1What GMP is for.
EU GMP defines good manufacturing practice as “that part of Quality Management which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorisation”. It covers both production and quality control.¹ WHO uses nearly the same definition and adds that GMP “is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture”.² In the US, 21 CFR 210.1 calls the CGMP regulations the minimum practice for the methods, facilities and controls used to make a drug, so that it is safe and has the identity, strength, quality and purity it is meant to have.³
FDA explains why this can’t be left to the final test. A patient can’t tell by looking whether a drug is safe or will work, and testing covers only a sample: a manufacturer may test 100 tablets from a batch of 2 million. So quality has to be “built into the design and manufacturing process at every step”.⁴
Lists such as the “10 principles of GMP” or the “5 Ps” don’t come from the regulators’ texts. Those texts set out the principles below, and inspections are based on them.²⁵
2The basic requirements, side by side.
EU GMP Chapter 1.8 lists eleven basic requirements and WHO’s main principles, section 2.1, list ten, in nearly the same words.¹² The US regulations reach the same points through specific sections of Part 211.⁶
| Principle | EU Chapter 1.8 | WHO section 2.1 | Closest 21 CFR 211 section |
|---|---|---|---|
| Processes are clearly defined, reviewed in the light of experience and shown to be capable; critical steps and significant changes are validated | (i), (ii) | (a), (b) | 211.100(a), written production and process control procedures |
| Staff are appropriately qualified and trained, and trained to carry out procedures correctly | (iii), (v) | (c), (e) | 211.25, personnel qualifications |
| Premises, space, equipment, materials, containers, labels, storage and transport are suitable | (iii) | (c) | 211.42 and 211.63, buildings and equipment |
| Instructions and procedures are written clearly and unambiguously for the facility | (iv) | (d) | 211.100(a) |
| Records made during manufacture show every required step was taken and the product was as expected | (vi) | (f) | 211.100(b) and 211.188, batch records |
| Significant deviations are recorded and investigated to find the root cause, with corrective and preventive action | (vii) | (f) | 211.100(b) and 211.192, production record review |
| Records let the complete history of a batch be traced, including distribution | (viii) | (g) | 211.188 and 211.150 |
| Distribution minimises any risk to quality and follows good distribution practice | (ix) | (h) | 211.150, distribution procedures |
| A system can recall any batch from sale or supply | (x) | (i) | 211.150(b) |
| Complaints are examined, causes of quality defects investigated and recurrence prevented | (xi) | (j) | 211.198, complaint files |
3GMP sits inside a quality system.
None of these works alone. EU GMP says reaching the quality objective “is the responsibility of senior management” and needs the commitment of staff at every level, suppliers and distributors. It requires “a comprehensively designed and correctly implemented Pharmaceutical Quality System incorporating Good Manufacturing Practice and Quality Risk Management”.¹ WHO says the same in nearly identical words.² In EU law, Directive (EU) 2017/1572 requires manufacturers to maintain an effective pharmaceutical quality system with senior management taking an active part.⁷
Quality control is the part of GMP that makes sure materials are not released for use, nor products for sale, “until their quality has been judged to be satisfactory”.¹ Quality risk management rests on two principles: risk to quality is evaluated on scientific knowledge and links back to protecting the patient, and the effort and formality of the process match the level of risk.¹ In the US, the quality control unit has the authority to approve or reject components, procedures and drug products.⁶ FDA sums up CGMP as strong quality management systems, quality raw materials, robust operating procedures, detecting and investigating deviations, and reliable testing laboratories.⁴
4The principles leave room for method.
All three regulators set outcomes and leave the means to the manufacturer. FDA says the CGMP requirements “were established to be flexible”, so each manufacturer can decide how best to implement the controls, and the “current” in CGMP means using up-to-date technologies and systems. The regulations are “the minimum requirements”.⁴ The EU guide accepts methods other than those it describes, and doesn’t restrain new, validated concepts or technologies that give at least an equivalent level of quality management.⁵ WHO calls its text “general guides” that may be adapted, provided the equivalence of an alternative approach is validated.²
5How it runs in Seal.
