Research‑Grade vs. GMP‑Grade: When Each Makes Sense (and When It Doesn’t)

“Research‑grade” and “GMP‑grade” are labels that get used as shorthand for risk. The problem is that they often mean different things to different functions—R&D, Quality, Procurement, EHS, and Regulatory—so teams either over‑control (slow, expensive) or under‑control (rework, compliance risk).

A practical approach is to stop debating the label and instead define fit‑for‑purpose based on:

1. project stage and exposure,

2. must‑have documentation for that stage, and

3. cross‑functional agreement on what “acceptable” means before you buy or make material.

This is particularly important because “GMP” is fundamentally a quality system expectation (not merely a purity claim). For APIs, the global baseline GMP framework is ICH Q7, which describes GMP for manufacturing APIs under an appropriate quality management system. ICH Database
At the same time, suppliers may use “GMP grade” inconsistently as a marketing label, so you should treat it as a starting point for due diligence—not an endpoint. 

Educational use only. This content does not replace your internal procedures, quality system, contracts, or regulatory obligations.

1) Define the project stage and who will handle or be exposed to the material

This is the single most important framing step because it determines both patient risk and organizational risk (data integrity, supply continuity, regulatory impact).

Ask two questions up front

A. What stage are we in?

A simple stage model that most organizations can apply consistently:

• Discovery / route scouting (nonclinical research)

• Process development / scale‑up (non‑GMP development material)

• Nonclinical tox / GLP‑supporting (materials that will support safety packages)

• Clinical manufacturing (Phase 1 → later phases)

• Commercial (post‑approval supply)

Clinical context matters because regulators explicitly expect GMP principles for investigational products while recognizing that procedures may need to be appropriate to the stage of development (i.e., “phase‑appropriate” controls). EU GMP Annex 13 states that investigational medicinal products should be produced per GMP principles and that procedures should be flexible as process knowledge increases and appropriate to development stage. Public Health

B. Who will handle or be exposed?

Define exposure and handling pathways:

• Human exposure (clinical/commercial use; even microdosing or early Phase 1 considerations)

• Animal exposure (tox or pharmacology studies)

• Worker exposure (potency, sensitizers, genotox concerns; containment strategy)

• Environmental exposure (waste streams, solvent hazards)

If humans will be exposed, “research‑grade” should trigger heightened scrutiny immediately. Even for Phase 1 investigational drugs in the U.S., FDA explains that most Phase 1 investigational drugs are exempt from 21 CFR part 211 under 21 CFR 210.2(c), but CGMP under the FD&C Act still applies—i.e., a risk‑based, controlled approach is expected, not an informal one. U.S. Food and Drug Administration

2) List must‑have documents for this stage; add nice‑to‑have items only if they reduce real risk

This is where many teams waste time: they ask for everything they’ve ever seen (audits, certificates, full validations) instead of asking for what actually reduces risk for the current use.

A practical “must‑have” document set by stage

Stage 1: Discovery / early research (nonclinical, no regulated submissions)

Must‑have (high signal, low overhead)

• Supplier identity and material traceability (lot/batch ID)

• SDS (EHS handling)

• Basic CoA or test summary: identity confirmation + indicative assay/purity and known key impurities (even if not compendial)

• Storage/transport requirements

Nice‑to‑have (only if it changes decisions)

• Impurity profile detail if chemistry decisions depend on it (e.g., route selection)

• Change notification commitment if you need repeatable lots for comparability

Stage 2: Nonclinical tox / GLP‑supporting or pivotal enabling work

Must‑have

• Robust CoA with numerical results for key attributes relevant to study interpretation (assay/purity, key impurities, residual solvents, water, etc.)

• Documented manufacturing summary sufficient to explain impurity risks (not necessarily full GMP batch record, but enough to support conclusions)

• Stability/handling information that prevents “study artifacts”

Nice‑to‑have

• Quality agreement language (especially if recurring supply)

• Supplier reliability checks if you intend to rely on their testing for multiple lots

Stage 3: Clinical (investigational) and beyond

Must‑have

• Evidence the API is manufactured under an appropriate GMP quality system (commonly aligned to ICH Q7 for APIs) ICH Database

• CoA that clearly lists tests, acceptance criteria, and results, authorized by Quality (for APIs, this is part of the GMP expectation set) ICH Database

• Change control and notification expectations (so your filings and comparability aren’t surprised)

• Deviation/CAPA interface and release disposition clarity

Regulators explicitly link GMP for investigational manufacturing to protecting subjects and maintaining trial integrity. Health Canada’s Annex 13 guidance states GMP application is intended to ensure trial subjects are not placed at risk and trial results are not affected by inadequate quality from unsatisfactory manufacture, with changes adequately documented and justified. Canada

The “anti‑pattern” to avoid

Do not treat document requests as a proxy for risk management. Requesting “everything” often delays supply without meaningfully improving quality decisions. Instead:

• identify the decisions you need to make with the material (use, quarantine, reject, investigate), and

• request documents that make those decisions more reliable.

