchase.
There are a number of key factors that you should look for when identifying and short listing possible pharmaceutical machinery, equipment and excipient suppliers. Quality pharmaceutical machinery suppliers should be able to demonstrate that they can offer you the following important benefits that will help ensure project success.
Procurement and Risk based Design
ASTM Standard E2500-07 outlines the pharmaceutical industry expectation of, “a risk-based and science based approach to the specification, design and verification of manufacturing systems and equipment that have the potential to affect product quality and patient safety” and to “to provide manufacturing capability to support defined and controlled processes that can consistently produce product meeting defined quality requirements”.
E2500-07 requires a risk based approach to process equipment procurement, in line with ICH Guidelines Q8, Q9 and Q10 guidelines and utilising concepts and tools, including Quality Risk Management, SMEs, Good Engineering Practices and equipment vendor involvement.
As you probably already know, Quality by design or QbD is method to ensure the quality of medicines by employing statistical, analytical and risk-management methodology in the design, development and manufacturing of medicines. This is an important benefit you should look for in your pharmaceutical equipment suppliers now, and into the future.
Quality and reliability
The quality of the pharma machines and equipment from your suppliers need to be of a consistent quality. If your supplier falls short on fulfillment such as a late delivery of new plant equipment like a high shear granulator or the setup of cleanroom facilities or defective equipment, this may have severe knock on effects which negatively impact your company in a range of ways.
Avoidable delays of this nature ultimately halts the potential drug from its hopeful final approval date which impacts the treatment of patients who may greatly benefit from its use. Delays, while common in the past in this stage of the buying process will be less of a feature of drug development as standards rise to meet higher standards and processes become more efficient and streamlined.
It’s likely your pharmaceutical company is listed so it will have statutory fiduciary responsibilities to report accurately on the performance of drug development projects to its shareholders. The progress reports can have a significant effect on the share price so there is an added pressure to make the right buyer decision when deciding on which pharma machinery vendor to choose.
Choosing the correct pharma machinery supplier does reflect on the procurement team or key decision makers so choosing carefully is important. Choosing the traditional supplier for say a tablet coating machine your company have always used before may have worked in the past, but in a fast changing pharmaceutical industry this choice may actually deliver poor outcomes if this supplier silo mentality prevents a procurement team from considering other pharma machinery suppliers who are trusted and peer recommended by colleagues in the same space and can deliver better overall outcomes. If nothing else, it gives you leverage when negotiating on service level contracts and other deliverables.
Getting the required quality and reliability from your pharma equipment supplier from the start leads to a better procurement process and supports pharmaceutical drug development success. Pharmacmc.com aims to help subject matter experts and procurement managers identify and justify the best fit equipment and vendors for their manufacturing process in order to best comply with the highest industry standards and expectations.
Speed and flexibility
Pharmaceutical machinery, equipment and excipient suppliers who can deliver on shorter lead times and small batch production capability services give your organisation the edge when iterating in the development stage of the drug development process. This ultimately saves time and money on projects where the pharma market faces a future with less blockbuster drugs to rely upon, so lean business principles will become more commonplace into the future.
A pharma equipment supplier that can meet these growing pharmaceutical industry needs is the right fit for pharmaceutical companies looking to drive new innovation throughout their organisation, particularly in relation to the drug development process.
The simple but powerful advantage of being able to procure frequently, small pharmaceutical machinery, equipment and excipient orders lets you stay in control of budgetary oversight before any capital is unduly allocated on a drug development project. The suppliers list able to adapt to your exacting demands are difficult to curate. With pharma cmc you can leverage the trusted peer recommended pharma machinery and equipment choices of pharmaceutical decision makers just like you.
Multi Region Regulatory Compliance
Regulatory requirements are thankfully modernizing particularly around the unnecessary red tape on outdated procedures which demanded a one size fits all approach to small batch development production accuracy, consistency, efficacy and data specifications and how accurately this can be delivered in full scale drug production environments. Flexible pharma equipment suppliers who respond and adapt to these pharmaceutical industry changes add value to your pharmaceutical company. They help you dynamically respond to fast changing industry demands be they market demand led or regulatory challenges such as the modernization of the FDA and the changes afoot in the EMA in a post Brexit world.
Value for money
Ask any procurement manager and they will tell you, often from bitter experience that value for money does not mean the lowest price but the vendor who can not only meet your drug development project needs in terms of the right specifications be it say a continuous processing solution, but also anticipate future challenges in the project so that servicing contracts or retrofitting existing pharmaceutical plant machinery and equipment is not an issue that will delay a drug development project. If you want reliability and quality from your suppliers, you’ll have to decide how much you’re willing to budget for your machinery, equipment and excipients, and then the balance you want to strike a balance between cost, reliability, quality and service contract fulfillment.
Strong service, clear communication
Building in robust service level agreements helps both you and your pharmaceutical machinery, equipment and excipient suppliers to identify and build in these smart contingencies begins with fostering strong communication channels from the beginning of each drug development project. The lowest price is nearly always not the best value for money. You need your suppliers to be able to deliver on time consistently, and to meet strict regulatory requirements for example on serialisation and data integrity.
Delivering bad news to you fast and early on a project, is far better than late and costly to the project as it means they can discuss how to resolve any potential issues. If this vendor cannot provide a solution on this occasion your project contingencies built into the budget and timeline afford your drug development team to source an alternative supplier without project delay who meet the specified criteria necessary. This means the business relationship is preserved and the original vendor can be a viable option for future project fulfillment which match their fulfillment capabilities according to future exacting project specifications. The best suppliers will want to talk with you regularly to find out what specific needs you have now and how they can deliver for you into the future.
When dealing with the trusted peer recommended list of pharmaceutical machinery, equipment and excipient suppliers on pharmacmc.com the issue of supplier financial capitalization is not really an issue. But the general point is valid and remains an important factor to consider. Making sure your supplier has sufficiently strong cash flow to deliver on orders to the specifications outlined in a SLA. A credit or solvency check is sound financial practice to undertake for any pharma project checklist, taking into account that entire length of the project into your vendor purchasing decision. It will also help to reassure you and other stakeholders that your suppliers are unlikely to go into examinership or worse during the project, potentially delaying multiple key projects. So if you are considering breaking the supplier silo of old, why not explore the pharmaceutical machinery suppliers on pharmacmc.com who are trusted and recommended by pharmaceutical professionals like you.