1Where each set of rules comes from.
In the US, the drug CGMP regulations in 21 CFR Parts 210 and 211 contain “the minimum current good manufacturing practice” for making, packing and holding drugs. A drug made without complying with them is adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act, and both the drug and the person responsible are subject to regulatory action.¹ Part 211 covers finished pharmaceuticals; the biologics regulations in Parts 600 to 680 supplement it rather than replace it.² FDA explains how it reads the regulations in guidance, which under 21 CFR 10.115 does “not establish legally enforceable rights or responsibilities”. An alternative approach is acceptable if it meets the statute and regulations.³
In the EU, GMP law for medicines for human use is in directives that each Member State transposes. Directive 2001/83/EC empowers the Commission to set the principles of GMP and to publish detailed guidelines.⁴ Commission Directive (EU) 2017/1572 sets those principles for medicines for human use, covering the quality system, personnel, premises, documentation, production, quality control, outsourcing, complaints and recall, and self-inspection.⁵ The detailed guidelines are EudraLex Volume 4, which manufacturers and inspectors “shall take into account” when interpreting the principles.⁵⁶ EMA puts it plainly: manufacturers “can ensure that they meet all their legal obligations by following the EU GMP guidelines”, and any manufacturer supplying the EU market must comply with EU GMP wherever it is located.⁷
So the US puts its binding detail in regulation and its current thinking in guidance, while the EU sets short binding principles and a long, detailed guide that manufacturers and inspectors both work from.
2The differences that change daily work.
| Topic | FDA, 21 CFR 211 | EU GMP |
|---|---|---|
| Batch release | The quality control unit approves or rejects drug products and reviews and approves production records before a batch is released (211.22, 211.192). | A Qualified Person certifies each batch in a register before sale or supply (Directive 2001/83/EC Article 51, Annex 16). |
| Quality system | A quality control unit with written responsibilities and procedures (211.22). | An effective pharmaceutical quality system with senior management taking part (Directive 2017/1572 Article 6, Chapter 1). |
| Quality risk management | Not mentioned in Part 211. | Part of the quality system, with ICH Q9 reproduced in Part III (Chapter 1.12 and 1.13). |
| Self-inspection | Not required by Part 211. | Repeated self-inspections, with records of them and of corrective action (Directive 2017/1572 Article 14). |
| Annual review | At least annually: a representative number of batches, complaints, recalls, returned or salvaged products and investigations (211.180(e)). | Product quality review of at least 12 listed areas, including starting materials and supply chain traceability, variations, stability, equipment qualification and contracts (Chapter 1.10). |
| Batch record retention | At least 1 year after the batch’s expiry date (211.180(a)). | At least 1 year after expiry or 5 years after QP certification, whichever is longer (Directive 2017/1572 Article 9). |
| Retained samples | At least twice the quantity needed for the required tests, kept 1 year after expiry for most products (211.170). | Finished product kept 1 year after expiry, starting materials at least 2 years after release (Directive 2017/1572 Article 11). |
| Early clinical supplies | Phase 1 investigational drugs are exempt from Part 211, though not from the statute (210.2(c)). | GMP applies from the manufacture of investigational medicinal products onwards (Chapter 1.2). |
Sources for the table: 21 CFR 210 and 211,¹² Directive 2001/83/EC,⁴ Directive (EU) 2017/1572,⁵ EU GMP Chapter 1⁸ and Annex 16.⁹
3Who decides that a batch can be released.
Under Part 211 the decision belongs to the quality control unit as a function: it has “the responsibility and authority to approve or reject” drug products and approves production records before release, and any unexplained discrepancy must be investigated “whether or not the batch has already been distributed”.² Under EU law, a named, legally qualified individual carries personal responsibility for each batch. For imported products, that QP must also ensure each batch was fully tested in a Member State, unless an agreement with the exporting country, such as a mutual recognition agreement, relieves them of it.⁴⁹
4How inspections and their outcomes differ.
FDA inspects manufacturing sites worldwide, for active ingredients and finished products.¹⁰ At the end of an inspection, an investigator who has seen conditions that may violate the Act issues an FDA Form 483. It is not a final agency determination; FDA weighs it with the inspection report and the company’s response before deciding what to do.¹¹ FDA can ask a company to recall, and can seek seizure, an injunction or criminal penalties in court.¹⁰
In the EU, each national competent authority inspects the sites on its territory. Sites outside the EU are inspected by the authority of the Member State where the importer is located, unless an MRA applies.⁷ Within 90 days of an inspection, the authority issues a GMP certificate, where applicable, if the site complies, and enters certificates and non-compliance findings in a public EU database, EudraGMDP.⁴⁷
5Where the mutual recognition agreement fits.
