QualPharm employs a comprehensive and integrated approach to Quality System development and remediation.

 

1. Quality System/Document Assessment

A review of your quality system, processes and supporting documentation. This helps in the initial determination and identification of compliance gaps and improvement opportunities

2. On-Site Assessment/Audit

The on-site assessment can be focused on the level of compliance found versus the compliance necessary for the current and subsequent stages of drug development and manufacturing. The assessment will focus on Quality Systems and the responsibilities of the Quality Unit to ensure regulatory compliance and maintain patient safety.

3. Assessment Report

Based on the audit findings, an audit report will be issued which outlines specific compliance concerns and quality system deficiencies. If requested, the report will also present a high level action plan for remediation.

4. Remediation and Continuous Improvement Plan

Develop a remediation/continuous improvement plan that focuses on the current state of quality systems and includes:
– Risk assessment of current practices
– Impact, if any, to the quality of produced and distributed product
– Immediate stop-gap measures allowing continued manufacturing
– Long-term corrective actions and effectiveness evaluation

5. Quality System Development and/or Improvement

QualPharm will work with your company in whatever capacity you choose to improve or implement these processes.

6. Document Preparation

QualPharm can write complete SOPs or revise current documents to fit the needs of your company and to maintain your compliance and control systems.

7. Implementation

QualPharm will help you in implementing these systems in a timely, logical, and integrated manner.

8. Training

QualPharm will train on CGMPs, self-inspections, inspection readiness, as well as specific compliance related topics.