Ensure tasks are completed at the highest standards to meet all compliance and regulatory requirements.
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.
Biotech & Pharmaceutical Consulting Services
Our Quality Assurance services focus on improving quality, integrity and compliance by providing certainty of the product and data. Guaranteeing effectiveness and efficiency as per client expectations and regulatory requirements with regard to patient safety.
BCG will manage client projects with technical competencies focused on quality design efficiency through customized strategies to meet all company goals and produce completed projects compliant to objectives and timelines.