EDQM CEP – Certificate of Suitability to Ph. Eur. Monographs

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated December 2025 • Pharmacopeias, COA, Supplier Qualification, QMS, QRM • Regulatory Affairs, QA, Procurement, CMC, QP Release

EDQM CEP – Certificate of Suitability is a regulatory document issued by the European Directorate for the Quality of Medicines (EDQM) stating that a given active substance or excipient is suitably controlled by a specific Ph. Eur. monograph. In plain terms, a CEP tells EU regulators and marketing authorisation holders that the API or excipient manufacturer has demonstrated they can consistently meet that monograph—so dossier authors don’t have to resubmit the entire substance control package country by country. CEPs are not magic shields; they don’t remove the need for supplier qualification, QMS oversight or ongoing quality monitoring. They do, however, change where effort is focused: from rebuilding the same CTD Module 3 section repeatedly to making sure your supply chain and quality system actually live up to what the CEP claims.

“A CEP doesn’t replace control of the API. It replaces duplicate paper, so you can focus on controlling the supplier and the process.”

1) What an EDQM CEP Actually Is

An EDQM Certificate of Suitability states that the quality of a substance (usually an API, sometimes an excipient) is suitably controlled by a Ph. Eur. monograph, taking into account impurities, residual solvents, and, where relevant, specific risks such as TSE/BSE. The CEP holder submits a dossier to EDQM; EDQM assesses the manufacturing process, impurity profile and controls and, if satisfied, issues a CEP that can be referenced in marketing authorisation applications. The CEP is not a blanket GMP approval or a guarantee that every batch is compliant; it is an assessment that the described process and controls are capable of delivering material in line with the monograph and additional, CEP-specific requirements.

2) CEPs vs DMFs, ASMFs and Full API Dossiers

Without a CEP, API control can be described via Drug Master Files (DMFs), Active Substance Master Files (ASMFs) or full open/closed parts within the MA dossier. CEPs provide an alternative: rather than each national authority reviewing the same API dossier, EDQM reviews once and issues a certificate that multiple authorities can rely on. For MA holders, this can simplify submissions, variations and lifecycle management. For regulators, it reduces duplication. For the API manufacturer, it concentrates regulatory interactions with EDQM rather than every individual health authority that relies on the CEP. None of these options removes the MA holder’s responsibility for ensuring the API is suitable for their product and process.

3) Types of CEP – Chemical, Herbal, TSE/BSE and Others

Most CEPs relate to chemically defined APIs and their impurity control strategies. However, there are also CEPs that relate specifically to TSE/BSE risk for materials of animal origin and CEPs for some excipients or herbal substances. In each case, the scope of the CEP matters: it defines which risks, impurities and control elements EDQM has actually assessed. For example, a CEP that focuses on TSE risk does not automatically cover all aspects of chemical purity and vice versa. MA holders must understand which aspects of API control are covered by the CEP and which remain their own responsibility to justify and monitor.

4) What EDQM Reviews Before Granting a CEP

To issue a CEP, EDQM assesses the manufacturing process description, control strategy, impurity profile, analytical methods, specifications and how the Ph. Eur. monograph is applied in practice. EDQM wants to see that the monograph and any additional requirements (e.g. for specific impurities) are sufficient to control the substance’s quality throughout its lifecycle. They may request additional tests, tighter limits, or specific controls beyond the baseline monograph. For TSE-related CEPs, EDQM looks at animal species, tissues, country of origin and inactivation steps. The CEP thus reflects EDQM’s current view of what is needed to claim “suitability,” not just a generic statement that the monograph exists.

5) CEP Content – What’s Actually on the Paper

A CEP typically includes the substance name, reference to the specific Ph. Eur. monograph, the holder’s name and site(s), and any additional tests, limits or conditions beyond the monograph. It also identifies the CEP version and validity status. Some CEPs specify solvent classes, impurity limits, or specific test methods that must be used in addition to the monograph. Understanding these conditions is essential when transcribing specs into your own BOMs, testing plans and SOPs. Treat the CEP as a detailed control document, not just a certificate to file away.

6) CEPs and the EU Marketing Authorisation Dossier

In the EU CTD structure, CEPs can be referenced in Module 3 instead of including a full API dossier. The MA holder still has obligations: to ensure the CEP is valid and current, to align their own specifications and controls with the CEP (including additional tests), and to reflect any CEP-driven changes in their variation strategy. Regulatory authorities may still ask questions about how the API behaves in the finished product, the choice of grade, and the appropriateness of controls in relation to the dosage form and process. A CEP simplifies, but doesn’t replace, your CMC story.

7) CEPs, GMP and Inspections – What They Do and Don’t Prove

A CEP is not a GMP certificate. It assumes manufacturing under an acceptable GMP framework but does not replace GMP inspections or GDP/GMP compliance elsewhere in the supply chain. Health authorities and EDQM can and do inspect CEP holders; serious GMP non-compliance can lead to CEP suspension or withdrawal. For the finished-product manufacturer and QP, the CEP is one input into supplier evaluation—not a guarantee that every batch is compliant. You still need supplier audits, verification of COAs, and oversight of transport, storage and distribution practices.

8) CEP Lifecycle – Renewals, Revisions and Withdrawals

CEPs are not static. EDQM can revise CEPs when new information emerges about impurities, processes, or pharmacopoeial requirements. Holders must submit variations for significant changes in manufacturing, controls or sites. CEPs can be suspended or withdrawn if safety concerns arise, serious GMP issues are identified, or the holder fails to keep the CEP in line with reality. MA holders must monitor CEP status and ensure that their dossiers and supply chains are updated accordingly; relying on an outdated CEP version is a classic gap found in inspections and QP audits.

