QUALITY ASSURANCE

GxP SOPs Development / Maintentance - Audits - Training

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

It is the Policy of Creative Pharma & HR Services to achieve and maintain the highest Quality performance in providing its services. Highest Quality performance implies an explicit understanding of the Client, the Client’s needs and the service requirements. It also implies adherence to applicable national & international regulatory requirements and Quality and Information Security International Standards and a commitment in continually improving.

It is the objective of Creative PHS to embody its commitment to highest Quality into every aspect of its operations. This is sustained through the conservation of a corporate posture which embraces a climate of defect prevention rather that defect detection. Ηighest Quality performance also implies a level of employee achievement that reflects an unremitting pursuit for excellence. This performance is feasible through methodical training, encouragement for professional growth, motivation for Quality consciousness, prompt allocation of resources and structured process control and monitoring activities.

Towards meeting this objective, Creative PHS has developed, implemented and monitors a Quality Management System in line with the requirements of the International Standard ISO 9001, as well as an Information Security Management System in line with the requirements of the International Standard ISO 27001; both, also successfully certified for compliance with the Data Protection legal framework, including the General Data Protection Regulation (GDPR).

Embodying this Quality culture and with an extensive experience in the health sector and the pharmaceutical industry, as well as highly skilled professionals, Creative PHS provides Quality Assurance Services including:

  • SOPs Development / Maintenance
  • Quality Audits Conduct (Internal, to Vendors)
  • Quality Audits / Inspection Support
  • Training
  • Development / Review of Technical Quality Documentation (e.g Validation, 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.
  • Internal Audit Scheduling, Conduct & Reporting.
  • Supplier Qualification. Maintenance of the Approved Suppliers List, and qualification of Suppliers with impact to GxP activities. Qualification can be performed through Audits, Written Questionnaires, Certifications Review, or other means, as per supplied product/service GxP impact.
  • 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)

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