GMP in one paragraph
Good manufacturing practice (GMP) is the set of minimum requirements that make sure medicines and other regulated products are consistently made and controlled to quality standards. In the US, FDA calls them CGMP: “the ‘C’ in CGMP stands for ‘current,’ requiring companies to use technologies and systems that are up-to-date” (FDA). CGMP “provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.”
The stakes are legal, not just technical. “If a company is not complying with CGMP regulations, any drug it makes is considered ‘adulterated’ under the law,” even if the product is not actually harmful, and FDA can pursue recalls, seizures, injunctions and criminal cases (FDA).
Which GMP rules apply
| Product | Main US rule | International reference |
|---|---|---|
| Finished drugs | 21 CFR Parts 210 and 211 | EU GMP (EudraLex Volume 4), PIC/S GMP |
| Active pharmaceutical ingredients | FD&C Act section 501; ICH Q7 guidance | ICH Q7 |
| Biologics | 21 CFR 600-680 plus Parts 210/211 | EU GMP Part I and annexes |
| Medical devices | 21 CFR 820 (QMSR, ISO 13485-based since February 2, 2026) | ISO 13485 |
| Dietary supplements | 21 CFR 111 | Varies by country |
| Human food | 21 CFR 117 | Codex hygiene principles |
This guide focuses on drug GMP, the most common meaning of the term.
The core GMP principles
- A quality unit with real authority to approve or reject materials, procedures and batches
- Written procedures that are followed, and records that prove it
- Qualified people, trained for the jobs they do
- Suitable facilities and equipment, cleaned, maintained and calibrated
- Validated processes and methods, so results are reliable
- Controlled materials, from receipt and testing to release
- Thorough investigations of deviations, failures and complaints, with corrective action
- Data integrity: complete, accurate, attributable records
What FDA cites most
An analysis of FDA’s fiscal year 2025 Form 483 data counted 2,837 drug citations. The most frequent (GMP Insiders):
| Rank | Citation | Topic | FY2025 observations |
|---|---|---|---|
| 1 | 21 CFR 211.22(d) | Quality unit procedures not in writing or not followed | 243 |
| 2 | 21 CFR 211.192 | Inadequate investigation of discrepancies and failures | 164 |
| 3 | 21 CFR 211.100(a) | Absence of adequate written production procedures | 162 |
| 4 | 21 CFR 211.160(b) | Laboratory controls not scientifically sound | 121 |
| 5 | 21 CFR 211.67(a) | Equipment cleaning and maintenance | 95 |
| 6 | 21 CFR 211.68(b) | Computerized system controls | 87 |
The analysis summarizes the pattern as “a Quality Unit that is not consistently functioning as the governing authority mandated by Part 211,” and notes that procedures often “do not reflect reality.”
What changed in 2025 and 2026
- More surprise inspections abroad. On May 6, 2025, FDA said it “intends to expand its use of unannounced inspections at foreign manufacturing facilities” (Hogan Lovells).
- More warning letters. Reed Smith counted 327 FDA warning letters from July 1 to December 3, 2025, “a 73% increase over the same period in 2024” (Reed Smith). That count covers all FDA warning letters, not only GMP ones.
- A push to make drugs in the US. FDA’s PreCheck program, announced August 7, 2025, offers earlier FDA engagement for new US plants. FDA noted that “only 11% are U.S. manufacturers” among makers of APIs used in FDA-approved products (FDA).
Together, these changes mean more inspections with less notice, and more new US facilities that must be GMP-ready from day one.
GMP readiness checklist
- Quality unit responsibilities written, staffed and exercised
- Procedures match how work is actually done
- Training records current for every GMP role
- Equipment cleaning, maintenance and calibration records complete
- Processes, methods and computerized systems validated
- Deviations and out-of-specification results investigated to root cause
- CAPA effectiveness checked
- Records meet data integrity expectations
- Ready for an unannounced inspection at every site, including suppliers
Check GMP documents against the requirements
Most GMP findings start in documents: procedures that do not match practice, investigations that stop short, records with gaps. AskDona reviews SOPs, batch records and investigation reports against 21 CFR 211, EU GMP or your own procedures, flags gaps and contradictions, and cites the passage behind every finding.
Run a sample GMP document assessment on one SOP or investigation. AskDona shows the evidence; your quality unit decides.
FAQ
What does GMP stand for? Good manufacturing practice. In the US, FDA uses CGMP, current good manufacturing practice.
What is the difference between GMP and cGMP? The “c” means current: companies must use up-to-date technologies and systems (FDA).
Which regulation covers drug GMP in the US? 21 CFR Parts 210 and 211 for finished drugs.
What happens if a company violates GMP? Its drugs are legally adulterated, and FDA can issue warning letters, recalls, seizures, injunctions or import alerts.
What is the most common GMP citation? In FY2025, 21 CFR 211.22(d), quality unit procedures not written or not followed (GMP Insiders).
References
All pages opened and checked by October 14, 2026.
| Source | Type | Date | Used for |
|---|---|---|---|
| FDA: Facts about CGMP | Regulator | Nov 21, 2025 | Definition, adulteration |
| GMP Insiders: FY2025 observations | Trade analysis | Jan 5, 2026 | Drug citation counts |
| Hogan Lovells: Unannounced foreign inspections | Law firm | May 8, 2025 | Inspection policy |
| Reed Smith: FDA inspections in 2025 | Law firm | Dec 4, 2025 | Warning letter increase |
| FDA: PreCheck program | Regulator | Aug 7, 2025 | Onshoring, API statistic |