Pharmaceutical

Industries

Sterile Pharmaceutical

The design of a correct contamination control strategy of microorganisms, particles, endotoxins and pyrogens is critical in the manufacture of sterile medicines. We have more than 15 years of experience in the manufacture of sterile APIs by aseptic process in leading companies in the sector, therefore, we have full confidence that we can implement the high-quality standards required by Annex I of the European GMPs, in a practical and useful way.

We can also carry out projects tailored to your needs to detect and correct deficiencies in your contamination control strategy or improve processes to minimize the microbiological, non-viable particles and pyrogens risk of contamination.

  • Development and implementation of the contamination control strategy (CCS).
  • Advice on the design of clean rooms and the design and drafting of SOPs:
    • Personnel flow.
    • Materials flow.
    • Garments:
      • Cleaning and disinfection.
  • Risk assesment.
  • Validations:
    • Thermal.
    • SIPs.
    • Aseptic process.
    • Cleaning and disinfection.
    • Equipment cleaning.
      • Garments life cycle.
  • Audits to suppliers, CMOs and data integrity.
  • Health authorities audit preparation:
    • FDA (Food and Drugs Administration)
    • EMA (European Medicines Agency)
    • AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)
    • KFDA (Korea Food and Drug Administration)
      • ANVISA (Agencia Nacional de Vigilancia Sanitaria)

Oral Pharmaceutical

The oral pharmaceutical industry is highly regulated and subject to strict regulations and quality requirements to ensure the safety and efficacy of medicines. Drugs that do not meet established standards can put patients' health at risk.

That is why, at tri-consulting, we want to help you by providing advice and guidance on Quality in all of your business aspects. We offer a wide range of Quality consulting services, from reviewing and improving manufacturing processes to design and execute action plans to correct gaps in your quality system. In addition, we offer training to your staff on Quality-related issues to ensure they stay up-to-date on the latest regulations and norms.

  • Audit of gaps detection in GMPs, GDPs and preparation of sanitary audits.
  • Implementation and maintenance of continuous improvement processes (Kaizen).
  • Audits to suppliers, CMOs and data integrity.
  • Advice on the design of clean rooms and the design and drafting of SOPs:
    • Personnel flow.
    • Materials flow.
    • Garments:
      • Cleaning and disinfection.
  • Implementation of LEAN tools.

industries

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