GMP / cGMP – Good Manufacturing Practice and the Expectation of Current Best Control

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

Updated October 2025 • Manufacturing Compliance • Drugs, Biologics, Devices, Food & Supplements

GMP (Good Manufacturing Practice) is the body of requirements that governs the manufacture and quality control of regulated products. The “c” in cGMP emphasizes “current,” signaling that firms are expected to adopt state-of-the-art controls that are appropriate to risk, not merely the minimum described decades ago. Whether applied to human or veterinary drugs and biologics (21 CFR 210/211), medical devices (820), food (117) and dietary supplements (111), or allied global expectations, the practical substance is similar: documented processes; qualified facilities, utilities, and equipment; validated computerized systems; controlled materials and labels; trained personnel; reliable data and records; and formal release by quality authority. The organizing concepts—Document Control, master records, eBMR/eMMR, deviations and CAPA, management review—form a closed loop: define how work shall be done, execute under control, capture the truth contemporaneously, investigate and improve.

“GMP isn’t a checklist to pass inspection; it is a manufacturing dialect where every action, measurement, and decision can be read back as evidence that quality was built in.”

1) Scope of Control Across the Manufacturing Lifecycle

A GMP system spans receipt of materials, storage and picking, production and in-process control, packaging and labeling, testing and release, and distribution. It begins with Goods Receipt, where identity, quantity, status, and expiry/retest are verified and recorded; materials enter quarantine until Component Release. Warehousing applies Bin / Location Management, FIFO/FEFO, and Directed Picking, using GS1/GTIN and application identifiers to capture lot/expiry/serial consistently. Execution is governed by master instructions and specifications—paper BMRs or, ideally, eBMR instances generated from an approved eMMR—with preconditions and acceptance criteria at each step. Testing and sampling plans (AQL, in-process checks, release testing) are documented; labels are controlled under Document Control; and Finished Goods Release occurs only after independent QA review. Distribution expectations (see GDP) carry controls forward into storage and transport so that release conditions remain valid at delivery.

2) People, Premises, and Qualified Equipment

Personnel are qualified and trained for their roles; training is tracked and linked to effective procedures so that critical actions can be gated until competence is proven. Premises and utilities must not compromise product quality; cleaning and changeover controls, environmental conditions (see Environmental Monitoring), and pest and sanitation programs are defined and recorded. Equipment is selected, installed, and maintained in validated state through IQ/OQ/PQ, with ongoing calibration/cleaning/maintenance that blocks use if out of status. Where data originate electronically—balances, PLCs, barcode scanners, label printers—controls at the source remove transcription and backdating risk and support ALCOA+ evidence capture.

3) Masters, Records, and Data Integrity

GMP depends on the integrity of masters and records. Masters—SOPs, specifications, test methods, master production and control records, label templates—are authored, reviewed, approved, issued, revised, and archived under Document Control. Executed records (paper or electronic) must demonstrate that the batch followed the master version in force, with audit trails, timestamps, and meaning-of-signature where electronic per 21 CFR Part 11 and EU Annex 11. Data Integrity (ALCOA+) requires that evidence is attributable to specific users/instruments, contemporaneous with the action, accurate and complete (including raw data and attachments), enduring for the retention period, and available on demand. In modern plants, the eBMR becomes the execution substrate that turns masters into step-gated actions with device data and interlocks, producing an inspection-ready dossier by design rather than by after-the-fact compilation.

4) Process Control, In-Process Checks, and Statistical Vigilance

GMP expects processes to be designed and controlled to yield conforming output consistently. This includes defined process parameters and tolerances, validated methods, qualified ranges, and monitoring regimes. In-process checks—weights and measures (see Batch Weighing), intermediate assays, environmental checks, label template confirmations—are performed at points of greatest risk. Statistical tools and limits (see Control Limits (SPC)) are used to detect drift; Continued Process Verification (CPV) trends process capability over time. Modern cGMP practice favors prevention through error-proofing (barcode validation against reservations, recipe and label interlocks, equipment status checks) rather than relying on inspection to catch defects downstream. Genealogy and traceability (see Batch Genealogy) ensure that inputs and outputs are linked and that affected lots can be identified quickly during investigations or recalls.

