What is the difference between GMP and cGMP?

1What the “c” in cGMP means.

CGMP, as FDA writes it, “refers to the Current Good Manufacturing Practice regulations enforced by the FDA”. FDA says the requirements were made flexible so that each manufacturer decides how best to implement the controls, “using scientifically sound design, processing methods, and testing procedures”. Accordingly, “the ‘C’ in CGMP stands for ‘current,’ requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations.” Equipment that was “top-of-the-line” 10 or 20 years ago, FDA adds, “may be less than adequate by today’s standards”.¹

FDA also describes the CGMP regulations for drugs as “the minimum requirements”.¹ Part 210 says the same: the CGMP regulations contain “the minimum current good manufacturing practice” for the methods, facilities and controls used to make, process, pack or hold a drug.²

2Where each term comes from.

The words differ because the legal texts differ.

In the US, the Act deems a drug adulterated if the methods, facilities or controls used for its manufacture, processing, packing or holding do not conform to “current good manufacturing practice”. Since 2012 the Act has said that CGMP includes “the implementation of oversight and controls over the manufacture of drugs to ensure quality”, including managing the risk of, and establishing the safety of, raw materials, materials used in manufacturing and finished drug products.³ FDA’s regulations fill this in: Part 211 for finished pharmaceuticals, Part 212 for positron emission tomography drugs and Part 213 for medical gases.⁴⁵⁶ Device CGMP requirements are set out in the Quality Management System Regulation, 21 CFR Part 820.⁷

In the EU, Directive (EU) 2017/1572 defines GMP as “the part of the quality assurance which ensures that medicinal products are consistently produced, imported and controlled in accordance with the quality standards appropriate to their intended use”. Article 5(2) obliges each manufacturer “to regularly review his manufacturing methods in light of scientific and technical progress”, which is the EU’s version of being current. Manufacturers and competent authorities must take account of the detailed GMP guidelines when interpreting it.⁸ The Commission publishes them in EudraLex Volume 4.⁹

The WHO defines GMP as “that part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the marketing authorization”. Under it, manufacturing processes are “systematically reviewed for associated risks in the light of scientific knowledge and experience”.¹⁰ WHO says the guide is a standard to justify GMP status within its certification scheme for medicines in international commerce, and a basis for inspecting manufacturing facilities.¹¹

3What is the same, and what differs.

The aim is the same in each text: products made consistently and controlled to the quality their intended use requires. The expectation to keep methods current is in all three, in different words. So when a US document says cGMP and a European one says GMP, they are naming the same discipline.

What differs is the detail of the rules, because each comes from a different legal system. Two examples:

• Who releases the batch. In the US, the quality control unit has the responsibility and authority to approve or reject drug products.⁴ In the EU, a qualified person under Article 48 of Directive 2001/83/EC is responsible for certifying each batch, and a contract for outsourced work must say how that person discharges their responsibilities.⁸
• Retained samples. Both keep a sample of each batch of finished product for at least a year after its expiry, in most cases. For materials, the US rule covers each lot of each active ingredient, kept until a year after the last product lot made with it expires. The EU rule covers starting materials other than solvents, gases or water, kept for at least two years after the product’s release.⁴⁸

The page on EU GMP and FDA cGMP compares the two in more depth.

4How compliance is judged.

In both systems, compliance is checked by inspection. FDA inspects pharmaceutical manufacturing facilities worldwide, including those making active ingredients and finished products.¹ In the EU, Member States use repeated inspections to make sure authorised manufacturers respect the principles and guidelines of GMP.⁸

In the US, a drug made without CGMP is adulterated, and the person responsible for the failure is subject to regulatory action.² FDA notes that adulteration in this sense “does not mean that there is necessarily something wrong with the drug”. It can still lead to a recall, a seizure, an injunction or a criminal case.¹

5How it runs in Seal.

The pharmaceutical manufacturing blueprint connects materials, batch execution, equipment state, QC testing, deviations, labels and disposition around shared products and batches, so review begins while the batch runs and release draws on evidence already connected. In the QMS blueprint, a finding, its evidence and the response sit on the same record as the work, and a corrective action can be released as a change to the workflow itself.

Keeping a process current means changing it without losing control. In Seal each change runs its tests and your team releases the version that passes, while earlier work keeps its version. Regulatory and validation explains how that fits GAMP 5, Part 11 and Annex 11.