Confidence Beyond Compliance

Maintaining regulatory compliance across the product lifecycle is critical to ensuring the continuity of your operations. Whether your organization is virtual or fully in-house, auditing is a mandatory component of maintaining regulatory compliance.

Attaining a sustainable state of Inspection Readiness is the primary objective of your organization and your vendors. To achieve this, it is necessary to ensure that a robust and effective Pharmaceutical Quality System and Vendor Management Program is in place, as well as monitoring its ongoing effectiveness and suitability through periodic GxP Audit and Quality Management review.

Through the Quality Management and Compliance division, PharmaLex provides fully comprehensive GxP Audit services for both Vendor Management Programs and Internal Quality Maintenance. Based on your organization’s needs, PharmaLex will define the scope of the audit, assemble a High Performance Audit Team (as applicable), and will deliver a unified report addressing observations and remediation recommendations.

Vendor Management Program

PharmaLex provides a number of vendor management services; from developing the overarching Vendor Management Program (Standard Operating procedures (SOPs) and Agreements ), to providing GxP audits. The PharmaLex suite of Vendor Management Services includes:

  • vendor selection / due diligence
  • quality agreement development
  • development of a risk-based vendor management program, including Standard Operating Procedures (SOPs) and vendor metrics
  • GxP Vendor Audits (GCP, GLP, GMP, GDP, MAH , ISO and ICH)
Internal Quality Maintenance

PharmaLex provides a number of services to support continuous improvement and compliance, such as routine internal GxP audits, Gap Analyses, and Mock Inspections.  Additionally, PharmaLex provides regulatory inspection preparatory services for a variety of markets; USA, Canada, Europe, and Asia.

 

If you would like to discuss your requirements with us to see how we might be able to support your product development process, please contact us on contact@pharmalex.com.

PharmaLex has over 850 consultants spread across 31 offices in 17 countries. Of the 850 consultants, more than 200 belong to the Quality Management and Compliance (QMC) service portfolio. The QMC team has expertise in small molecule, biologics, ATMPs, combination products, medical devices, diagnostics and cosmetics with extensive expertise across the entire product lifecycle. Our consultants of Quality Assurance professionals include former Regulatory Inspectors, senior industry experts, and talented Directors, Managers, and Specialists. These experts ensure that the GxP Audit, Gap Analysis and Mock Inspection services are compliant with current international regulatory standards.

PharmaLex will develop a risk-based vendor management program specific to your needs. The vendor management SOPs and Procedures will include: vendor selection, rating the criticality of the vendors through Risk Assessment, audit schedule, and relationship maintenance.  The program will be in accordance with regulatory guidelines as well as industry best practices, such as qualifying all vendors and performing routine audits on a risk-based schedule. Additionally, PharmaLex provides tactical vendor management services including: Quality Agreement writing and negotiations; and routine vendor Quality to Quality discussions regarding CAPAs; deviations; and batch records.

PharmaLex Quality Management and Compliance has a team of 100+ auditors worldwide that come from a myriad of backgrounds. This allows for maximum flexibility to provide technically suitable and centrally located auditors to each audit when needed.  Audits are conducted using a “hat-on/hat-off” approach in which the auditor provides feedback to the auditee during the audit. This real-time mentoring improves auditee performance, preparedness and confidence for upcoming GxP inspections. PharmaLex auditors provide piece of mind auditing; they are responsible for all audit preparation, onsite audit, and final audit report.  Prior to audit, you will approve the audit agenda as well as the post-audit report. Following the audit, PharmaLex can support post-audit activities such as CAPAs and remediation activities to closure.

PharmaLex provides gap analysis and mock inspection services to prepare organisations, both virtual and in-house, for regulatory inspections in many of the major pharmaceutical and medical device markets including: USA, Canada, Europe, and Asia. PharmaLex typically recommends that Mock Inspections be executed over three consecutive days , by an audit team consisting of two Senior Consultants, one of which is a former Regulatory Inspector (for example, a former MHRA, HPRA or FDA Inspectors). Both the gap analysis and the mock inspection will review the entire Quality Program  as it currently stands and compare it to the elements of a Quality System that are mandated and / or recommended by regulatory authorities such as The U.S. Food and Drug Administration (FDA), EU Competent Authorities and the International Conference on Harmonization (ICH).