Solutions for Pharmaceutical Auditing

Flexible auditing solutions, including shared audits, for pharmaceutical Good Manufacturing Practice (GMP) for processes, equipment, facilities, utilities, quality control, and quality systems. Sanray is your partner for auditing all of your pharmaceutical product lifecycle suppliers, subcontractors, and service providers.

Pharmaceutical supplier and subcontractor audits are still an important element of the drug research and manufacturing process for analysing, monitoring, and improving quality control over your supply chain. GMP compliance is expected across pharmaceutical manufacturing supply chains by all regulatory agencies that set standards for the sector. As a result, pharmaceutical businesses must engage with their supply chains, which are becoming increasingly complicated, including a plethora of suppliers and subcontractors at various stages of the manufacturing process.

Our quality system, as well as our auditor qualification procedure, are frequently evaluated by our clients, with excellent results in terms of reliability and robustness. Private or individual audits, shared audits, CAPA evaluation and follow-up, audit report purchasing, remote audits, and support for your internal audit programme are all available through Sanray’s adaptable options. Suppliers and manufacturers of APIs, excipients, packaging materials, and other materials, as well as subcontractors in manufacturing, packaging, and analytical testing, clinical trial service providers (CROs), pharmacovigilance, transporters, IT services, cleaning services, and other services, are all audited.

These audits are carried out in accordance with the applicable regulatory texts or standards, such as Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Pharmacovigilance Practice (GPVP) (GVP). We also conduct audits in accordance with IPEC guidelines for pharmaceutical excipients, ISO 22716 (Cosmetics — Good Manufacturing Practices), EFfCI GMP for cosmetic ingredients, ISO 15378 standard for packaging materials, ISO 13485 standard for medical devices, ISO 9001 standard, or EHPM Quality guide for food supplements.