Business Imperatives

  • A leading pharmaceutical company based in the UK secured Freyr's services to audit their site's GMP (Good Manufacturing Practice) function, procedures, and documentation. 
  • They approached Freyr as they did not have in-house expertise with GMP requirements in compliance. 

Objectives

Support was required for audit service for the client site's GMP function, procedures, and documentation such as the manufacturing facility, quality function, testing activities, storage facility, labeling and packaging systems, equipment & facility systems, and documentation practices in the UK region.

Problem Statement

  • There had been a lack of in-house expertise with GMP requirements in compliance with MHRA (Medicines & Healthcare Products Regulatory Agency) rules. 
  • The audit was expected to be completed in a short time, which also entailed multiple visits to the client's location and auditing the facility in compliance with MHRA rules. 
  • There had been a challenge in obtaining information, papers, and records from multiple teams in line with the audit agenda and timetable. 

Freyr Solutions and Services

Freyr Solutions and Services
  • Freyr performed gap analysis and reviewed QMS documents and provided necessary corrections & suggestions. 
  • Pre-audit checklists were customized and sent to the auditee to understand the facility, organization structure & determine the scope of the audit. 
  • Conducted GMP audit of the facility for three days. 
  • A draft of the audit report was generated within 1 week after the audit. 
  • Identified and reported observations in the respective functions of the facility. 
  • Gap Analysis: Compared existing processes, procedures, and documentation against the requirements outlined in relevant standards or regulations. 
  • Document Review: Gathered all relevant QMS documents, including policies, procedures, work instructions, forms, templates, and records. 
  • Verification and Validation: Validated the effectiveness of updated processes and documentation through audits, reviews, and performance metrics. 
  • Documentation and Reporting: Reviewed process to prepare reports summarizing the results and recommendations for management review and approval. 
  • 2 Weeks Turnaround time for Planning, execution & audit report completed. 
  • Achieved 100% GDP compliance, adhering strictly to all the guidelines.

Successfully completed an audit service for the client's site to enhance compliance and quality in their manufacturing processes, procedures, and facilities. This ensures they meet Regulatory standards and industry best practices.