GMP Compliance Management | Valicare GmbH

EU GMP guidelines require a quality assurance concept

The EU GMP guidelines require that manufacturer of pharmaceuticals, active ingredients, and excipients must set-up a GMP-compliant quality management system. Manufacturers must cover all quality-relevant areas and all quality assurance measures. Quality requirements not only apply to production processes. They include all areas and measures of the company that have impact on the quality of the pharmaceuticals. In addition to general quality management principles, several further areas must be controlled to ensure GMP compliance, i.e. personnel, premises, equipment, documentation, quality control, contract manufacturing, testing, complaints, product recalls, and self-inspection.

Compliance with GMP guidelines

All companies worldwide must comply with GMP requirements in order to obtain a manufacturing authorization (GMP certificate) for medicinal products or active pharmaceutical ingredients. In Germany, for example, the “Arzneimittel- und Wirkstoffherstellungsverordnung"(AMWHV) governs the application of Good Manufacturing Practice and refers to the much more comprehensive European regulations.

Many people and functions are responsible for GMP compliance: in addition to management, which is responsible for the implementation of the pharmaceutical quality system (PQS) and the availability of the necessary resources, management functions like Qualified Person (QP), Head of Manufacturing (LdH), Head of Quality Control (LdQC) and Quality Management Representative (QMB) as well as the executing employees of the plant, suppliers, and distributors must all have the necessary GMP knowledge and renew it regularly. Official inspectors check whether companies produce in GMP compliance and can obtain, maintain, or extend their manufacturing authorization. The corresponding GMP certificate is issued after each successful inspection. The regular interval is every three years.

Valicare has the GMP expertise

An objective, external compliance check is particularly valuable when preparing for inspections, or when setting up or expanding company structures in relation to new products and markets. Companies often lack the relevant experience or personnel resources. A certain degree of 'operational blindness' or 'old habits' can also lead to unpleasant surprises during inspections by the authorities.

Our lead consultants, who have gained many years of experience in implementing numerous and varied GMP projects, are very familiar with the handling of quality assurance tools. They offer comprehensive GMP compliance management support to clients in the pharmaceutical and biotechnology industries, especially to manufacturers of cell and gene therapy products.

These GMP services and a comprehensive service portfolio are also available remotely.

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Our Services in GMP-Compliance

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GMP/GxP Consulting

A team of permanent consultants, specialized in various fields of competence, supports our customers in the GMP-regulated industry in their tasks and problems with expertise and foresight.

GMP/GDP Certificate

If you like to manufacture medicinal products and/or investigational medicinal products in the European Union or wish to import them into the EU, you need the respective permission and the corresponding GMP certificate.

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GMP Life Cycle Management

When planning the qualification and validation activities of facilities, equipment, systems, products and processes, their life cycle phase is crucial!

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Good Laboratory Practice, GLP

GLP stands for Good Laboratory Practice and defines principles for the non-clinical and environmental safety study of substances or preparations.

GMP for Quality Control

Quality control (QC) is a central aspect in the manufacture of active ingredients and medicinal products and is essential to ensure and demonstrate product quality.

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Quality and GMP Services for R&D

It is a long way from R&D to GMP-compliant production. We accompany and support the manufacturing process of your investigational medicinal products.

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GMP and GDP Training

Regular GMP and GDP training is an important part of every GMP/GDP-regulated company.

GMP Documentation

GMP (Good Manufacturing Practice) is often jokingly translated as "a great mass of paper," and in fact, GMP-compliant documentation is very extensive and encompasses the entire Pharmaceutical Quality System (PQS).

GxP Audits and Mock Inspections

Execution of audits is the basis for system evaluation through pharmaceutical manufacturer, independently whether an internal department, a customer or a supplier is focused.

Medical Device Compliance

Valicare's long-standing experience within the medical device, biotechnology, and pharmaceutical industry allows us to detect and implement necessary extensions in the quality management systems of our customers...

Free first consultation now!

Dr. Ellen Sons-Brinkmann
Phone: +49 69 153 293 709

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News

Stay up to date with the latest developments and news from the world of Good Manufacturing Practice (GMP), Advanced Therapy Medicinal Products (ATMP) and Valicare. Our overview provides you with valuable insights to always keep you informed and competitive.

GMP Compliance

Professional GMP compliance ensures the quality of drugs and active ingredients.

Cell and Gene Therapy

ATMPs offer new, promising therapeutic approaches for diseases that were previously considered incurable. However, the regulatory requirements are challenging.

Brochures

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Our Company

Valicare is an ISO 9001-certified service company and operates in the area of qualification and validation of technical equipment and processes.

We ensure the quality of your drugs and APIs with GMP compliance support