Quality System Audits / Gap Assessments

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 CP 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 

 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 an 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. 

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.  

For a fully integrated oncology drug research development client with expertise in drug discovery, crystallography, medicinal chemistry, preclinical development, pharmacology, and pharmaceutical development, MEDVACON conducted IT CSV/GMP clinical system supplier audits in conjunction with the client's internal quality department. CP prepared the audit agenda, conducted the onsite IT CSV/GMP audits, conducted daily closeout meetings with client, and prepared and delivered the audit reports to our client.

MEDVACON's client identified the need to audit their Track wise 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.