Confidence Beyond Compliance
Contractors, suppliers and other 3rd parties play a key role in today’s modern pharmaceutical industry. As pharmaceutical companies continue to look further afield in search of economical vendors, the regulatory expectations for Quality Management of these vendors are increasing in response to the degree of the associated and increasing risks. Outsourced activities such as clinical trial management, manufacturing, analysis, warehousing, and distribution are commonplace. Companies supplying raw materials and packaging supplies must also be assessed in terms of compliance and there must be a system in place for the on-going monitoring of suppliers.
Regulatory guidelines relating to GxP Vendor Management emphasize the importance of oversight and the Quality / Technical Agreement (QTA or QAG) between you and your contract third parties.
PharmaLex’s Quality Management and Compliance experts provide fully comprehensive GxP Vendor Management and Oversight services, including,
- Vendor management compliance assessments of your organization to ensure that all GxP third parties are identified across the functional areas of your organization, for example, manufacturing, distribution, medical affairs, and appropriate control measures are implemented.
- Vendor due diligence and qualification auditing.
- Development of your Vendor Metrics that assesses each vendor using both leading and lagging metrics.
- Development and implementation of effective system procedures for the initial evaluation, and on-going monitoring of vendors to ensure compliance and oversight, as an element of the Pharmaceutical Quality System (PQS). This includes documenting appropriate procedures for evaluating (including auditing), qualifying and monitoring performance of these contractor groups, including periodic re-qualification.
- Development of your risk-based vendor audit program.
- Developing or improving the Quality / Technical Agreements with your third parties.
- Performing comprehensive tailored GxP audits of your organization’s contractors, suppliers and 3rd parties, both in developed and developing countries, in compliance with applicable regulatory requirements and expectations.
What our clients say
During the bid defense we felt that you worked well as team and are very dynamic. Preparation of such a complex dossier really needs to be done in such a way.
VP Regulatory Affairs
Rina and the team were brought in to help support us during the PMCPA complaint process and subsequent audits. Their expertise and approachability made this difficult process smooth. True professionals and a pleasure to work with!
Head of Ethics and Compliance, Astellas Pharma Europe