case study

Compliance Assurance Engagement Leads to Passed FDA Inspection and Improved Workflow

A pharmaceutical company engaged RCA to prepare the company for an FDA Audit. The company implemented the recommended changes and passed the inspection.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Compliance Assurance Engagement Leads to Passed FDA Inspection and Improved Workflow

Background

Qualitest, a leading developer and manufacturer of affordable, high-quality generic pharmaceuticals, launched a compliance strategy to prepared for upcoming FDA inspections.

To protect public safety, the U.S. Food and Drug Administration (FDA) routines audits and assesses companies that manufacture and package drugs. Qualitest wanted to better understand the unique conditions that violate FDA regulations. The leadership team was not in fear of receiving a FDA warning letter. However, being proactive to stay in compliance was the root focus of the strategy.

RCA helped prepare our teams for FDA inspection. Bringing in a different set of eyes helped us improve and helped to successfully ready our facilities.

Solution

Qualitest engaged Regulatory Compliance Associates® Inc. (RCA) to prepare the company in advance of an FDA Audit. RCA reviewed over 170 investigations relating to Qualitest operations to suggest improvements and identify areas of risk.

RCA conducted a mock audit to both ensure the compliance of the client and to maintain their readiness for the actual FDA inspection. RCA’s experienced team of ASQ-CQA and RABQSA certified auditors was available to perform a range of internal audit services, including:

  • Supplier
  • API
  • Contact Manufactures (CMO)
  • Internal
  • Quality Systems
  • Baseline
  • Verification
  • Clinical (CRO) and Clinical Manufacturing
  • Data Integrity
  • 503A & 503B
  • Combination Products

By working efficiently and by tapping into scheduled downtime, RCA was able to complete the project in three months.

Result

Qualitest implemented the recommended changes, including company-wide training, and received no observations during the next FDA inspection.

Background

Qualitest, a leading developer and manufacturer of affordable, high-quality generic pharmaceuticals, launched a compliance strategy to prepared for upcoming FDA inspections.

To protect public safety, the U.S. Food and Drug Administration (FDA) routines audits and assesses companies that manufacture and package drugs. Qualitest wanted to better understand the unique conditions that violate FDA regulations. The leadership team was not in fear of receiving a FDA warning letter. However, being proactive to stay in compliance was the root focus of the strategy.

RCA helped prepare our teams for FDA inspection. Bringing in a different set of eyes helped us improve and helped to successfully ready our facilities.

Solution

Qualitest engaged Regulatory Compliance Associates® Inc. (RCA) to prepare the company in advance of an FDA Audit. RCA reviewed over 170 investigations relating to Qualitest operations to suggest improvements and identify areas of risk.

RCA conducted a mock audit to both ensure the compliance of the client and to maintain their readiness for the actual FDA inspection. RCA’s experienced team of ASQ-CQA and RABQSA certified auditors was available to perform a range of internal audit services, including:

  • Supplier
  • API
  • Contact Manufactures (CMO)
  • Internal
  • Quality Systems
  • Baseline
  • Verification
  • Clinical (CRO) and Clinical Manufacturing
  • Data Integrity
  • 503A & 503B
  • Combination Products

By working efficiently and by tapping into scheduled downtime, RCA was able to complete the project in three months.

Result

Qualitest implemented the recommended changes, including company-wide training, and received no observations during the next FDA inspection.

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