Internal audits

An internal audit (self-assessment) can provide insight in the existing deviations from GMP and GDP compliance. It is important to identify the root cause of the compliance gap in order to be able to effectively implement the proper corrective actions.

Pharmatech performs internal audits on request, and will assess the quality system compliance with current regulations. The assessment results in a clear and comprehensive report with recommendations how to effectively improve the quality system.

Where necessary we can create a plan for remediation actions and guide the client (project-based) through the implementation of the actions to bridge the compliance gap.

External audits

To provide a drug product of good quality the whole chain of manufacturing and supply needs to perform at maximum level to deliver a compliant product or service. As manufacturer and/or wholesaler you have the responsibility to evaluate and assess the compliance of your supplier with current regulations.

Pharmatech can assist you during this assessment process. We have the expertise to identify supplier’ deficiencies in compliance on national as well as international level. We have, for example, the expertise to assess contract manufacturing organisations, manufacturers of packaging materials, manufacturers of raw materials (chemical and biotechnological), cleaning services, IT-services, waste treatment and maintenance services.

Pharmatech also assists in the development and implementation of technical agreements (TA Agreement, QA Agreement or SLA).