What Is GMP? Quality and Compliance in Practice
Understand GMP regulations and their importance for quality, compliance, and patient safety.
What is GMP?
GMP stands for Good Manufacturing Practice, or 'god fremstillingspraksis' in Danish, and if you work in production, QA, or warehousing in a GMP-regulated company, these are your daily rules of the game.
GMP (Good Manufacturing Practice) is a set of international rules and guidelines that establish requirements for the manufacture, control, documentation, and release of medicinal products. The purpose is to ensure that products are safe, effective, and of consistent quality—batch after batch.
It's all about creating good habits, robust processes, and employees who understand why the rules exist.
On this page, you'll find answers to:
- What is GMP?
- Who sets the GMP requirements?
- What are the key principles of GMP?
- What does GMP require of me as an employee?
- What are the typical GMP violations in practice?
- What do the authorities require—and what happens if you violate the rules?
- How can you ensure that products are clean and prevent contamination?
- What are the guidelines for collaborating with external partners?
- GMP Checklist
Regarding GMP:
- Manufacture and Control of Medicines for Human Use
- Veterinary Medicines
- Active Pharmaceutical Ingredients (APIs)
- Medical Devices (MDR/IVDR)
In the EU, GMP is primarily regulated by EudraLex Volume 4, which contains the fundamental principles (Part I and Part II) and a wide range of technical attachments (Annexes) on specific requirements.
Watch the video on the right for a brief explanation of GMP.
Who sets the GMP requirements?
In the EU, GMP requirements are established by the European Commission through EudraLex Volume 4 and enforced at the national level—in Denmark, by the Danish Medicines Agency. Violations may result in warnings, production halts, product recalls, and, in serious cases, the revocation of the manufacturing license.
What are the consequences of GMP violations?
The consequences of GMP violations depend on their severity:
- Observation / minor finding — written comment; expected to be corrected by the next inspection
- Major finding — a written action plan is required, typically within 30 days
- Critical finding — production may be halted and/or a recall may be initiated with immediate effect
- Repeated violations — may result in the revocation of a production license
Authority / Document |
Scope of Application |
| EudraLex, Vol. 4 | EU GMP Requirements for Human Medicines |
| FDA 21 CFR Parts 210/211 | U.S. GMP Requirements (cGMP) |
| ICH Q10 | International Quality System for Pharmaceutical Manufacturing |
| Danish Medicines Agency (DK) | Danish GMP Oversight, Inspections, and Manufacturing Licenses |
| WHO GMP | GMP Requirements for Global Pharmaceutical Manufacturing |
What are the key principles of GMP?
GMP is based on six fundamental principles: written procedures, trained personnel, validated processes, controlled raw materials, traceable documentation, and independent quality control. Together, these ensure that products are manufactured as specified—and that errors can be detected and corrected.
- Written procedures (SOPs)—all actions are described and approved in advance
- Trained staff — employees must understand and follow the procedures
- Validated processes and equipment — documented proof that it works
- Verified Raw Materials and Suppliers — Only Approved Materials and Suppliers
- Traceable documentation — everything that is done is recorded and can be verified
- Independent QA function — quality is checked separately from production
What does GMP require of me as an employee?
As an employee of a GMP-regulated company, you must be familiar with and follow the procedures that apply to your role, document your actions accurately and in real time, and report deviations and errors—even when it’s uncomfortable to do so.
- Follow only approved procedures (SOPs)—do not improvise
- Document everything you do — “if it’s not written down, it didn’t happen”
- Never edit documentation without ensuring traceability
- Report discrepancies—even those that seem insignificant
- Stay up to date on changes to procedures and requirements
What are the typical GMP violations in practice?
The most common GMP violations involve missing or delayed documentation, unreported deviations, and changes implemented without change control.
- Missing or delayed documentation — “I’ll write it up later”
- Deviations are ignored or resolved informally without reporting
- Changes to processes or equipment without change control
- Outdated or invalid procedures are still being used
- Training is not documented — “everyone knows how to do it”
EXAMPLE:
An employee notices an incorrect weight measurement, corrects it, and “forgets” to record the correction. Production continues. Afterward, it is impossible to document that everything is correct—and the batch may have to be recalled. GMP documentation is not about bureaucracy, but about traceability and patient safety.
How do you ensure that your products are clean and prevent contamination?
Preventing contamination is a core requirement of GMP. It involves ensuring that products are not contaminated by foreign substances, microorganisms, or other products—whether during manufacturing, storage, or transport. The requirements are described in EudraLex, Vol. 4, Chapters 3 and 5.
Practical Requirements for Employees in Production Areas
- Wear the appropriate personal protective equipment (PPE) and work clothes for the area
- Follow hygiene procedures—hand hygiene, cleaning, and behavior in cleanrooms
- Report any visible signs of contamination or irregularities immediately
- Avoid unnecessary movement and traffic in controlled production areas
Contamination can originate from three sources
| Type | Example | Prevention |
| Physical contamination | Glass shards, metal particles, foreign objects | Filtration, detection systems, inspections |
| Chemical contamination | Cleaning product residues, cross-contamination | Cleaning validation, dedicated equipment |
| Microbiological contamination? | Bacteria, mold, yeast | Cleanrooms, environmental monitoring, sterilization |
What are the guidelines for collaborating with external partners?
When a GMP-regulated company outsources manufacturing, testing, or other GMP activities to an external partner (CMO, CRO, or supplier), responsibility for GMP compliance is not transferred.
The ordering company remains responsible and must ensure that the partner complies with GMP requirements. The requirements are described in EudraLex, Vol. 4, Chapter 7.
Requirements for Managing External Partners
- A written quality agreement (Quality Agreement / Technical Agreement) must be entered into before the collaboration begins
- The supplier must be audited and approved—and re-audited on a regular basis
- All activities and responsibilities must be clearly defined and documented
- Changes made by the partner must be communicated and evaluated through change control
Examples of external partners
- Raw material suppliers and packaging suppliers — require supplier qualification
- Contract laboratories (QC testing) — require a technical agreement and an audit
- Contract Manufacturers (CMOs) — require a full Quality Agreement and a GMP audit
- Cloud and IT providers with GxP systems — require a CSP assessment and a technical agreement
Common error
The company assumes that an external partner “probably complies with GMP.”
During an inspection, the contracting company is responsible—and must be able to document that the partner has been approved and audited.
Checklist:
What is your GMP level?
| Questions | Yes | No |
| Are you familiar with the SOPs that apply to your role? |  | |
| Do you document your actions in a timely and accurate manner? | | |
| Do you report discrepancies—even those that seem insignificant? | | |
| Have you taken any GMP courses within the last 12 months? | | |
| Have all external partners been approved and audited? | | |
| Have the production areas been cleaned, and have hygiene requirements been met? | | |
Do you need to brush up on your GMP knowledge or help new colleagues get off to a good start?
Here, you'll get knowledge you can use for upskilling, training, and your GMP work.
Use it in practice
- Quick exercise: Ask the team to identify two instances in their daily work where GMP principles are evident. Share and discuss.
- Consider the risk of these three types of contamination in your production process.
- Glossary: What do 'batch', 'deviation', or 'line clearance' actually mean? Find answers in our GMP glossary
Download the GMP Dictionary (search for Pharmakon): App Store (iOS) or Google Play (Android)