Supplier Quality
A rigorous supplier quality program that ensures every material entering our facilities meets the highest standards for pharmaceutical packaging.
PROGRAM OVERVIEW
Supplier Quality Program
The quality of pharmaceutical packaging begins long before a product reaches a packaging line. It begins with the materials, components, and services sourced from the supply chain. Meridan operates a comprehensive supplier quality program designed to ensure that every component entering our facilities, from primary packaging materials and printed cartons to labels, inserts, and ancillary materials, meets the rigorous quality standards required for pharmaceutical applications.
Meridan's supplier quality program is managed by a dedicated team of supplier quality professionals who bring deep expertise in pharmaceutical material specifications, incoming inspection methodologies, and supplier audit practices. The program is built on the principle that suppliers are strategic partners in the quality chain, not merely vendors. Meridan invests in developing strong, collaborative relationships with its supplier base, grounded in clear expectations, open communication, and mutual commitment to continuous improvement.
The supplier quality program encompasses four core elements: supplier qualification, incoming material testing, ongoing supplier auditing, and performance monitoring through vendor scorecards. Together, these elements create a comprehensive framework that manages supply chain risk while ensuring consistent material quality across all three Meridan facilities.
Meridan maintains a centralized Approved Supplier List that governs procurement across all facilities. This ensures that regardless of which Meridan site a customer's product is packaged at, the same qualified suppliers and the same material specifications are used. Centralized supplier management also enables Meridan to leverage its combined purchasing volume to drive quality improvements and supply chain reliability across the network.
QUALIFICATION
Supplier Qualification Process
A structured, four-stage process that ensures only qualified suppliers provide materials for pharmaceutical packaging operations.
Initial Assessment
Every potential supplier undergoes a comprehensive initial assessment that evaluates their quality management system, regulatory compliance history, manufacturing capabilities, financial stability, and business continuity planning. The assessment includes a detailed supplier questionnaire, review of quality certifications and regulatory registrations, and evaluation of the supplier's track record with similar pharmaceutical customers. Risk-based criteria determine whether the supplier can proceed to the next stage of the qualification process.
On-Site Audit
Suppliers of critical materials and components are subject to on-site quality audits conducted by Meridan's supplier quality team. These audits evaluate manufacturing processes, quality controls, testing capabilities, document management, change control procedures, and facility conditions against cGMP requirements and Meridan's internal standards. Audit findings are documented in formal reports with risk-rated observations. Critical and major findings must be resolved with verified corrective actions before the supplier can proceed to qualification testing.
Qualification Testing
Materials from prospective suppliers undergo qualification testing that verifies conformance to all applicable specifications, including dimensional tolerances, material composition, functional performance, and compatibility with Meridan's packaging equipment and processes. Qualification testing may include accelerated stability studies, machine trials on production equipment, and compatibility assessments with specific pharmaceutical products. Testing protocols and acceptance criteria are defined in advance and approved by quality and technical operations.
Approved Supplier List
Suppliers that successfully complete the initial assessment, on-site audit, and qualification testing are added to Meridan's Approved Supplier List (ASL). Inclusion on the ASL authorizes procurement to source materials from the supplier for production use. ASL status is reviewed periodically through ongoing performance monitoring, re-audit schedules, and annual supplier reviews. Suppliers that fail to maintain acceptable quality and delivery performance are placed on probation or removed from the ASL through a formal disqualification process.
TESTING
Incoming Material Testing
Every shipment of packaging materials received at a Meridan facility undergoes incoming quality inspection before it is released for production use. The scope of incoming testing is determined by the material type, its criticality to product quality, and the supplier's historical performance. Sampling plans are based on ANSI/ASQ Z1.4 (ISO 2859-1) acceptance sampling procedures, with inspection levels calibrated to the risk profile of each material and supplier combination.
Incoming inspection activities include visual examination for defects and damage, dimensional verification against approved specifications, print quality assessment for pre-printed components, barcode and data matrix readability verification, and material identification confirmation. For critical components such as primary packaging materials that directly contact pharmaceutical products, additional testing may include material composition verification, extractables screening, and functional performance testing on production equipment.
All incoming materials are held in quarantine status until inspection is complete and a formal release decision has been made by quality personnel. Materials that fail to meet specifications are segregated, documented through the nonconforming material process, and dispositioned through rejection and return, supplier corrective action, or, in rare cases where justified by risk assessment, use with documented justification and customer approval. Incoming test results are tracked by supplier and material to support trend analysis and vendor scorecard reporting.
AUDITING
Supplier Audit Program
Meridan conducts ongoing supplier audits as part of its supplier quality maintenance program. The audit schedule is risk-based, with frequency determined by the criticality of the material supplied, the supplier's quality history, incoming inspection performance, and any changes in the supplier's operations, ownership, or regulatory status. Critical material suppliers are audited at least every two years, with more frequent audits triggered by quality events or performance trends.
Supplier audits are conducted by qualified auditors using standardized audit checklists that cover quality system elements, manufacturing controls, testing capabilities, material traceability, change management, and regulatory compliance. Audit reports classify findings by severity and require formal corrective action plans with defined timelines for resolution. Follow-up verification ensures that corrective actions are effectively implemented and sustained.
In addition to scheduled on-site audits, Meridan reserves the right to conduct unannounced audits of critical suppliers and may conduct remote or document-based audits for lower-risk suppliers. The audit program also leverages third-party audit reports, regulatory inspection outcomes, and industry databases to supplement Meridan's direct assessment activities.
Vendor Scorecards
Meridan maintains vendor scorecards that provide quantitative, data-driven assessments of supplier performance across four key dimensions:
Incoming inspection pass rates, number and severity of nonconformances, CAPA responsiveness
On-time delivery rate, lead time consistency, order accuracy
Communication responsiveness, technical support quality, change notification timeliness
Documentation accuracy, regulatory standing, audit finding closure
Scorecards are reviewed quarterly and shared with suppliers during annual business reviews. Performance trends drive supplier development activities, recognition, or escalation actions.
Supplier Code of Conduct
Download Meridan's Supplier Code of Conduct, which outlines the ethical, environmental, labor, and quality standards we expect from every supplier in our network.
Download PDFREQUIREMENTS
Approved Supplier Requirements
All suppliers seeking approved status with Meridan must demonstrate compliance with the following requirements:
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