Supplier Qualification: Sourcing PFS Components as a Challenge for Emerging Biotechnology Companies
In drug development markets across the world, prefillable syringes continue to gain ground as a preferred method of delivery thanks to the many containment benefits offered by these combination devices.
Whether administered by a healthcare professional, a caregiver or a patient, using a prefilled syringe comes with built-in assurances that the stability and integrity of the drug product is protected by sterile containment conditions, and that a precise dose can be delivered with superior accuracy compared with manual preparation from a vial.1 For emerging biotechnology companies in particular, these strengths hold notable appeal in the face of the many challenges associated with the packaging, storage and delivery of delicate and complex biologics.
But while the successful development of a prefilled syringe allows concerns and burdens around delivering an injectable medicine to be eased, this point is only reached after drug companies have navigated their way through the complexities of an arduous and closely controlled development journey that is further complicated by the fact that prefilled syringes are regulated as combination products. Sponsors rising to this challenge are ultimately responsible for selecting, evaluating, qualifying and approving multiple component suppliers to establish the robust, efficient framework necessary for consistent manufacture of high-quality, sterile combination products that comply with the stringent requirements of global regulatory bodies.
However, with no pre-populated template to follow, this supplier selection process is far from straightforward. For each component, multiple phases will need to be undertaken, from initial planning and scoping to qualification and documentation review. These strands must then be harmonised together into a coherent whole. It goes without saying that such a journey is beset with possible pitfalls, and if any missteps are made or problems arise they can result in delays to a drug product's scheduled development as well as additional costs. At the same time, there is the chance of milestones being missed, launch dates being pushed back and onmarket earnings being lost.
Conversely, if the many moving parts of this supplier selection process are carefully considered and controlled, there is an opportunity for risks to be kept to a minimum. In this article we will cover some of the aspects that emerging biotechnology companies should be aware of when it comes to establishing a robust, reliable prefilled syringe supply chain made up of multiple component providers. We also provide guidance on the key areas of regulatory concern, the approaches that can help accelerate development schedules and the factors that can further hinder a process fraught with potential difficulty.
At first glance, the relatively limited number of components that comprise a prefilled syringe - glass/plastic barrel, plungers, needle shield/tip cap - might not appear to present an onerous procurement challenge. However, with different suppliers for each different component, companies will face multiple requirements to fulfil critical quality assurance measures as guided by current Good Manufacturing Practice (cGMP) regulations. These in-depth measures are an essential part of the systematic evaluation of a component supplier's capabilities, manufacturing practices and quality controls, proving compliance with regulations including Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals) and Part 820 (Quality Management System Regulation) of Title 21 of the Code of Federal Regulations in the United States (21 CFR Part 211 & 820) and the GMP guidelines in the European Union (EU GMP).2, 3
Recommendation
Wiesbaden, Germany24/25 March 2026
Trends in Barrier Systems & Robotics
Understandably, emerging biotechnology companies can regard the whole area of component and supplier selection as a seemingly mountainous challenge that stands in the way of bringing their promising molecule to patients via the preferred delivery mechanism of a prefilled syringe. For companies in this position, and particularly those without beneficial prior experience of putting compliant supply chain infrastructure in place, the path forward is beset with difficult yet delicately balanced questions and choices. At every stage, making well-informed decisions about components and supply partners is crucial to optimise development timeframes, maximise resource efficiency, and avoid the unnecessary complexity that can delay time to market.
Unfortunately for biotechnology companies tasked with securing multiple outsourced procurement agreements, there are currently no ways of shortcutting or streamlining the scouting process, which is necessarily time and resource intensive to ensure that manufacturing arrangements are, as per the EU-GMP guidelines, "appropriately defined, agreed and controlled". As a first step, companies will consider their requirements via an initial requirements assessment in order to define the specification for each particular device part. They will then need to explore the market for potential suppliers, with promising candidates progressing to be issued with requests for information (RFI) as part of an evaluation of their production capabilities and to verify their quality and compliance credentials. Risk assessments and supplier qualification checks will also be carried out as part of this comprehensive due diligence process, with sensitive commercial information protected by the prior signing of Confidential Disclosure Agreements (CDAs). In each negotiation, in-house legal teams will need to interface with the supplier's legal teams in order to arrive at a mutual agreement regarding privacy, with particular emphasis on commercial terms, confidentiality clauses and quality aspects. In some cases, agreements will need to be negotiated between multiple stakeholders simultaneously, adding further complexity.
With confidentiality secured, drug companies can embark on closer evaluation of suppliers in light of their capabilities, manufacturing practices and quality controls. The importance of Quality Management Systems, for example, is underlined in the International Council for Harmonisation (ICH) guideline ICH Q10, which provides a model to guide implementation of a pharmaceutical quality system based on International Standards Organisation (ISO) quality concepts and integrating applicable aspects of GMP regulations. Within chapter 2.7, ICH Q10 clarifies that: "The pharmaceutical company is ultimately responsible to ensure processes are in place to assure the control of outsourced activities and quality of purchased materials." This should include an assessment of a supplier's suitability and competence; the need to define responsibilities and communication processes for quality-related activities; ongoing monitoring and review of contractor performance; and oversight of incoming ingredients and materials to verify they are from approved sources via the agreed supply chain.
