GMProject


G.M.PROJECT is a company specializing in GMP (Good Manufacturing Practice) solutions, offering services such as automation, engineering, GMP consulting, and development centers. They provide training, documentation, validation, and other GMP-related services to the pharmaceutical and medical industries. The company is committed to supporting clients in achieving compliance and excellence in pharmaceutical manufacturing.

Industries

biotechnology
pharmaceutical
robotics

Nr. of Employees

small (1-50)

GMProject

Opava, Moravskoslezsky kraj, Czech Republic, Europe


Products

Camera inspection set for production line

Integrated camera inspection package for production-line analysis including an industrial notebook, inspection software, tripod, four lenses, lighting and dust/water protection.


Services

One-day workshop plus a package of validation templates (URS, DQ, Validation Plan, Risk Assessment, IQ/OQ/PQ and Final Validation Report) to support internal validation of computerized systems.

Courses covering thermal sterilization principles and radiation sterilization (gamma/electron-beam), process validation, dosimetry and bioburden estimation.

Training on pharmaceutical water types, applicable regulations and recommendations, system design considerations, qualification and maintenance practices.

Advanced microbiology course covering monitoring strategies, sampling, contamination source analysis and corrective/preventive actions for cleanrooms and sterile manufacturing.

Consulting on GMP readiness, process automation and engineering support for pharmaceutical production lines, including optimization and inspection automation.

Expertise Areas

  • GMP compliance and quality systems
  • Computerized system validation (Annex 11, GAMP-style risk-based approaches)
  • Sterilization process validation (thermal and radiation)
  • Water system design and qualification for pharmaceutical use
  • Show More (9)

Key Technologies

  • Computerized system validation frameworks (GxP, Annex 11, GAMP principles)
  • Simplified FMEA risk assessment
  • IQ/OQ/PQ qualification protocols
  • Thermal sterilization processes
  • Show More (7)

News & Updates

Czech innovative solutions for the pharmaceutical industry in Latvia

A meeting organized with clients in Latvia focusing on Data Integrity and specific needs of clients, supported by CzechTrade and the Czech Embassy in Riga.

Conference Robots2022 is approaching

A conference scheduled in Brno on April 21-22, 2022, focusing on robotics and automation in industry.

GMProject as participant on mission in Estonia

Participation in a business mission in Estonia to promote automation according to GMP principles.

Very sweet GMP training

GMP training at the Beekeeping Research Institute covering risk analysis and quality control.

Merry Christmas!

Holiday greeting from GMProject team thanking partners and customers for cooperation in 2021.

Czech innovative solutions for the pharmaceutical industry in Latvia

A report on a professional presentation and B2B consultations in Latvia.

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