Quality Systems Audits / Gap Assessments
What Are Quality System Audits / GAP Assessments?
Pharmaceuticals, medical devices and biologics must be consistently produced and strictly controlled to meet the domestic and international standards applicable to their intended use. Specifically, these include regulations enforced by the US Food and Drug Administration (FDA) and/or the UK Medicines and Healthcare Products Regulatory Authority (MHRA). Adhering to these requirements is critical for protecting patients and minimizing the possibility of regulatory action. Determining whether potential gaps are isolated or systemic, and then identifying targeted, effective, and sustainable controls is key to reducing unnecessary risk.
MEDVACON’s auditing team offers Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) audit services to identify potential system, process and compliance gaps and then assess their potential level of risk. We provide auditing solutions for pharmaceutical ingredients (APIs), drug products, excipients, over-the-counter products, vaccines, and vitamins. MEDVACON provides additional value by evaluating both the individual components and their connections across your entire Quality System, including processes, equipment, facilities, utilities, and system installations. Our global network of experienced auditors is available to conduct audits supporting the entire manufacturing supply chain.
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.
Example Projects:
Quality GAP Assessment – Kitting
MEDVACON was engaged by the client as part of the company’s continuing dedication to excellence. The client identified the need to engage MEDVACON external auditors to support the internal audit/ gap assessment of the quality/compliance group with the goal of achieving and maintaining a strong GMP compliant organization. MEDVACON provided an expert employee consultant to evaluate current organizational GMP status and identify existing gaps. MEDVACON worked cooperatively with internal client principals to perform a high-level audit/ assessment of critical quality functions within the Quality and Compliance department. The GAP Assessment was successfully completed and MEDVACON continued to provide services to the client.
Manufacturing GAP Assessment - Pharmaceutical Manufacturer
MEDVACON was engaged to conduct an in-depth Quality Assessment for manufacturing of Phase II/III drug substance batches, specifically relating to the ability to manufacture and test and release such batches. MEDVACON conducted the Quality GAP Assessment and issued a report. MEDVACON was retained by the client to conduct additional work.
Quality System Assessment - Pharmaceutical Manufacturer
We were engaged by a pharmaceutical client to assess their entire quality system as a result of an FDA Warning letter. A team of resources was brought in to assess the existing quality system and ultimately to develop and implement a new Quality System current with FDA requirements. This new system impacted several areas of the operation including Manufacturing, Packaging, Laboratory, Procurement, Information Technology, to name a few. Upon approval of the newly developed Master Validation Plan each of the respective areas systems and equipment was assessed against the new standards. This resulted in dozens of systems requiring new validation and dozens requiring revalidation to new standard. The remediation team of over seventy consultants remained on task for approximately eighteen months and ultimately was successful in having the Warning Letter lifted.
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