Pharmaceutical Solutions is able to offer whole supply chain audit programmes as well as one-off audits to a range of different standards, including EU GMP and GDP, cGMP, ISO9001 and other ISO standards such as ISO/IEC 17025.

Pharmaceutical Solutions staff are IRCA qualified auditors with a range of expertise encompassing audits of:

• API manufacturers
• Finished product manufacturers of a wide variety of dosage forms
• Quality Control Laboratories
• Packaging and Labelling sites
• Storage and Distribution Sites, including EU/GB sites of physical importation
• Other supply chain sites such as master cell banks

Pharmaceutical Solutions staff have more than 50 years' collective experience of auditing and apply an open and consultative approach to audits. Audits can either be performed as standalone activities or as part of the assurance of a supply chain that the Pharmaceutical Solutions QP uses as part of importation and certification to clinical trial.

Audits are performed in collaboration with both the customer and the supply chain site/CMO. We are comfortable operating independently or as part of a customer audit team. The requirements of the customer and the product are at the forefront of any audit planning process.

Audits can also be carried out remotely, if this suits the needs of the customer’s supply chain. The quality management system of Pharmaceutical Solutions supports this option.

Audit site visits can also be combined with other tasks on behalf of customers, such as negotiating quality technical agreements or other contracts.

An audit quotation from Pharmaceutical Solutions is comprehensive and includes preparation time, including audit plan preparation, travel and accommodation costs, time spent auditing and time spend post-audit on writing up observations and the audit report.

Please contact us if you are interested in discussing Pharmaceutical Solutions' auditing services.