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GxP, decoded side by side.

The comparisons practitioners actually search — two frameworks, standards, or concepts placed head to head. What each is, where they differ, and when to lean which way.

45 comparisons in library

GAMP 5 vs CSA

Two ways to assure computerized systems — and how they now converge.

ISO 13485:2016 vs FDA QMSR

The device quality-system pair that just became (mostly) one.

US cGMP vs EU GMP

The two GMP regimes a global supply chain has to satisfy at once.

ICH Q9(R1) vs ISO 14971:2019

Two risk-management standards — one for pharma quality, one for device safety.

GLP vs GMP

The two “G”s people mix up — one governs studies, the other governs product.

Verification vs Validation

Built it right, or built the right thing? The distinction inspectors probe.

ISO 9001:2015 vs ISO 13485:2016

The general QMS standard vs the medical-device one built on top of it.

21 CFR Part 11 vs EU GMP Annex 11

The two rulebooks for electronic records and computerised systems.

ICH Q7 vs ICH Q10

API manufacturing rules vs the quality system that governs the whole lifecycle.

IQ / OQ vs PQ

The three qualification stages — installed right, operates right, performs right.

CAPA vs Change Control

Fixing what went wrong vs controlling what you deliberately change.

Deviation vs OOS

A departure from procedure vs a failing test result — handled differently.

EU GMP Annex 1 vs USP <797>

Sterile manufacturing vs sterile compounding — same enemy, different regimes.

EU MDR vs FDA QMSR

The two regimes a device sold on both sides of the Atlantic must clear.

EU MDR vs EU IVDR

The device pair — one for what you put in the body, one for what you test outside it.

503A vs 503B

Two compounding pathways — patient-specific pharmacy vs cGMP outsourcing facility.

Process Validation vs CPV

Proving the process works vs proving it stays working.

US DSCSA vs EU FMD

Two serialization regimes fighting falsified medicines — different models.

ICH Q8(R2) vs ICH Q11

Quality by Design for the drug product vs for the drug substance.

Prospective / Concurrent vs Retrospective

Validate before, during, or after routine production — and when each is allowed.

Design Verification vs Design Validation

Outputs meet inputs, or the device meets the user’s real need?

Category 3 / 4 vs Category 5

How much validation a computerized system needs depends on how custom it is.

ISO 14644-1 vs EU GMP Grade

Two ways to classify cleanroom air — and how they line up.

RABS vs Isolator

Two barrier technologies for aseptic filling — how much they separate people from product.

ICH E6(R2) vs ICH E6(R3)

Good Clinical Practice’s update — from addendum to a principles-led rewrite.

FDA IND vs EU CTR

Two front doors to running a clinical trial — US application vs EU regulation.

IEC 62304 vs FDA Premarket Cybersecurity

Software safety lifecycle vs securing the device against attack.

EU GDP vs WHO GDP

Two Good Distribution Practice frameworks for the medicine supply chain.

USP <795> / <797> vs USP <800>

The three compounding chapters — non-sterile, sterile, and hazardous drugs.

Master Batch Record vs Batch Record

The approved template vs the executed, signed proof of one batch.

ICH Q9(R1) vs ICH Q10

The risk-management method vs the quality system it operates inside.

Quality Agreement vs SLA

Who owns which quality decision vs who delivers what service level.

Supplier Qualification vs Supplier Audit

The whole approval process vs one tool used within it.

Internal Audit vs External Audit

Auditing yourself vs being audited by someone outside.

FDA PV Guidance vs EU GMP Annex 15

The US lifecycle guidance vs the EU qualification-and-validation annex.

ASTM E2500 vs Traditional C&Q

Risk- and science-based verification vs the classic DQ/IQ/OQ/PQ sequence.

HBEL / PDE vs Dose-based / 10 ppm

Toxicology-based cleaning limits vs the old 1/1000-dose and 10-ppm rules.

Moist Heat vs EO / Radiation

Three terminal-sterilization methods — heat, gas, and irradiation.

Bioburden vs Sterility Test

Counting the microbial load before vs proving sterility after.

ICH E2A vs ICH E2D

Safety reporting before approval vs after — clinical trials vs post-marketing.

PSUR vs PBRER

The periodic safety report — and the benefit-risk evolution of it.

ISO 14971 vs FMEA

The risk-management standard vs one analysis tool used within it.

Corrective Action vs Preventive Action

Fix what happened vs stop what could happen — the two halves of CAPA.

Quality Manual vs Quality Policy

The document that describes the system vs the statement of intent behind it.

Form FDA 483 vs Warning Letter

Inspectional observations vs a formal enforcement escalation.

COMPLETE INDEX — ALL 45 COMPARISON