GDP documents – Quality Management System

  • Preparation and implementation of the full documentation / QMS requirements of the Good Distribution Practice guidelines
  • Pharmaceutical warehouse audits
  • Rating of supervision of subcontractors
  • Qualification and quality audit of subcontractors services
  • Audit of customers / suppliers of products
  • Full advice on the process of starting a pharmaceutical warehouse (participation in inspections conducted by state authorities, to participate in audits conducted by external entities)
  • Preparation of risk analysis
  • Conducting training implemented documentation

Qualification/Validation

  • Development of the validation master plan
  • Qualification of premises (storage rooms, cold rooms)
  • Qualification of equipment
  • Qualification auxiliary systems
  • Qualification of personnel
  • Supervision over the validation of computer systems
  • Storage process validation
  • Validation of the transport process
  • Validation of the processes
  • Implementation of the re-validation programs

Mapping

  • Warehouses mapping
  • Mapping of transport vehicles in the full range
  • Risk analysis, analysis of the distribution of measurement points, an indication of the critical areas

Transport

  • Comprehensive preparation of transport / shipping for compliance with the latest requirements of the Good Distribution Practice (international transport, domestic transport)
  • Preparation of the transport / freight forwarding services to the logistics of clinical trials (international transport)
  • Qualification of transport
  • Validation of the transport process
  • Evaluation of existing transport documents
  • Preparing transport company in the full range
  • Analysis of transport costs, the profitability of transport routes

Warehouses

  • Technical audits
  • Good Distribution Practice compliance audits
  • Full support for both factual, legal and technical preparation of the distribution center, logistics, warehouse and loading bay for the provision of services for the pharmaceutical industry (Good Manufacturing Practice and Good Distribution Practice)
  • Flow of goods mapping
  • Preparation of warehouses schemes

Validation Department of PCS is run by the Head of the Validation of 15 years of experience in conducting validation according to Good Manufacturing Practice guidelines in the process of validation and revalidation systems, qualifications, technical equipment, mapping and classification of premises and warehouses.

Each project team consists a lawyer, certified auditor and a person having, among others, at least 10 years of experience in wholesale distribution (quality manager, warehouse manager, logistics manager).
Our specialists have many years of experience in outsourcing logistics services for the pharmaceutical sector organizations, pharmaceutical wholesalers, customs warehouses as well as the conduct of their service.
We can boast of several years of practical experience in the creation and implementation of a dossier satisfying the latest requirements of the Good Distribution Practice and many completed implementation projects in the area.

Since many years we cooperate in most of the projects with our partnership company CentrumDPD. Their huge experience, wide knowledge and flexibility to propose different solutions is highly appreciated by the pharmaceutical market.