The US–EU MRA sectoral annex for pharmaceutical GMP entered into force on 1 November 2017. It began with medicines for human use and was later extended to veterinary medicines. FDA’s capability determinations apply to routine surveillance inspections. Advanced therapy medicinal products, human blood, plasma, tissues and organs, and veterinary immunologicals are excluded.¹² EMA lists what the EU’s MRAs allow in general, though the scope of each differs: relying on each other’s GMP inspections, waiving batch testing on entry, and sharing information on inspections and quality defects.⁷
The MRA lets each side rely on the other’s inspections. It doesn’t merge the rules: a product for the EU market must meet EU GMP, and a drug for the US market must meet 21 CFR 211.⁷¹
6How it runs in Seal.
In Seal, quality workflows are configured for the product and jurisdiction. In batch release, QA records its disposition and, in the EU, the QP then certifies under Annex 16; manufacturer disposition stays separate from each market’s own gates. The quality management workflows cover deviations, CAPA, change control, documents, training, audits, suppliers, complaints and risk, and an APR or PQR draws on batch, laboratory and quality records for a defined period and population.
Each record keeps its audit history and electronic signatures, with controls to support 21 CFR Part 11 and EU GMP Annex 11, as Regulatory and validation sets out. No software alone makes an operation compliant: your quality system, configuration, procedures and training remain part of the assessment.
References
- 121 CFR Part 210, Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; general, 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) - 221 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) - 321 CFR 10.115, Good guidance practices, eCFR, current to 4 November 2026. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- A/ part- 10/ subpart- B/ section- 10. 115 (read 6 November 2026) - 4Directive 2001/83/EC on the Community code relating to medicinal products for human use, Articles 47, 51 and 111, EUR-Lex, consolidated text of 1 January 2025. https:/
/ eur- lex. europa. eu/ legal- content/ EN/ TXT/ ?uri=CELEX:02001L0083- 20250101 (read 6 November 2026) - 5Commission Directive (EU) 2017/1572 on the principles and guidelines of good manufacturing practice for medicinal products for human use, EUR-Lex, 15 September 2017. https:/
/ eur- lex. europa. eu/ legal- content/ EN/ TXT/ ?uri=CELEX:32017L1572 (read 6 November 2026) - 6EudraLex Volume 4, Good Manufacturing Practice guidelines, European Commission. https:/
/ health. ec. europa. eu/ medicinal- products/ eudralex/ eudralex- volume- 4_ en (read 6 November 2026) - 7Good manufacturing practice, European Medicines Agency. https:/
/ www. ema. europa. eu/ en/ human- regulatory- overview/ research- development/ compliance- research- development/ good- manufacturing- practice (read 6 November 2026) - 8EudraLex Volume 4, Part I, Chapter 1: Pharmaceutical Quality System, 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) - 9EudraLex Volume 4, Annex 16: Certification by a Qualified Person and Batch Release, European Commission, 12 October 2015. https:/
/ health. ec. europa. eu/ system/ files/ 2016- 11/ v4_ an16_ 201510_ en_ 0. pdf (read 6 November 2026) - 10Facts 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) - 11FDA Form 483 Frequently Asked Questions, FDA. https:/
/ www. fda. gov/ inspections- compliance- enforcement- and- criminal- investigations/ inspection- references/ fda- form- 483- frequently- asked- questions (read 6 November 2026) - 12European Union (EU) Mutual Recognition Agreement, FDA. https:/
/ www. fda. gov/ international- programs/ international- arrangements/ european- union- eu- mutual- recognition- agreement (read 6 November 2026)
AQuestions and answers
Is cGMP the same as GMP?
In substance, yes. CGMP is FDA’s name for the good manufacturing practice regulations it enforces, in 21 CFR Parts 210 and 211 for drugs. The “current” means companies must use technologies and systems that are up to date, not only those that were adequate when the rules were written.
Does following FDA cGMP satisfy EU GMP?
Not by itself. The two overlap heavily, but the EU adds a Qualified Person’s certification of each batch, a documented quality risk management approach, repeated self-inspections, a broader product quality review and longer batch record retention. A site supplying both markets designs its quality system to meet both.
Does the US–EU mutual recognition agreement mean one inspection covers both?
It lets FDA and EU authorities rely on each other’s routine surveillance GMP inspections. It does not merge the requirements: a product still has to meet the rules of each market it is sold in. Some products, such as advanced therapies and human blood and plasma, are outside its scope.
Are EudraLex Volume 4 guidelines legally binding?
The binding principles are in Directive 2001/83/EC and Directive (EU) 2017/1572, as transposed into each Member State’s law. Manufacturers and inspectors must take the EudraLex guidelines into account when interpreting those principles, and following them is how a manufacturer shows it meets its legal obligations.
Do both require an annual product review?
Yes. FDA requires records to be evaluated at least annually, covering a representative number of batches, complaints, recalls, returned or salvaged products and investigations. The EU’s product quality review, normally annual, covers more: starting materials and active substance supply chains, marketing authorisation variations, stability trends, equipment qualification and contracts among them.