QM and GMP consulting

In brief

Every site that manufactures, tests or places on the market medicinal products or active substances needs a functioning quality management system. It defines how deviations are investigated, how corrective and preventive actions (CAPA) are managed, how changes are assessed and risks evaluated, and how management regularly checks whether the system is effective. Quality management consulting provides support in setting up the system, revising it or preparing for an inspection.

Good consulting does not simply write standard operating procedures. It helps the site run a system that suits its size and its activities and that its people actually use in daily work. Responsibility for the system always remains with the company’s management.

When you need it

A common reason is setting up a system: a start-up applies for its first manufacturing authorisation, a laboratory wants to offer GMP testing, or a company takes on the role of marketing authorisation holder. A second reason is findings from an inspection or a customer audit, which must be answered with a robust action plan. A third is inspection preparation. Under Section 64 of the German Medicines Act (Arzneimittelgesetz, AMG), sites holding an authorisation under Section 13 AMG are usually inspected every two years, and an independent outside view is worthwhile before such an inspection.

In addition, there are ongoing tasks for which capacity is lacking, such as the annual product quality review, working through a backlog of open deviations or adapting risk procedures to the revised guideline ICH Q9(R1).

Legal basis and rules

Section 3 of the German Ordinance on the Manufacture of Medicinal Products and Active Substances (Arzneimittel- und Wirkstoffherstellungsverordnung, AMWHV) obliges sites to operate a functioning, fully documented quality management system whose effectiveness is reviewed regularly, and for medicinal products refers to Part I of the EU GMP Guide. Its Chapter 1 describes the pharmaceutical quality system, and the ICH guidelines Q9 and Q10 are contained in Part III.

Deviations, CAPA and changes under Chapter 1

For the investigation of deviations, product defects and other problems, Chapter 1 requires an appropriate root cause analysis, whose depth depends on the risk. If the actual root cause cannot be found, the most likely causes should be identified and addressed. Where human error is assumed to be the cause, it must be justified why process, procedural or system-based errors have been ruled out. The investigations lead to corrective and preventive actions, whose effectiveness is monitored.

Planned changes are assessed and approved before implementation, including a check of whether the authority must be informed or must approve. After implementation, it is checked whether the objective was achieved and whether there were unintended consequences for product quality. Management reviews the system regularly, and a product quality review is usually prepared annually for each authorised medicinal product.

Risk management under ICH Q9(R1)

The revised guideline makes clear that formality in risk management is not an either-or choice but a spectrum, and that effort and documentation should match the risk. It also requires subjectivity in risk assessments to be recognised and reduced, and expressly includes risks to the availability of medicinal products.

How the collaboration works

What to look for when choosing a consultant

Frequently asked questions

Sources

Every statement in this text was checked against these primary sources (as of 10.11.2026). Laws, guidelines and authority websites, no advertising.

1. EU-Kommission (EudraLex) · eudralex-volume-4_en
2. EU-Kommission (EudraLex) · e458c423-f564-4171-b344-030a461c567f_en
3. EMA · ich-q9-quality-risk-management-scientific-guideline
4. ICH · ICH_Q9(R1)_Guideline_Step4_2022_1219.pdf
5. ICH · Q10 Guideline.pdf
6. Gesetze im Internet · __3.html
7. Gesetze im Internet · __64.html