Pharmaceutical Solutions provides a range of Quality Assurance and Quality Management System assistance to pharmaceutical customers' sites including API and finished product manufacturing sites, quality control testing facilities, storage and distribution sites and clinical trial sponsors.

Examples of services include:

• QMS Assistance
  • Developing and implementing entire quality systems for specific operations such as Storage and Distribution, Importation testing or finished product manufacture. 
  • Writing of specific quality system units such as a package of Quality Assurance documents, or a package of Production documents.
  • Devising and executing documentation for specific systems such as Deviation or Change Control.
  • Assessment of existing quality systems through gap analyses and reporting of results.
  • Rewriting of quality systems based on gap analyses.
     
• Training
  • Provision of comprehensive training for all documentation systems written or revised.
  • Provision of general GMP and GDP training, including annual GMP refresher training.
     
• Facility Readiness Preparation and Improvement
  • Pre-inspection audits either remotely or in person in order to detect potential non-conformances before they are observed.
  • Assisting sites with remedying detected non-conformances
  • Presence at inspection, if required.
  • Assistance with the generation of responses to inspections
  • Support with gaining new manufacturing authorisations
  • Assistance with self-inspection programmes, customer audits or corporate audits.
  • Help with compliance remediation projects following regulatory inspections
     
• Quality Assurance Emergency Cover
  • Provision of short-, medium- or long-term cover for Quality Assurance positions to assist with staff illness cover.
     
• Assistance with Modifications Required by Regulatory changes
  • Reviews of quality systems or practices against regulatory changes such as the implementation of the Clinical Trials Regulation (536/2014) or the changes brought on by Brexit to ensure continued compliance.

Please contact us if you are interested in discussing Pharmaceutical Solutions' QMS or quality assurance services.