Aula GMP
Consultancy and training firm focused on Good Manufacturing Practices (GMP), quality assurance and quality control for the chemical‑pharmaceutical industry. Services include regulatory audit and inspection readiness (EU and FDA), GMP training (open and in‑company, including e‑learning), microbiological and aseptic process consulting, validation supervision and quality systems improvement.
Industries
Nr. of Employees
small (1-50)
Services
Regulatory and technical consulting for GMP compliance, including remote videoconference sessions for specific issues and short advisory engagements.
Execution of internal/external audits, supplier audits, data integrity audits and mock FDA inspections to prepare sites for regulatory inspections.
Oversight and technical review of validation protocols and reports provided by third‑party validators to ensure regulatory compliance and completeness.
Development of contamination control strategies, interpretation of microbiological results and improvement of aseptic practices.
Catalogue of courses covering GMP topics (Annexes, 21 CFR, data integrity, validation, microbiology, stability, GDP) delivered as open virtual courses or customized in‑company programs.
Regulatory and technical consulting for GMP compliance, including remote videoconference sessions for specific issues and short advisory engagements.
Execution of internal/external audits, supplier audits, data integrity audits and mock FDA inspections to prepare sites for regulatory inspections.
Oversight and technical review of validation protocols and reports provided by third‑party validators to ensure regulatory compliance and completeness.
Development of contamination control strategies, interpretation of microbiological results and improvement of aseptic practices.
Catalogue of courses covering GMP topics (Annexes, 21 CFR, data integrity, validation, microbiology, stability, GDP) delivered as open virtual courses or customized in‑company programs.
Expertise Areas
- GMP compliance and auditing (EU and FDA)
- Quality systems evaluation and improvement
- Validation and qualification (process, equipment, cleaning)
- Microbiological control and aseptic processing
Key Technologies
- Media fill simulations
- Sterile filtration validation
- Autoclave qualification (moist heat sterilization)
- Environmental monitoring for cleanrooms
News & Updates
Online basic course on Good Manufacturing Practices for newly hired staff or annual refresher; interactive video content, assessment and certificate; bonifiable by Fundae.
Case study describing an engagement to prepare a client for a successful FDA Pre‑Approval Inspection.
Project to implement a company‑wide GMP training plan for staff at an API manufacturing site.
Project to improve media fill (aseptic fill simulation) processes and results.
Online basic course on Good Manufacturing Practices for newly hired staff or annual refresher; interactive video content, assessment and certificate; bonifiable by Fundae.
Case study describing an engagement to prepare a client for a successful FDA Pre‑Approval Inspection.
Project to implement a company‑wide GMP training plan for staff at an API manufacturing site.
Project to improve media fill (aseptic fill simulation) processes and results.