USP <87>/<88> 修订将于 2026 年 12 月 1 日生效，业内分析一次性使用系统供应链的资质准备

By Matthias Gerlach, Ph.D., independent executive advisor in pharma and biotech

For years, USP Class VI has been a familiar reference in the qualification of single-use components. The latest revisions to USP general chapters <87> and <88> change that framework and raise practical questions for manufacturers relying on supplier qualification data. The immediate concern is whether the evidence supporting a critical component remains sufficient when a material or supplier changes.

The revisions to United States Pharmacopeia (USP) general chapters <87> and <88>,to become effective Dec. 1, 2026, bring this issue into sharper focus. They update biological reactivity testing and change the familiar Class VI framework. For manufacturers relying on single-use systems (SUS), this is a reason to examine what supplier certificates establish, what they leave unanswered, and how those gaps affect manufacturing decisions.

Imagine a hypothetical scene: A shipment of single-use bags has arrived on time for the next manufacturing campaign. Then the team learns that the supplier has changed an additive in the film, and now quality and technical operations must establish whether the existing qualification covers the material now being supplied. That assessment could take longer than the remaining inventory allows.

Bags, tubing, filters, and preassembled flow paths have made biopharmaceutical manufacturing more flexible. They have also moved important material and process decisions beyond the factory gate. When a supplier changes a formulation or a production site, the manufacturer may need information that was never part of the original purchasing discussion.

Having worked with external manufacturers through technology transfer, validation, and commercial supply, I pay particular attention to the gap between receiving a change notification and reaching a decision. The technical assessment matters, of course. So does knowing who has the data, who understands the product, and who can authorize the next step.

What December 2026 Changes — And What It Does Not

USP <87> deals with biological reactivity testing in vitro, while <88> addresses in vivo testing. The revisions update the in vitro testing approach and remove the familiar Class I to VI framework in <88>. Separately, USP <1031> provides related guidance on biocompatibility assessment. Those are meaningful changes, but they should not be read as a universal instruction to retest every single-use component.

Class VI has been a convenient reference in supplier files for many years. It is less useful as a stand-alone answer to a product-specific question. The chemistry of a material, its contact with the process stream, and the conditions under which it is used remain critical inputs. USP <665> and <1665> address chemical characterization and extractables-related risk for manufacturing process-contact plastics; their scope needs to be considered separately from the biological reactivity chapters.

BioPhorum has also discussed the implications of the revisions for SUS and the need for proportionate, use-specific assessment. Existing data do not become worthless simply because a chapter changes. What matters is whether those data remain relevant to the material and its intended application.

The Questions That Matter In Manufacturing

When a critical component changes, the discussion usually comes down to three things: what we know about the material, whether the assembly still works in the process, and how long it will take to reach an approved decision. The same supplier change can look manageable from one perspective and urgent from another.

What Actually Changed?

Take the bag in our example. Its qualification may rest on supplier studies, extractables information, and experience in a defined manufacturing process. A change to the film additive or the manufacturing site does not necessarily mean the bag is unsuitable. It does mean someone must determine whether the evidence on file still describes what is being delivered. The part number alone cannot answer that question.

Before requesting additional testing, I would first ask the supplier three specific questions:

• Which product-contact layers are affected?
• What has changed in the formulation or process?
• Do the available studies reflect our contact times, temperatures, fluids, and manufacturing steps?

In some cases, a documented assessment of existing data will settle the matter. In others, further testing will be needed. Ordering a broad package of tests before understanding the change can waste valuable weeks.

A Qualified Material Is Not Yet A Qualified Assembly

Consider a sterilizing-grade filter. Changing its membrane chemistry may alter protein or excipient adsorption, extractables, wettability, flow, bacterial retention, integrity-test behavior, or sterilization compatibility. The supplier may have sound material data and still be unable to tell us whether the replacement will behave as required in our filling process. That judgment needs process knowledge and, where justified, additional studies.

EU GMP Annex 1 adds an important practical dimension for sterile manufacturing. Sections 8.131 to 8.139 address SUS risks, including product-contact interactions, sterilization, integrity, supplier controls, assembly design, and handling. The position of a filter and the number of aseptic connections can affect the contamination control strategy. Pre-use post-sterilization integrity testing (PUPSIT) is a useful illustration: the assembly must allow the required integrity-testing approach to be carried out reliably in the actual process. These Annex 1 expectations apply independently of the USP revisions.

