EU GMP

  • EU GMP – audits, trainings, implementation & support in CAPA
    • EU QP led audits and inspections
    • Formal inspection preparedness – mock-up audits
    • Quality systems auditing and review
    • Computerized systems audits
    • General cGMP compliance audits
    • Support in compiling EU format Site Master Files
    • EU GMP trainings and Pharmaceutical Quality System implementation - working with client’s quality department, providing bespoke training in relation to the current GMP status and defined targets.
    • Full support in CAPA (plans, realization and reporting)
  • EU GMP formal Certification – facilitation in appointing, support in organization, execution and CAPA resolution/management
    • Preaudits by EU GMP experts, preparation for formal inspections
    • Trainings for receiving an EU GMP formal inspection
    • Facilitation in appointing of formal EU GMP inspections
    • Full support for the audits
    • Full support in CAPA (plans, realization and reporting)
  • PQS/QMS development, trainings, consulting & support
    • Full support in setting up, development and implementation of the Pharmaceutical Quality System as per ICH guideline Q10 on pharmaceutical quality system
    • Trainings, Coursers, Seminars
    • Support in SOP writing, SOP trainings, review, verifications
  • Qualifications, Validations & Metrology services with accredited laboratory
    • VALIDATION AND QUALIFICATION
      • Validation Policy (SOPs), Validation template documents, Validation Master Plan and Impact Assessment
      • Qualification of utility systems – HVAC, PW, Compressed Air
      • Calibration of production and QC lab equipment
      • Calibration of measuring instruments on site (temperature, humidity, pressure)
      • Qualification of QC lab and production equipment and lines
      • URS development
      • IQ/OQ/PQ protocols, support in both writing and execution,
      • Production process validation, cleaning and sanitization process validation
      • Document check, Verification and Harmonization for all listed above
      • Verification and qualification of present (installed) or new computerized information systems
      • Warehouse qualification (included summer and winter temperature mapping)
      • Support for establishing operations of the Maintenance and Validations (Metrology) Department on-site, by validation experts and EU accredited metrology laboratory, with support in training and equipping of validation/calibration instruments.

    • COMPUTERISED SYSTEMS AND SOFTWARE VALIDATION
      • Quality management of computer systems (hardware and software) is a central part of the overall quality management system in the pharmaceutical industry. In addition, quality management of electronic signatures and electronic records (i.e., data generated by computer systems) is also part of the overall quality management system. Computer systems must comply with cGMP requirements, when used in these regulated environments.
      • Documented process for testing computer software and systems, required by 21 CFR 11.10(a) and EudraLex, The Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practice, Annex 11: Computerized Systems
      • Verification of delivered documentation for computerized systems and software