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Quality Audits

Quality Audits you can trust.  We perform GCP, GMP, and GLP quality audits around the world.  Our team of former FDA Inspectors and Industry Experts conduct objective audits in-line with government regulations, industry expectations, and our client’s own internal requirements. Similarly, Quality audits are often conducted in preparation for FDA inspections or product approvals.  Clients benefit from our extensive experience, allowing them to reduce costs and focus internal resources on other assignments. 

What can I expect in a Quality Audit?

Quality Audit Process Flow:

  • A formal Audit Agenda is issued.
  • The on-site (or remote) audit is conducted by the lead auditor + optional attendees.
  • An Audit Closing Meeting is held with the site.
  • A Final Audit Report with observations and recommended corrective actions is issued.
  • We review audit responses and/or corrective actions. 
  • Audit closure (upon request.)

Quality Audit Review:

  • Review of current practices in compliance with FDA regulations and industry standards.
  • Review of the Quality Manual or Site Quality Plan.
  • Review of current procedures and work instructions.
  • Review of quality records and raw data.
  • Site tour and product evaluation.
  • Interviews with Subject-Matter Experts (SMEs) and area leads.
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Do you offer other kinds of audits?

For Cause & Directed Audits

For Cause or Directed Audits consist of the following:

  • Contains all of the items above conducted by an auditor with technical expertise in the specific areas of concern
  • The audit agenda focuses on a specific subject matter or area of concern
  • The audit consists of an in-depth review of technical data (Ex: validation documentation, design history file (DHF), clinical data, trial master file (TMF) review, analytical test data, batch record review, microbial testing data, etc)
  • During a For Cause Audit we provide technical expertise with a targeted scope

Supplier Audits

We audit vendors so you don’t have to. Our clients experience a reduction in overall cost, flexibility in audit scheduling, and expedited audit documentation.

We routinely perform the following supplier audits:

  • Qualification audits for API manufacturers
  • Contract Manufacturing Operations (CMOs/ CSPs)
  • Third party laboratories
  • Component manufacturers, including molded components
  • Software and hardware manufacturers and developers
  • Packaging companies
  • Distribution centers
  • Clinical kitting facilities
  • Clinical sites
  • Contract Research Organizations (CROs)

How we can help:

Exemplar Compliance conducts and internal and external quality audits, quickly and efficiently. Our seasoned auditors are trained to look for critical gaps that may impact your process. We can provide a full set of audit documentation or use the template that aligns with your procedures.  

When do you get a quality audit?

Quality audits are generally conducted for critical suppliers, when a change has been made to a critical supplier or on a periodic basis. Internal quality audits are generally conducted annually to ensure that the quality system and supporting functions are performing as intended. Whenever you perform a quality audit it is important to follow your company’s internal procedures.

Our former FDA and industry experts have an average of 25 years of experience.

Some of Our Work

Internal Audit

Internal Quality Audit for a large device manufacturer

Internal Audits

We performed a series of internal quality system audits for a manufacturer of radiology and healthcare devices. The manufacturing and distribution sites were located in the US and across Europe. During these audits we were able to evaluate the functionality of the local quality system as well as the corporate quality SOPs. Audit reports were prepared for each site with recommended corrective actions. Not only were the required quality audits conducted but we were able to make the existing processes more efficient.

CMO Audit

Vendor audits for a virtual manufacturing company of a combo product

CMO Audit

We conducted audits for a “virtual manufacturer” of drug-device combination products. We call them a virtual manufacturer because the company is based in a small office while all manufacturing, storage, and testing activities take place at contract manufacturing facilities (CMOs). We helped our client by auditing the CMO of their sterile injectable solution, syringe manufacturer, device manufacturer, and API manufacturer. Reports were compiled under the client’s quality system and we worked with the client and their CMOs to resolve discrepancies.

FDA Mock Inspection

Quality Audit + FDA Readiness for a biologic-device combo product

FDA Mock Inspection

In preparation for an upcoming FDA inspection we performed a mock FDA inspection for one of our clients in California. We were on-site for several days interviewing employees, touring the facility, and reviewing quality records. Our auditors arrived on site as mock (pretend) FDA investigators and did not break character until after the closing meeting. We completed a thorough quality audit and got the site ready for the FDA. People were able to practice in a safe environment and ask questions about their subject matter.

Contact us today for a free initial consultation.

We would love to hear about your project.

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