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 & 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.  

MEDVACON's client, a fully integrated oncology drug research and development company with expertise in drug discovery, crystallography, medicinal chemistry, preclinical development, pharmacology, pharmaceutical development, CMC (chemistry, manufacturing, and control), global clinical trials, and regulatory affairs, engaged CP to conduct IT CSV/GMP Audits of their clinical system suppliers.  MEDVACON's Auditor works in conjunction with the clients internal Quality Department to jointly audit client's suppliers in an ongoing basis.  CP prepares the audit agenda, conducts the onsite IT CSV/GMP audits, Conducts daily closeout meetings with client, prepares and delivers the audit reports to our client. 

MEDVACON's client identified the need to audit their hosting service provider, who provides the hosting services for their Trackwise quality documentation management system. The hosting service provider was last audited by client in 2015. As part of the ongoing effort to maintain quality systems in a state of documented compliance client has engaged MEDVACON to perform the Computer System Validation (CSV) and GMP audit of hosting provider with lat two location, one in NJ and the other in VA.  This client has a specific auditing SOP to be followed.  MEDVACON's auditor conducted the following scope: Prepare Audit agenda: Conduct Audit preparation activities; Perform on site CSV/GMP audits of the hosting service provider; Report critical observations to client at daily closeout meeting; Conduct Client Debrief Meeting, Executive Summary and initial observations preparation; Develop Audit Report including observations; Prepare Audit Result letters and CAPA Request for submission to vendor; Issue Vendor Audit Certificate; Conduct CAPA review and Follow-up Discussions.

MEDVACON's client identified the need to audit their hosting service provider, who provides the hosting services for their Trackwise quality documentation management system. The hosting service provider was last audited by client in 2015. As part of the ongoing effort to maintain quality systems in a state of documented compliance client has engaged CP to perform the Computer System Validation (CSV) and GMP audit of hosting provider with lat two location, one in NJ and the other in VA.  This client has a specific auditing SOP to be followed.  MEDVACON's auditor conducted the following scope:

Prepare Audit agenda: Conduct Audit preparation activities; Perform on site CSV/GMP audits of the hosting service provider; Report critical observations to client at daily closeout meeting; Conduct Client Debrief Meeting, Executive Summary and initial observations preparation; Develop Audit Report including observations; Prepare Audit Result letters and CAPA Request for submission to vendor; Issue Vendor Audit Certificate; Conduct CAPA review and Follow-up Discussions.