9) The MA Holder’s Responsibilities When Using CEPs

Even with a CEP, the marketing authorisation holder remains responsible for ensuring that the API is suitable for the finished product and that the control strategy is adequate. That means: verifying the CEP’s scope and conditions, aligning internal specifications and test methods, implementing appropriate supplier qualification and auditing, and monitoring variability through trending and PQR/APR. The QP must be comfortable that CEP-based controls, actual supplier performance, and the company’s own QMS are coherent and robust—not just that a certificate is on file.

10) CEPs and Supplier Qualification

CEPs can make supplier qualification more efficient, but they do not replace it. A risk-based approach (see QRM) should consider the criticality of the API, its route of administration, patient population, history of recalls or shortages, and the supplier’s GMP track record. Audits—remote or on site—should verify that the manufacturing process matches the CEP, that changes are communicated appropriately, and that batch documentation, stability programmes and cleaning validation support what the CEP claims. A CEP is a strong starting point, not the destination, for trust.

11) CEPs and Change Control – Don’t Let the Supplier Outpace You

When the CEP holder changes their process, controls or sites, they must update EDQM; but the MA holder must also manage change on their side. That means evaluating the change’s impact on the finished product, determining the need for dossier variations, updating internal documentation and, if appropriate, performing bridging studies or additional testing. Effective change control requires information flow from the supplier (via quality agreements), internal risk assessment, and proactive communication with regulators where necessary. Finding out about a major API process change during an inspection is not a good look.

12) CEPs and Multi-Sourcing Strategies

Many companies qualify multiple CEP holders for the same API to improve supply security. Each CEP may correspond to a different process, impurity profile, and control strategy—even if the monograph is the same. That can impact finished product quality, stability, and process robustness. A multi-source strategy should include comparison of impurity profiles, physical characteristics (e.g. polymorph, particle size), and process performance, and may require source-specific controls or limits. Treat each CEP holder as a distinct technical risk, not as interchangeable “paperwork” just because all have EDQM certificates.

13) CEPs Outside Europe – Global Use and Limitations

Although CEPs are anchored in the European Pharmacopoeia system, many non-European regulators recognise or reference them as supportive evidence of substance control. However, recognition is not automatic or uniform. Some authorities may still request local DMFs/ASMFs, additional data, or local pharmacopoeial alignment. For global products, understanding where CEP reliance is accepted, and where it must be supplemented, is part of regulatory strategy. Assuming a CEP will “solve everything everywhere” leads to surprises during non-EU submissions and inspections.

14) Inspections, Non-Compliance and CEP Suspension

EDQM and national inspectorates may inspect CEP holders. Serious non-compliance, quality defects or pharmacovigilance signals can lead to CEP suspension or withdrawal. When that happens, MA holders relying on the CEP must act: assess batch impact, consider recalls or enhanced testing, evaluate alternative sources, and engage with regulators on risk management. In practice, CEP suspension is a stress test of your supplier management and business continuity plans. If your only plan is “hope it doesn’t happen,” your risk posture is fragile.

15) Making CEPs Work for You – Not Against You

Used intelligently, CEPs free up technical and regulatory resources to focus on product-specific and patient-focused risks instead of duplicating API dossiers. That requires integrating CEPs into your QMS: linking them to supplier files, supplier monitoring, PQR, and risk management. They should feature in internal audits and QP reviews, not just in regulatory filing binders. The more transparently you can show how CEPs, on-the-ground GMP and your own controls align, the more resilient your API strategy becomes.

16) FAQ

Q1. Does having a CEP mean we no longer need an API DMF or ASMF?
Often, yes for EU submissions—the CEP can replace a full API dossier in the MA provided its scope is adequate. However, some authorities or specific products may still require additional information, so regulatory strategy must be confirmed case by case.

Q2. Is a CEP the same as a GMP certificate?
No. A CEP is about substance quality and pharmacopoeial control, not GMP certification. GMP compliance is assessed through inspections and separate certificates; serious GMP issues can lead to CEP suspension but the documents serve different purposes.

Q3. If a supplier’s CEP is withdrawn, can we keep using their API?
Not without a careful, documented risk assessment and usually not for long. CEP withdrawal is a major signal to regulators and QPs; it typically triggers increased testing, alternative sourcing, or product changes, and may require regulatory variations or notifications.

Q4. Do we need to audit an API supplier if they hold a CEP?
Yes. A CEP reduces dossier burden but does not replace supplier qualification, audits, and ongoing performance monitoring. Your QMS must still confirm that the supplier operates as described and that material delivered meets your specifications.

Q5. What is a practical first step for using CEPs more effectively?
Create a simple CEP register linked to each product and supplier, including CEP scope, version, additional tests, and status. Integrate this register into supplier qualification, change control, and QP release so that CEPs become active tools in decision-making rather than static attachments.

Related Reading
• API & Supplier Control: Supplier Qualification | Supplier COA Verification | Certificate of Analysis (COA)
• QMS & Risk: Quality Management System (QMS) | Quality Risk Management (QRM) | PQR/APR | Change Control
• Technical Controls: Stability Studies | Cleaning Validation | Test Method Validation (TMV)
• Regulatory Framework: USP & Pharmacopeias | 21 CFR 211 | PIC/S PE009