3) Align internal stakeholders on what constitutes “fit‑for‑purpose”

The fastest way to create conflict is to let “fit‑for‑purpose” be decided ad hoc, shipment by shipment.

A better approach is a short cross‑functional alignment that ends with an internal standard: “For Stage X, we require Y evidence, and we accept Z risks.”

Who should be in the alignment meeting

• Quality (supplier qualification expectations; intended use controls)

• Analytical/QC (test method suitability; which attributes matter now)

• CMC / Process Chemistry / MSAT (impurity risks, physical form considerations)

• Procurement / Supply Chain (lead time, dual sourcing, contracting levers)

• EHS (handling/containment, hazards, disposal)

• Regulatory/Clinical Ops (if human exposure or filing impact exists)

What the meeting should produce (two outputs)

Output A: One sentence “fit‑for‑purpose statement”

Examples:

• “For discovery work with no human exposure, we accept non‑GMP material provided identity is confirmed and hazards are controlled.”

• “For any material supporting human exposure, we require phase‑appropriate CGMP controls and documented traceability and change management.”

This is consistent with the reality that Phase 1 has risk‑based CGMP expectations in the U.S., even though full 21 CFR 211 compliance is not required for most Phase 1 investigational drugs. U.S. Food and Drug Administration

Output B: A stage-based evidence table (internal, simple)

Fit‑for‑purpose evidence table (copy/paste)

Operational note: Don’t call something “GMP‑grade” internally unless you can point to the quality system evidence that makes that meaningful for your use. Supplier “GMP grade” labels can be inconsistent. ”

4) Record decisions, owners, and due dates

This is where teams prevent repeat debates and create audit ability.

Decision log (copy/paste)

5) File supporting documents with the final record

If you later change the stage (e.g., R&D → tox → clinical), the historical record becomes critical. File what you used to make the decision, not just what the supplier sent.

Final record contents (copy/paste)

• Stage/exposure determination (Step 1)

• Fit‑for‑purpose statement + evidence table (Step 3)

• Supplier CoA and authorization evidence (as applicable to stage) ICH Database

• Any internal testing performed (identity, confirmatory, impurities)

• Change notification terms (if applicable)

• Handling/containment assessment and EHS guidance

• Deviations/investigations related to receipt or use

6) Schedule a follow‑up review to capture lessons learned

This is how you improve the standard and reduce future cycle time.

Follow‑up review agenda (30 minutes)

1. Did material quality match expectations for this stage?

2. Were any attributes missing that would have changed decisions?

3. Did documentation slow receipt unnecessarily? What can be removed next time?

4. Were there supplier surprises (lot variability, undocumented changes)?

5. Actions: update the fit‑for‑purpose table, owners, due dates.

Quick “when it makes sense / when it doesn’t” summary

Research‑grade makes sense when:

• there is no human exposure, and

• decisions are primarily exploratory (route scouting, feasibility), and

• you have basic identity and hazard controls in place.

Research‑grade does not make sense when:

• humans may be exposed, or

• data will underpin regulated safety/quality claims, or

• you need consistent comparability across lots and time.

GMP‑aligned material makes sense when:

• you need traceability, controlled change, and defensible release expectations (especially clinical/commercial), consistent with API GMP frameworks like ICH Q7 ICH Database

• investigational supply must protect subjects and trial integrity (as reflected in Annex 13 guidance approaches) Public Health+1

Checklist

• Define the project stage and who will handle or be exposed to the material.
• List must‑have documents for this stage; add nice‑to‑have items only if they reduce real risk.
• Align internal stakeholders on what constitutes “fit‑for‑purpose.”
• Record decisions, owners, and due dates.
• File supporting documents with the final record.
• Schedule a follow‑up review to capture lessons learned.

Notes:

This checklist is for educational use only and does not replace your internal procedures.