QUALITY ASSURANCE

GxP SOPs Development / Maintentance - Audits - Training

…Quality is not an act, it is a habit
– Aristotle

Our Company’s primary objective is the delivery of high-quality services with consistency, reliability, and professionalism. Our core principle is the thorough understanding of our clients’ needs and full compliance with applicable National and International Regulatory requirements, as well as international standards for the Quality of Information Security. We place strong emphasis on continuous improvement of our processes, error prevention, and fostering a quality-driven culture throughout the organization. We consistently invest in the training and development of our people, ensuring they have the knowledge and tools required to deliver high-level services.

To support these commitments, Creative Pharma & HR Services is certified against ISO 9001 and ISO 27001 and operates an integrated Quality & Information Security Management System. In addition, the Company is certified and fully complies with the General Data Protection Regulation (GDPR) requirements for the protection of personal data.

With responsibility and transparency, we build relationships of trust and provide consistent, high-quality support in every collaboration.

Driven by this culture of Quality and our extensive experience in the healthcare and pharmaceutical sector, the Company provides Quality Assurance services such as:

  • Development / Μaintenance of procedures (within GxP and ISO frameworks),
  • Audits (Ιnternal and to Suppliers),
  • Supplier Assessments,
  • Support during Clients’ / Regulatory Authorities’ inspections,
  • Personnel training,
  • Development / Μaintenance of technical documentation (e.g., Validation Reports, Quality Agreements).
  • Development, Implementation, and Maintenance of the client’s Quality Management System (Policies/SOPs), in accordance with applicable contractual, legal, and regulatory requirements.
  • Maintenance of the Quality Management System may include:
    •       Development / Review, Revision and Distribution of Quality Management System Documents.
    •       New Contractual / Legal / Regulatory Requirements impact assessment on Quality Management System Documents.
  • Planning, Conducting and Reporting of an Internal Audit.
  • Conducting an evaluation through Audits, Written Questionnaires, Certificates Review, or other means, depending on the impact of the provided service or product on the client’s activities.
  • Audit / Inspection Readiness Training to involved client employees.
  • Physical or Remote Participation in Audits / Inspections towards the Client.
  • Training of personnel to the requirements of the Quality Management System (SOPs) and/or to general requirements (GxP training).

In accordance with current GxP, applicable contractual, legal, and regulatory requirements, and Quality Management System needs, to the extent required by the Client:

  • Process / Product Validation Protocols and Reports.
  • Facility or Equipment Qualification Documentation (URS/IQ/OQ/PQ Protocols/Reports)
  • Risk Assessment Plan / Report
  • Contamination Control Strategy
  • Product Quality Review
  • Quality Technical Agreements
  • Product Quality Complaints
  • Deviations / Non-Conformances & CAPAs
  • Change Controls
  • Arrangement and Reporting of Management Review Meeting (MRM)