cGMP & Mock FDA Audits
Whatever your company’s role in the life science supply chain – whether it is as a supplier, manufacturer or pharmaceutical, medical device or biotech company – demonstrating Good Manufacturing Practice (GMP) is key to securing customer trust, building your reputation and growing your business. A GMP audit from MEDVACON will show that you are meeting customer and consumer expectations and working to ensure the quality and safety of your products.
Pharmaceuticals, Medical Devices and Biologics must be produced consistently and must be strictly controlled to meet both national and international standards appropriate for their intended use. Strict regulatory requirements must be met including those specified by US Food and Drug Administration (FDA) or UK Medicines and Healthcare Products Regulatory Authority (MHRA).
MEDVACON's auditing team offers Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) audit services helping our clients to ensure that all relevant regulatory requirements (FDA, NF, MHRA) are met. We provide auditing solutions for all types of pharmaceutical products such as active pharmaceutical ingredients (APIs), drug products, excipients, over-the-counter products, vaccines and vitamins. MEDVACON can add value to your business by helping you to achieve or maintain regulatory compliance for equipment, facilities, utilities, processes and process installations. Our global network of experienced auditors are available to conduct audits supporting the entire manufacturing supply chain.
Pharmaceuticals, Medical Devices and Biologics must be produced consistently and must be strictly controlled to meet both national and international standards appropriate for their intended use. Strict regulatory requirements must be met including those specified by US Food and Drug Administration (FDA) or UK Medicines and Healthcare Products Regulatory Authority (MHRA).
MEDVACON's auditing team offers Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) audit services helping our clients to ensure that all relevant regulatory requirements (FDA, NF, MHRA) are met. We provide auditing solutions for all types of pharmaceutical products such as active pharmaceutical ingredients (APIs), drug products, excipients, over-the-counter products, vaccines and vitamins. MEDVACON can add value to your business by helping you to achieve or maintain regulatory compliance for equipment, facilities, utilities, processes and process installations. Our global network of experienced auditors are available to conduct audits supporting the entire manufacturing supply chain.
Example Projects
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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 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
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 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. |
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.
Clinical IT Systems cGMP & Quality Audits
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.
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CSV & cGMP Audit of Hosting
Systems Provider 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.
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CSV & cGMP Audit of Hosting Systems Provider
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.
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.