[ TOPIC EXPLAINERS ]

The cornerstone GxP topics, decoded in depth.

Some topics run through every discipline — data integrity, computerised systems, contamination control, process validation, and risk management. SPEQ decodes each one to reference depth: what it means, why it matters, and the standards that define it.

DATA INTEGRITY

Data Integrity & ALCOA+

ALCOA+, the data lifecycle, and why integrity is the foundation every GxP claim rests on.

5 anchor standardsRead the explainer →
CSV / CSA

Computer System Validation & CSA

GAMP 5, the risk-based lifecycle, Part 11, and the shift from documentation to critical thinking (CSA).

4 anchor standardsRead the explainer →
CONTAMINATION CONTROL

Contamination Control & Annex 1

The Contamination Control Strategy, cleanroom classification, and the 2022 Annex 1 revision.

6 anchor standardsRead the explainer →
PROCESS VALIDATION

Process Validation Lifecycle

The three-stage lifecycle — design, qualification, continued verification — and the science behind it.

5 anchor standardsRead the explainer →
QUALITY RISK MANAGEMENT

Quality Risk Management (ICH Q9)

ICH Q9(R1), the risk-management process, common tools, and the pitfalls the R1 revision targets.

4 anchor standardsRead the explainer →
QUALITY BY DESIGN

Quality by Design & Pharmaceutical Development

Building quality in, not testing it in — the QTPP, CQAs and CPPs, the design space, and the control strategy.

4 anchor standardsRead the explainer →
PHARMACEUTICAL QUALITY SYSTEM

The Pharmaceutical Quality System (ICH Q10)

ICH Q10, the four elements, the two enablers, management responsibility, and the lifecycle model of quality.

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CLEANING VALIDATION

Cleaning Validation

Documented proof that cleaning removes residues below health-based limits — HBEL/PDE, MACO, and the shift from arbitrary limits.

3 anchor standardsRead the explainer →
TECHNOLOGY TRANSFER

Technology Transfer

Moving a validated process between sites without losing control — the sending/receiving-unit model, knowledge transfer, and comparability.

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MEDICAL DEVICE QUALITY

Medical Device Quality System (ISO 13485 / QMSR)

ISO 13485, the FDA QMSR harmonisation with 21 CFR 820, device risk management (ISO 14971), and software (IEC 62304).

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MEDIA FILL / APS

Media Fill & Aseptic Process Simulation

How aseptic process simulation validates that a sterile process keeps product sterile — design, acceptance criteria, and the interventions that decide the result.

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BATCH RECORDS

Master Batch Record (MBR) & Batch Production Records

The approved manufacturing template and the contemporaneous execution record — 21 CFR 211.186/211.188, EU GMP Chapter 4, and the move to electronic batch records.

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HACCP

HACCP & Preventive Controls

The seven principles of Hazard Analysis and Critical Control Points, the Codex framework, ISO 22000, and how FSMA preventive controls extend it.

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RABS / ISOLATORS

RABS & Isolators — Aseptic Barrier Systems

How restricted access barrier systems and isolators separate operators from the sterile core — open vs closed RABS, isolators, and what EU GMP Annex 1 now expects.

3 anchor standardsRead the explainer →
BIOBURDEN

Bioburden & Microbial Control

The viable microbial load a product carries before sterilisation — what it drives, how it is tested (USP <61>/<62>, <1116>), and why limits and trends matter.

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SAMD

Software as a Medical Device (SaMD)

Software that is itself a medical device — the IMDRF definition, IEC 62304 lifecycle, ISO 14971 risk, EU MDR Rule 11, and how AI/ML changes the picture.

5 anchor standardsRead the explainer →