5) Deviations, Investigations, Change, and Improvement

When work departs from approved process or specification, GMP demands prompt documentation and containment through Deviation / Nonconformance workflows. Investigations employ structured methods (5-Why, Ishikawa, fault tree) and quantify risk and impact on product quality, safety, and compliance. Dispositions (use-as-is with justification, rework/reprocess under control, reject/scrap, supplier return) follow defined authority chains and may trigger CAPA when systemic causes are identified. Changes to processes, materials, labels, methods, or computer systems are governed by Change Control, with impact assessment on validation status and training. Periodic reviews such as APR/PQR consolidate trends—deviation and override rates, yield, label mismatches, out-of-trend data—and drive management decisions about resources and improvement priorities. The mark of cGMP maturity is not the absence of deviations but the speed and quality of learning and the reduction of recurrence.

6) Labeling and Packaging Controls

Mislabeling is a high-severity failure mode across industries. GMP requires that label content and templates are controlled masters under Document Control, that print/apply is verified by scan-back, and that unused labels are accounted for. Use of GS1/GTIN with application identifiers (lot, expiry, serial) supports machine-checkable packaging and reduces wrong-lot, wrong-label risk at the point of application. For devices, UDI expectations align with unit-level identification and DHR completeness; for food and supplements, allergen and shelf-life declarations interact with Expiry & Shelf-Life Control and FEFO rules to prevent the distribution of out-of-date product. Label reconciliation, line clearance, and tamper-evidence are part of routine controls recorded in the eBMR or associated QC documentation.

7) How This Fits with V5

V5 by SG Systems Global is engineered to make cGMP the default path. In V5 MES, approved eMMR masters generate eBMR instances that enforce sequencing, tolerances, training gating, equipment status checks, and Barcode Validation on materials and labels. Device data (balances, PLCs, counters, printers) are captured contemporaneously with attributable users and timestamps; exceptions auto-open deviations/NCs and route through Approval Workflow. V5 QMS governs Document Control, training assignments, Change Control, investigations, and CAPA. V5 WMS captures lot/expiry/serial at Goods Receipt, enforces Directed Picking with FIFO/FEFO, and prevents use of quarantined or expired materials. QA gains a review-by-exception view alongside genealogy, test data, label scans, and CoA, accelerating release decisions. All transactions carry audit trails and align to Part 11/Annex 11 expectations for electronic records and signatures.

8) FAQ

Q1. What distinguishes “cGMP” from “GMP” in practice?
“cGMP” underscores that firms should apply current scientific and technological controls commensurate with risk—e.g., scan-based verification, electronic records with audit trails, and automated interlocks—rather than relying solely on legacy paper processes.

Q2. Are electronic systems mandatory to comply with cGMP?
No, but when data originate electronically or when electronic records/signatures are used to demonstrate compliance, controls under Part 11/Annex 11 apply. Risk, scale, and complexity usually make executable eBMRs more reliable than hybrid paper models.

Q3. How does GMP interface with supplier quality?
Through qualification, quality agreements, and receipt verification. Supplier CoAs can support release with a documented strategy, but high-risk attributes may require confirmatory testing or skip-lot plans under Component Release procedures.

Q4. What demonstrates adequate process validation and control?
Qualified equipment and utilities (IQ/OQ/PQ), validated processes and methods, evidence of control during execution via in-process checks and SPC, and ongoing CPV with effective responses to trends and deviations.

Q5. Can product be released with open deviations?
Only under defined conditions with risk assessment, containment, supporting data, and QA authorization. High-risk categories (e.g., mislabeling, sterility) generally require full resolution prior to release.

Related Reading
• Foundations & Records: Document Control | Data Integrity | 21 CFR Part 11 | EU Annex 11
• Execution & Monitoring: eMMR | eBMR | Control Limits (SPC) | Continued Process Verification (CPV) | Environmental Monitoring
• Materials, Labels & Release: Goods Receipt | GS1 / GTIN | Expiry & Shelf-Life Control | Finished Goods Release
• Quality System & Improvement: Deviation / NC | CAPA | Change Control | APR/PQR | Batch Genealogy