1The difference in one table.
ICH Q7, the GMP guide for active pharmaceutical ingredients, gives the shortest definitions. Quality assurance is “the sum total of the organised arrangements made with the object of ensuring that all APIs are of the quality required for their intended use and that quality systems are maintained”. Quality control is “checking or testing that specifications are met”.¹ FDA’s 2006 guidance on quality systems describes how industry usually splits the work.²
| Quality control | Quality assurance | |
|---|---|---|
| ICH Q7 definition | Checking or testing that specifications are met | The organised arrangements that ensure quality and maintain the quality systems |
| FDA glossary | “The steps taken during the generation of a product or service to ensure that it meets requirements and that the product or service is reproducible” | “Proactive and retrospective activities that provide confidence that requirements are fulfilled” |
| Typical work, per FDA | Assessing incoming materials, in-process materials and finished products; evaluating process performance against specifications and limits; determining the acceptability of each batch for release | Reviewing and approving procedures for production and maintenance; reviewing the associated records; auditing and trend analysis |
| Looks at | The product and its test results | The system that produces and controls the product |
The table rows come from ICH Q7 and FDA’s guidance.¹²
2What US law requires.
The drug CGMP regulations in Part 211 never use the term quality assurance.³ They require one “quality control unit”, defined as “any person or organizational element designated by the firm to be responsible for the duties relating to quality control” (21 CFR 210.3(b)(15)).⁴ Under 21 CFR 211.22 that unit has the authority to approve or reject components, containers, closures, in-process materials, labelling and drug products, to review production records and make sure errors are “fully investigated”, and to approve or reject every procedure or specification affecting identity, strength, quality and purity. It must have adequate laboratories, and its responsibilities and procedures must be written and followed.⁵
FDA says current practice “generally divides the responsibilities of the quality control unit (QCU), as defined in the CGMP regulations, between quality control (QC) and quality assurance (QA) functions”, and uses the term quality unit for both.² The quality unit does not replace “the daily responsibility of manufacturing personnel to build quality into the product”. FDA normally expects development, manufacturing and the quality unit to remain independent. Where one person must do both production and quality work, another qualified person not involved in production should periodically review the quality unit’s activities.²
3How EU GMP divides them.
EU GMP uses broader terms. Quality management is “the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use”; GMP is part of it, “concerned with both production and quality control”.⁶ Chapter 1 notes that the GMP directives require “an effective pharmaceutical quality assurance system”, and treats that term and pharmaceutical quality system as interchangeable.⁶
Quality control is “that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing”, and with the release procedures that keep materials and products from use or sale until their quality is judged satisfactory.⁶ Chapter 6 adds that QC “is not confined to laboratory operations, but must be involved in all decisions which may concern the quality of the product”, and that its independence from production “is considered fundamental”.⁷
Chapter 2 makes the heads of Production and Quality Control key personnel who “must be independent from each other”. A separate head of quality assurance or of the quality unit may be appointed, depending on the company’s size, sharing some of their responsibilities.⁸ Batch certification sits with a third role: the Qualified Person must ensure each batch was made and checked in line with the law and the marketing authorisation.⁸
4Why both report to quality, not production.
ICH Q7 asks for a quality unit “independent of production” that fulfils both QA and QC responsibilities, “in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization”.¹ Its list of responsibilities that must not be delegated mixes the two: releasing or rejecting APIs, reviewing batch and laboratory records, making sure critical deviations are investigated, approving specifications and procedures, making sure internal audits happen, approving changes and validation reports, making sure materials are tested and results reported, and performing product quality reviews.¹
Independence does not make quality the quality unit’s job alone. ICH Q7 starts from the principle that “Quality should be the responsibility of all persons involved in manufacturing.”¹ FDA says the quality unit should not take on the responsibilities of manufacturing, engineering or development, and that manufacturing personnel and the quality unit “are both critical” to producing quality products.²
5How it runs in Seal.
In Seal, QC and QA work on the same records. The QC blueprint gives analysts the method, instrument data and review requirements in one workflow: instrument data keeps its source, results are checked against the applicable specification version, and the approved decision returns to the batch. An OOS investigation opens with the analytical context already linked, and the CoA is rendered from the release dataset rather than retyped.
On the QA side, the quality management system covers deviations, CAPA, change control, documents, training, audits, suppliers, complaints and risk. For batch release, Neil, Seal’s AI agent, reads each lot’s record, lab results, line log and messages and leaves QA a short list of what needs a person. QA disposes and the QP certifies; Neil never releases a lot or changes the record.
References
- 1ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, sections 2.1 and 2.2 and glossary, ICH, 10 November 2000. https:/
/ database. ich. org/ sites/ default/ files/ Q7%20Guideline. pdf (read 6 November 2026) - 2Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations, section F and glossary, FDA, September 2006. https:/
/ www. fda. gov/ media/ 71023/ download (read 6 November 2026) - 321 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- C/ part- 211 (read 6 November 2026) - 421 CFR 210.3, Definitions, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ section- 210. 3 (read 6 November 2026) - 521 CFR 211.22, Responsibilities of quality control unit, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ section- 211. 22 (read 6 November 2026) - 6EudraLex Volume 4, Part I, Chapter 1: Pharmaceutical Quality System, European Commission, in operation from 31 January 2013. https:/
/ health. ec. europa. eu/ system/ files/ 2016- 11/ vol4- chap1_ 2013- 01_ en_ 0. pdf (read 6 November 2026) - 7EudraLex Volume 4, Part I, Chapter 6: Quality Control, European Commission, in operation from 1 October 2014. https:/
/ health. ec. europa. eu/ document/ download/ c74c8720- 27bf- 4252- 808f- d65a206a90bb_ en?filename=2014- 11_ vol4_ chapter_ 6. pdf (read 6 November 2026) - 8EudraLex Volume 4, Part I, Chapter 2: Personnel, European Commission, in operation from 16 February 2014. https:/
/ health. ec. europa. eu/ document/ download/ 11f4f8e6- a6e9- 4897- afe3- f21e1dc56cb8_ en?filename=2014- 03_ chapter_ 2. pdf (read 6 November 2026)
AQuestions and answers
Is QC part of QA?
In the EU model, QC sits inside the quality system. Quality management is the whole system, GMP is part of it, and GMP covers both production and quality control. In practice QA and QC are usually separate teams with different duties, both within the independent quality function.
Who releases a batch, QA, QC or the Qualified Person?
It depends on the jurisdiction. In the US the quality control unit approves or rejects drug products, and companies divide that work between QC testing and QA review. In the EU, QC judges whether quality is satisfactory, and a Qualified Person certifies each batch before it can be sold or supplied. For APIs under ICH Q7, the independent quality unit releases or rejects.
What is a quality unit?
The term ICH Q7 and FDA use for the part of the organisation, independent of production, that carries both QA and QC responsibilities. It can be separate QA and QC departments, one combined group, or in a small company one person, as long as its responsibilities are written down and not delegated.
Can one person do both QA and QC in a small company?
Yes. ICH Q7 allows the quality unit to be a single individual depending on the organisation’s size. FDA goes further in very limited circumstances, allowing one person to do production and quality work, but recommends that another qualified person not involved in production periodically reviews the quality activities.
Does QA review laboratory records?
Usually, as part of reviewing records before release. US rules require a second person to review laboratory records for accuracy, completeness and compliance, and the quality unit to review production and control records before a batch is released. Which team performs each review is the company’s decision, written into its procedures.