GxP

PharSolution offers a comprehensive consulting service on issues regarding GxP and is specialised in GMP and GDP auditing and practices. With large experience in supporting pharma companies in the process of certification and renewal, we provide a cost-effective solution for a wide range of services:

• Assessment of Quality System and relevant documentation;

• Validation review of manufacturing equipment, product process and equipment cleaning;

• Review of method validation (analytical and microbiological);

• Evaluating data integrity and traceability;

• Assessment technical transfer for manufacturing and test methods;

• Gap analysis of the current GMP and GDP compliance level of a site with EU
  and international regulations and guidelines and evaluation of the preparedness
  of facilities for regulatory inspections;

• GMP and GDP audits and licensing;

• Support in the definition and implementation of CAPA
  (Corrective Action/Preventive Action) programs;

• Mock Inspection and preparation for EU GMP inspection;

• Auditing of contract manufacturers and suppliers, including API manufacturers;

• Provision of detailed audit report, listing relevant findings;
  triaged as critical, major, or minor and including full references to the pertinent
  regulations and guidance documents.