Supplier and Contract Partner Audits
What are Supplier and Contract Partner Audits
Compliance issues incurred by your external vendors and suppliers quickly become your compliance risks. Regulatory authorities require firms to provide adequate oversight of their partner organizations to quickly identify and mitigate any issues that could harm patients or otherwise impact the safety, identity, strength, purity, or quality of the product as defined in applicable regulations. A defined process for identifying, qualifying and overseeing external partners across your entire supply chain is both a regulatory requirement and a critical part of sustaining your ability to deliver safe products to patients.
MEDVACON understands the challenges of virtual organizations that rely heavily on external partners to get things done, as well as those who manage complex supply chains. Our auditing and quality system experts can provide guidance that is tailored to your unique situation and needs.
Example Projects:
cGMP & Quality Audit - Contract Manufacturing & Contract Laboratory
MEDVACON’s client is a pharmaceutical company whose mission is not one of drug discovery, but rather that of acquisition and commercialization of prescription products that will satisfy unmet clinical needs in specialty therapeutic areas. This “virtual company” outsources the manufacture, pharmaceutical development, packaging, and testing of their products. Client has engaged MEDVACON to provide cGMP and Quality Audits for one of their Contract Manufacturing Organizations (CMO) who also packages their product and one of their Quality Control testing Laboratories, both located in New England.
cGMP & Quality Audit - Contract Manufacturing & Contract Laboratory
MEDVACON’s client a CMO is a contract manufacturing organization that specializes in the formulation development and commercial services for oral solid dosage products. As part of the client’s continuing dedication to excellence, they identified the need to engage MEDVACON to support the internal audit of their quality organization in support of maintaining a strong GMP compliant organization. MEDVACON performed a high-level audit of the critical quality functions within the CMO’s quality organization. A report was developed and issued and presented to the client. The client engaged MEDVACON to conduct facility-wide cGMP training for all facets of their staff.
cGMP & Quality Audit - API Supplier, Contract Laboratory & API Storage Warehouse
MEDVACON’s client is a virtual pharmaceutical company and outsources the manufacture, pharmaceutical development, packaging, warehousing, distribution and testing of their products. The client has engaged CP to provide a cGMP & Quality Audit for one of their Active Pharmaceutical Ingredient (API) manufacturers in CO, another cGMP audit for their contract laboratory located in WI, and the third for their API storage warehouse located in IA.
CSV & cGMP Audit of Hosting Systems Provider
MEDVACON’s client identified the need to audit their TrackWise quality documentation management system hosting service provider, last audited by client in 2015. As part of the ongoing effort to maintain quality systems in a state of documented compliance, MEDVACON completed Computer System Validation (CSV) and GMP audits at New Jersey and Virginia locations. Adhering to the client’s specific auditing SOP, MEDVACON’s auditor conducted developed the scope around the audit agenda outlining preparation, onsite CSV/GMP audits of the hosting service provider, reporting critical observations to client at daily closeout meeting, and CAPA request for submission to vendor. MEDVACON ensured that the vendor audit certificate would be issued and CAPA review would be completed during follow-up discussions.
