Audit Preparation

Biopharma Audit Preparation begins with implementing and maintaining quality systems which are 21 CFR part 11 compliant and essential components of any biopharmaceutical enterprise. Well-defined quality control measures appropriately administered in all processes and operations ensure tasks are completed at the highest standards to meet all compliance and regulatory requirements. Therefore, when an audit is imminent, your biopharmaceutical operation will benefit by demonstrating the business’s ability to drive compliance while showcasing full control of processes resulting in successful and stress-free audits.

BioPharma Consulting Group Audit Support

BioPharma Consulting Group (BCG) will ensure that all personnel are aware of the requirements for conducting in-house, client and regulatory audits. At BCG, we have worked with multiple regulatory agencies including, FDA, EMA, Japan, Singapore (HSA), Turkey and Brazil. BCG consultants have extensive experience in handling a variety of audits such as General, Data Integrity, Pre-Approval Inspections (PAI’s), GMP Manufacturing Certification, and Drug Product Market Distribution. Our consultants have served in different roles and responsibilities including, Front Room, Back Room, Leading Laboratory Walkthroughs and Responding to Observations.

Audit Preparation Should Include:

• Frequent Gemba walkthroughs for laboratories, manufacturing facilities and other departments.
• Preliminary in-house inspections by department personnel and leadership teams.
• Performing Mock Audits by cross-functional teams.
• Reviewing employee training records, safety protocols and risk assessments.
• Manage cleanliness and proper hygiene throughout facility and implement effective Environmental Monitoring programs.
• Ensuring all Data Integrity and Security are in place for all processes including audit trail review.
• Confirm quick response times to auditor documentation requests such as training records, validation packages, SOP’s and quality records.

To best prepare for an audit, a company should implement tasks from the list above and to use other tools and platforms as necessary with due diligence in following all regulatory standards and guidelines in any step or process. Contact us to discuss how to ensure that your company is proactive in meeting all compliance and integrity expectations.