Labelling QM

Beside Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) further fields require a functioning QM system namely labeling and medicinal product information.     CSO Pharma supports you in establishing and optimising processes for preparation and update of labelling, leaflets and Summary of Product Characteristics (SPCs), information material and advertising texts.  

Standard Operating Procedures

  • Preparation and maintenance of corresponding standard operating procedures (SOPs)
  • Establishment of specifications
  • Templates and checklists

Monitoring and Release

  • Configuration management
  • Follow-up and change control
  • Release and distribution of pack material and product information
  • Information Officer

Assessment

  • Assessment and CAPA
  • Audits to assess conformity of pack material development, processing and management

Please feel free to contact us to get answers for efficient solutions. We are looking forward to your enquiry.

Medical enquiries

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Product information

As given for marketing authorisations medicinal product information texts (i.e. SPC) are also subject to strict regulatory requirements >>