PLANREFERENCE OUTLINE

Combination Product cGMP Compliance Plan

Plan for meeting the cGMPs of a drug–device or biologic–device combination product under 21 CFR Part 4: product kind, primary mode of action and lead centre, the operating-system decision, a compliance matrix for every called-out provision on a drug-cGMP or QMSR base, constituent parts made elsewhere, and the postmarketing safety reports each constituent part triggers.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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HOW TO FILL THIS IN
How to Set Up cGMP for a Combination Product, step by step →
REGULATIONS MAPPED
21 CFR Part 321 CFR Part 421 CFR Part 82021 CFR Part 211
DOCUMENT TYPE
Plan
LAST UPDATED
October 2026
PURPOSE

The plan behind a combination product’s manufacturing compliance. 21 CFR Part 4 lets a manufacturer of a single-entity or co-packaged combination product meet the drug cGMPs and the device QMSR through one operating system: a base, plus the provisions Part 4 names from the other. This plan records the product’s kind and lead centre, the base chosen and why, where each called-out provision is met, and the safety reports each constituent part triggers.

What's Inside

✓Product kind, primary mode of action, lead centre and application type
✓The operating-system decision and its reasoning
✓A compliance matrix for the device provisions on a drug-cGMP base
✓A compliance matrix for the eight drug sections on a QMSR base
✓Constituent parts made at separate sites and the requirements they meet
✓The postmarketing safety reports each constituent part adds

How to Use It

1Record the kind, primary mode of action and lead centre first; seek a designation if they are unclear.
2Choose the base system and complete only the matching called-out table.
3Give every provision a procedure reference and an owner, or write the procedure.
4List constituent parts made elsewhere and confirm their quality agreements.
5Map each safety-report type to the procedure that produces it.
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Product and Jurisdiction
2Operating System Decision
3Called-Out Provisions — Drug cGMP Base
4Called-Out Provisions — QMSR Base
5Constituent Parts Made Elsewhere
6Postmarketing Safety Reporting
AAppendix A — Approval
REGULATORY CONTEXT

21 CFR 3.2(e) defines the kinds of combination product, and 3.4 assigns the lead centre by primary mode of action. 21 CFR 4.3 applies each constituent part’s cGMPs; 4.4(b)(1) names the ISO 13485 clauses and QMSR sections a drug-based system must also meet since 2 February 2026, and 4.4(b)(2) names the drug cGMP sections a QMSR-based system must meet. 4.4(c) and (d) cover separate sites; 4.102 sets postmarketing safety reporting. The plan structure is SPEQ practitioner synthesis.

MAPPED STANDARDS
21 CFR Part 321 CFR Part 421 CFR Part 82021 CFR Part 211
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  1. FILL IT INHow to Set Up cGMP for a Combination Product →The procedure this template records, one step at a time.
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