GMP Services (Pharma & more) | Valicare GmbH

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GMP Compliance

Quality, safety, and efficacy of medicinal products are paramount to guarantee the well-being of the patients. Hence, the European Commission has defined quality standards for production processes and environments of medicinal products and active pharmaceutical ingredients (API) in the EU GMP Guidelines. The latter aim to ensure that medicinal products meet these high standards and comply with the requirements specified in standardized marketing authorizations throughout Europe.

Qualification & Validation

A GMP-compliant approach must be based on the Annex 15 of the EU GMP Guideline and the ECA Guide on Integrated Qualification and Validation. These guidelines specify that GMP qualification and validation have to be risk-based in order to estimate the effects of deviations on process stability and product quality, while controlling time and costs.

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Cell and Gene Therapy

Valicare GmbH provides both consulting and support from development to GMP-compliant manufacturing and offers turnkey production solutions for cell and gene therapeutics (ATMPs). If you are still in the development phase and don’t know which steps to do first and which regulatory requirements you need to follow: Our experts will be more than happy to advise you.

Large sterile device for the medical sector

Isolator Technology

Sterility is an essential requirement for filling parenterals. Our Valicare experts have the technical and practical experience to set up sterilization processes in isolators.

Medical Devices

Medical devices require high quality standards that must be ensured through a robust quality management system in accordance with ISO 13485. Implementation is complex and demanding.

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.

GMP ensures the quality of medicinal products