Recommendation
Wiesbaden, Germany24/25 March 2026
GMP-compliant Clean Rooms and Facilities
Audits are essential to the supplier qualification process, with Chapter 5.29 of the EU-GMP guidelines underscoring their vital role in evaluating potential providers in the supply chain. They are, however, only one type of assessment, and qualification measures should also encompass other relevant documents and records to build a three-dimensional picture of a supplier's credentials. This should include databases detailing where companies might have been subject to government warnings or cited for non-compliance. Having multiple suppliers, this also means auditing multiple suppliers which adds up time and costs.
When assessing and mitigating supplier-related risk in areas such as regulatory compliance, raw material quality or supply continuity, the adoption and application of quality risk management principles is recommended. Furthermore, methodologies such as Failure Mode and Effects Analysis (FMEA) and Hazard Analysis and Critical Control Points (HACCP) can provide valuable, proven approaches for informing detailed supplier evaluations and supporting audit planning - tasks that should also reference the ICH Q9 guidelines highlighting key considerations around legal requirements and prior compliance. And also here the more suppliers are involved the more complex the risk assessment approach becomes.
It is important to remember, however, that healthy supply chains are not solely defined by a procurer/supplier dynamic. Effective, efficient, quality-driven manufacturing frameworks also depend on a constructive sense of partnership, with agreement on shared objectives and standards, particularly in relation to quality. Honest, open communication and proactive collaboration are key enablers in this scenario, allowing the transparent flow of information and insight between parties to support continuous improvement and to ensure any issues are addressed swiftly before they have a chance to escalate.
Ultimately, however, it is sponsors who are responsible for oversight of the device in the eyes of regulators, making it all the more important that they have systems in place for maintaining accurate and up-to-date documentation related to their supplier management activities. This includes a solid quality management system, quality agreements, certifications, and a robust change control process. These systems should consolidate data and records to support transparency, especially during inspections, enabling stakeholders to present evidence of compliance without exposing entire audit details.
Structures should also be in place to track supplier performance on an ongoing basis. Regular monitoring against established quality metrics and key performance indicators (KPIs) will reveal any deviations from agreed levels. Typically done in regular business review meetings, these require time investment from both sites in the case of multiple suppliers. Continuous performance assessments should also be employed as part of regular requalification programs to ensure suppliers continue to meet pre-established benchmarks. Where there are changes within supplier processes or personnel, potential risks should be identified and mitigated through timely addressing and formal assessments, formalized as part of a change management process. Although such approaches require strategic planning and investment in effort, the resulting enhancements to risk management bring greater overall efficiency through reduced auditing demand, which can free resource allocation and trigger cost savings.
Based on the many considerations discussed above, it is clear that the process of selecting, qualifying and managing a supply partner is far from a straightforward. And with prefilled syringes built on a combination of multiple components, it is easy to see how the requirement for repeating this process with multiple suppliers represents a seemingly insurmountable challenge for the pharmaceutical and biotechnology companies who will hold marketing authorisation and, therefore, responsibility for ensuring the quality, safety and performance of each combination product that reaches the hands of patients.
From the very first phases of supplier scouting through to evaluation of capabilities, assessment of risk and ongoing monitoring, a wide variety of variables must all coalesce to provide critical assurance of prefilled syringe quality as guided by the stringent demands of current Good Manufacturing Practice (cGMP) regulations. It is a nuanced and unforgiving context, with high potential for unexpected and unwelcome issues to arise and for projected timings and costs to spiral. For biotechnology companies embarking on this journey, these risks make it all the more important to ensure that chosen suppliers not only have the deep experience and detailed knowledge of combination product development, but also the enabling mindset to simplify the task of bringing such complex technology to market.
About the Author
Dr Bettine Boltres is a recognized thought leader in the industry, fostering scientific exchange between West and the pharmaceutical sector. She serves as an expert for the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and various ISO working groups.
Note:
1 Ceylan G, Topal S, Turgut N, Ozdamar N, Oruc Y, Agin H, Devrim I. Assessment of potential differences between pre-filled and manually prepared syringe use during vascular access device management in a pediatric intensive care unit. J Vasc Access. 2022 Nov;23(6):885-889. doi: 10.1177/11297298211015500. Epub 2021 May 13. PMID: 33983076.
2 eCFR :: 21 CFR Part 211 -- Current Good Manufacturing Practice for Finished Pharmaceuticals
3 Quality Management System Regulation: Final Rule Amending the Quality System Regulation - Frequently Asked Questions | FDA
