Problem Statement

Client: A small Pharma company received a warning letter from the FDA related to compliance issues in manufacturing and quality. The company responded to the warning letter and submitted a CAPA plan (corrective and preventative action) to regulators.

Expertise And Solutions

The client company hired us to conduct an assessment of their manufacturing and quality operations to identify compliance risks. PJI Biotech conducted the baseline compliance assessment and identified the compliance issues. All the compliance issues were risk-ranked and prioritized based on the risks. After risk ranking, a remediation plan was developed. The baseline assessment and remediation plan were reviewed with site management. After reviewing the assessment and remediation plan, the site management asked PJI Biotech to help with remediation.

PJI Biotech developed the required policies, procedures, and other required documents, and harmonized them with other sites of the company. PJI Biotech worked with Site management to facilitate implementation. The project was completed within 4 months.

Results

As a result, the client was able to complete the assessment and remediation within 4 months to ensure all FDA commitments were completed in a timely manner.

Feedback

The company’s leadership team was pleased with the quality support. We requested feedback from the client and the following feedback was received from the Head of Site Quality and the Head of North American Operations.

“I would highly recommend Dipti Gulati to any firm in the Pharmaceutical Industry seeking timely insights and guidance from a seasoned quality professional. Dipti facilitated the development of a strong quality foundation and our ability to move our project steadily forward. Our pleasure, Dipti. We really appreciate your contributions to our project!”