In Seal, pharmaceutical manufacturing connects materials, batch execution, equipment state, testing, quality events, labels and disposition around shared products and batches. Equipment state gates execution: an overdue calibration or a failed cleaning verification prevents normal use. Corrections keep the original value, reason, author and time, and a deviation opens from the step, material, equipment or sample where it occurred.
Quality management keeps the investigation, CAPA and change control connected to that event, and a corrective action can become a control in the workflow. Regulatory and validation explains how requirements, configuration, verification and change control travel with every change.
References
- 1EudraLex Volume 4, Part I, Chapter 1: Pharmaceutical Quality System, Principle and sections 1.8 to 1.13, European Commission, in operation since 31 January 2013. https:/
/ health. ec. europa. eu/ system/ files/ 2016- 11/ vol4- chap1_ 2013- 01_ en_ 0. pdf (read 6 November 2026) - 2WHO good manufacturing practices for pharmaceutical products: main principles, TRS 986 Annex 2, general considerations and sections 1 and 2, World Health Organization, 2014. https:/
/ www. who. int/ publications/ m/ item/ trs986- annex2 (read 6 November 2026) - 321 CFR Part 210, sections 210.1 and 210.2, eCFR, current to 4 November 2026. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- C/ part- 210 (read 6 November 2026) - 4Facts About the Current Good Manufacturing Practice (CGMP), FDA. https:/
/ www. fda. gov/ drugs/ pharmaceutical- quality- resources/ facts- about- current- good- manufacturing- practice- cgmp (read 6 November 2026) - 5EudraLex Volume 4, Introduction, European Commission, 7 February 2011. https:/
/ health. ec. europa. eu/ document/ download/ 4c7b03e0- 4e60- 49d0- ba10- cb3108893ddf_ en?filename=2011_ intro_ en. pdf (read 6 November 2026) - 621 CFR Part 211, Current good manufacturing practice for finished pharmaceuticals, eCFR, current to 4 November 2026. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- C/ part- 211 (read 6 November 2026) - 7Commission Directive (EU) 2017/1572 on the principles and guidelines of good manufacturing practice for medicinal products for human use, Article 6, EUR-Lex, 15 September 2017. https:/
/ eur- lex. europa. eu/ legal- content/ EN/ TXT/ ?uri=CELEX:32017L1572 (read 6 November 2026)
AQuestions and answers
What are the 5 Ps of GMP?
A memory aid used in training, not a list from any regulator. The regulators’ texts cover the same ground in more detail: people, premises and equipment, materials, defined processes and written procedures, records, deviations, distribution, recall and complaints, all within a quality system run by senior management.
Is testing the finished product enough to meet GMP?
No. Testing checks only a sample of each batch, so it can’t show that every unit is right. GMP requires the process, materials, equipment and people to be controlled so that quality is built in at every step.
Who is responsible for GMP in a company?
Senior management has the ultimate responsibility for an effective quality system, but GMP needs the commitment of staff in every department, and of suppliers and distributors. In the US the quality control unit holds the authority to approve or reject products; in the EU a Qualified Person also certifies each batch.
Do the EU, WHO and FDA agree on the principles of GMP?
On the core, yes. The EU and WHO list nearly the same basic requirements in nearly the same words, and the US regulations cover each one in a specific section. They differ in detail and legal form: the US writes binding regulations, the EU sets binding principles in directives and interprets them in a detailed guide, and WHO publishes general guides that national authorities may adapt.
Do GMP principles apply to clinical trial materials?
Yes. EU GMP and WHO both apply GMP from the manufacture of investigational medicinal products through to product discontinuation. In the US, drugs for phase 1 studies are exempt from Part 211, though not from the law’s general CGMP requirement, until the drug is used in phase 2 or 3 or is marketed.