Who Can Make The Decision In Time?

The third question — how long it will take to reach an approved decision — is often the one that determines whether the next campaign goes ahead. A change notice is only the beginning. The manufacturer needs enough information to assess the impact: a meaningful description of the change, relevant biological and extractables data, and sterilization information where appropriate. Suppliers cannot always disclose complete formulations, but confidentiality arrangements or independent technical review can help close that gap.

When a CDMO buys the assembly, responsibilities must be settled in advance. The supplier may notify the CDMO, while the sponsor holds the product knowledge and regulatory commitments. Who forwards the notice? Who assesses product impact? At what point is the sponsor involved? And who signs off on continued use? I have seen how easily time is lost at such interfaces, even when everyone believes the change-control process is clear.

Return once more to the bag. If inventory covers only a few campaigns, the time needed for assessment becomes a supply constraint. Procurement may have identified another bag supplier, but comparable dimensions and a quote do not establish process suitability. Material data, validation needs, equipment fit, and the change-control path all must be addressed.

Avoiding The Wrong Response

A blanket retesting exercise would miss the point. A short-contact connector and a long-contact storage bag may require different levels of assessment. Historical evidence can remain useful when it is relevant and scientifically justified. The December revisions should prompt a review of critical qualifications, not an indiscriminate request for new certificates.

There are limits to what suppliers can share and what a manufacturing site can implement quickly. A replacement filter or assembly may require changes to operating parameters, operator training, validation, or regulatory commitments. Suppliers may also make material substitutions for reasons unrelated to USP, including environmental or portfolio decisions involving fluorinated polymers. Such developments are not a blanket prohibition on those materials, but they can create qualification work downstream.

The sensible response is to agree in advance which changes require escalation, what evidence the supplier must make available, and how quickly the assessment can realistically be completed. Those arrangements are most valuable when they have been tested before a shortage or an urgent production decision.

Readiness Starts Before The Change Notice

I would begin with a short list of components that are difficult to replace: long-contact bags, specialized filters, custom tubing sets, and assemblies with limited interchangeability. For each one, the manufacturing site and its CDMO, where applicable, should inventory available qualification evidence, itemize what is missing, and map out how a supplier change would be handled.

The review should involve quality, manufacturing, technical operations, and procurement. A few practical questions are enough to expose the gaps.

• Does our justification go beyond a Class VI statement?
• Can we obtain the material and process-relevant data we need?
• Who decides when a supplier changes something?
• How many weeks would it take to introduce the proposed second source, including validation and approval?

Dec. 1 is a useful prompt for those conversations, but it is not a universal retesting deadline. Qualification lead times, supplier access, and decision routes are difficult to fix once the next manufacturing campaign is already at risk.

A component can be available for purchase and still be unavailable for use. That distinction is familiar to anyone who has had to keep a manufacturing schedule moving while a technical assessment remains open. It is also where I believe the USP update has its most useful supply-chain lesson.

References:

1. USP–NF, General Chapters <87> and <88> (consult the current official text and effective-date notices): https://online.uspnf.com/
2. USP–NF, General Chapter <1031> The Biocompatibility of Materials Used in Drug Containers, Medical Devices, and Implants: https://online.uspnf.com/
3. USP–NF, General Chapter <665> (official USP preview; informational status): https://doi.usp.org/USPNF/USPNF_M11135_02_01.html
4. European Commission, EudraLex Volume 4, Annex 1, Manufacture of Sterile Medicinal Products (2022), especially sections 8.131–8.139: https://health.ec.europa.eu/document/download/e05af55b-38e9-42bf-8495-194bbf0b9262_en
5. BioPhorum, Industry response to USP <87>/<88> updates: Implications for single-use systems (2026): https://www.biophorum.com/download/industry-response-to-usp-87-88-updates-implications-for-single-use-systems/

About the Author:

Matthias Gerlach, Ph.D., is an independent executive advisor with more than 25 years of experience in the pharmaceutical and biotech industry. His work spans drug discovery, CMC (chemistry, manufacturing, and controls), pharmaceutical development, technology transfer, external manufacturing, global supply chain, and commercialization. He most recently served as managing director and SVP of manufacturing and supply chain at Aeterna Zentaris GmbH in Germany. He has worked with international CROs and CDMOs across development and commercial manufacturing and currently advises biotech companies and industry partners on CMC, manufacturing, supplier strategy, and operational execution.