- Quality and Scientific Regulatory Services for Global Bio-/Pharmaceutical Industry
Third Party QP Audits, Vendor Qualifications & Due-Diligence
Evaluation of the GMP status of API manufacturing units on behalf of EU QPs, to confirm satisfactory compliance before product filing or commercialization.
API QP AUDIT
Third Party API QP Audit
Experienced EU QP Auditor
Audit
3 Years
CAPA
Submission to Single EU GP
CAPA Acceptance by EU QP Auditor
QP
Informal Mileage
- One- time audit by an independent auditor for single API
- Conserves company’s resources (i.e. cost of travel and stay for buyer specific auditor, one-time engagement of manufacturing and QA personnel)
- One single QP audit can replace numerous MA holder audits
- Single comprehensive CAPA execution to independent EU QP auditor as against multiple CAPAs to different EU QP auditors
- Reduced major observations during renewal inspections since EU QP audit by ex-agency inspector
VENDOR QUALIFICATIONS
Audit of Suppliers for the pharmaceutical and medical device industries to ensure compliance with Good Manufacturing Practices and ISO standard requirements.
Vendor Qualification & Supplier Verification performed by Metina will cover the following areas for Compliance with regulatory requirements:
The effectiveness of the quality management system (QMS) is a critical aspect of the audit. The QMS must be designed to ensure that all processes, from design and development to manufacturing and distribution, are monitored, documented and verified for compliance with quality standards and regulations.
Adequate documentation and record-keeping are essential for ensuring product compliance and traceability. The audit should verify that the manufacturer’s records are accurate, complete, and current.
During the audit, it is important to evaluate the manufacturer’s personnel training and qualification procedures to verify their effectiveness in ensuring that employees are adequately qualified to carry out their assigned duties.
The audit should review the manufacturer’s product quality control procedures to ensure that the products meet the required specifications and are manufactured under proper conditions.
The manufacturer’s process validation procedures should be evaluated to ensure that they are appropriate, complete, and effective in ensuring product quality and consistency.
The audit should evaluate the manufacturer’s risk management practices to ensure that they are adequate to identify and control potential risks associated with the design, manufacture, and distribution of the product.
DUE-DILIGENCE FOR MERGERS AND ACQUISITIONS
With its core expertise in the area of quality, compliance and regulatory affairs, Metina is well equipped to provide technical consulting to financial institutions / pharmaceutical companies to facilitate decision making for investment/ divestment projects.
Our team comprising quality, regulatory and portfolio experts can assist in the following areas:
- Evaluation & ranking of technical capabilities of site/ company for long term business viability
- Unbiased technical opinion to support decision making in case of business insolvency
- Business risk mitigation by gap remediation for US/EU covering GMP norms/Warning Letters/Import Alert/NC
- Due diligence & Expert Opinion on robustness of product pipelines & approvals (ANDA/ANDs/MAA/CEP/DMFs)
- Commercial assessment of product portfolio to determine business viability