[Translate to en:] Was machen ein GMP-Expert:innen?

[Translate to en:]

GMP experts really are all-rounders – technical experts who are familiar with technical processes and sets of standards, and who feel at home there.

GMP experts understand how to interpret the applicable regulations. They know what counts and what auditors and inspectors want to see and hear. Typically they have a technical or natural sciences background. Their activities are defined by reliable documentation, transparency and accuracy.

Technical Qualification

Technically oriented people most commonly enter the GMP world through qualification. University graduates in particular have the opportunity to first concentrate on a machine or apparatus and examine it intensively. Details and functions can be learned using the documentation provided.

This newly acquired knowledge is then implemented in corresponding test plans. It is important for test descriptions to be formulated clearly and exactly. This is followed by conducting the tests and then compiling the results in a test report.

In short, the occupation of qualifier is defined by an in-depth examination of machines and apparatuses and the preparation of test plans. The variety of different technical systems (stirrer tanks, water and ventilation systems, clean rooms, tablet presses and many more) continues to pose exciting challenges. There is no routine here.

Process Validation

At its core, this job is also about the preparation of test plans. However, the focus here is on processes rather than machines and apparatuses. Process technology know-how is currently in demand in the many different chemical, biotechnology and pharmaceutical production, cleaning and sterilization processes.

The examination goes into the details. All conceivable critical points are studied in cooperation with plant operators in the course of risk analyses: What is the washing step on the centrifuge intended to accomplish? What parameters play a role here, and which ones are especially critical? Which of these require a particularly detailed examination during the validation study?

Moderation and communication skills are just as important in this field as statistical analysis knowledge, logical thinking and versatility. Often such a validation in the course of projects ultimately turns into process development that was omitted in the past.

GMP Documentation

Some say GMP stands for “Great Mass of Paper” – which is not entirely unjustified. Quasi every step has to be performed according to a process instruction, every deviation recorded, every change documented in detail and approved. A GMP operation has to administer several hundred such standard operating procedures (SOPs). First they have to be prepared.

The belief that this is a dusty, entirely paper-based matter is erroneous. The focus is not on the paper, but on the process. For a small business with few personnel, topics such as “training” or “change management” represent a challenge. Who in the team does what, who is responsible for what? How are records prepared and where are they stored? Key issues include process understanding, interviews with the persons concerned and proposing pragmatic solutions. In principle the paper, the SOP itself, comes last. The results are documented in a SOP only after the process is clearly established.

Gap Analysis

The initial situations for a review of the GMP requirements are manifold: A new product concept that requires GMP, pending production, considering whether an existing facility is still suitable or whether to build a new one. Where are the gaps in the system, and which ones need to be addressed with what priority?

But not only weaknesses are of interest. The examination also focuses on proposed solutions for closing such gaps quickly, easily and cost-effectively. An overview of processes, procedures, buildings, facilities and equipment needs to be obtained in a short time. The documentation is unerringly examined and the overall situation assessed in view of the GMP requirements.

GMP Projects

GMP experts not only accompany various project phases, but often also entire projects – quasi from the initial idea to the saleable product. Some tasks may be completed after a month while others can take years. Comprehensive GMP projects are certainly highlights for every engineer or natural scientist!

A new product concept, a new facility, for instance in China – does GMP apply?

Naturally GMP does apply in China. Western regulations have to be followed when the product is to be delivered to the west. GMP is therefore implemented around the world. Operator requirements are defined, specifying the facilities from the operator and the GMP perspectives. A qualification and validation system is established, the implementation is prepared. Close cooperation with engineering ensures that GMP aspects are consistently taken into account. Operator SOPs are written, personnel is trained, the process is validated and, as the crowning conclusion, the customer and facility are guided through the official inspection.

Onsite Support

Increasing competition, cost pressure and the expiry of patents mean that the pharmaceutical industry is increasingly driven by time-critical projects. It is therefore no wonder that calls for spontaneous and rapid support are growing louder. This is where the GMP expert of a service provider is in demand.

The GMP expert who works for the customer permanently on site basically faces the same tasks. For example, additional resources and knowledge carriers may be needed for a new construction or conversion project.

The range of possible support services is broad. Here the GMP expert is integrated into the customer's business and also subject to customer directives. They experience the GMP operation personally and work within the organization. Since GMP automatically means working across departments and therefore requires a great deal of communication, the focus is on mediation, conflict management and communication skills.

GMP Consultant

A GMP consultant combines the required technical and regulatory knowledge, often based on seven to eight years of practical GMP experience. Aside from technical and strategic matters, they can also handle business management challenges. They talk to engineers, production workers, management and directors. Key tasks of the GMP consultant include unerringly finding solutions to problems or accompanying official audits.

Flexibility is in demand. The experienced GMP consultant often travels domestically and abroad. New problems, questions and strategic challenges have to be understood quickly. A GMP consultant may work independently or as a group leader, providing the customer with a complete, worry-free GMP package. It's an occupation that many consider a calling.

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