Auditing is a crucial activity that ensures that manufacturing processes and facilities comply with the quality standards set by regulatory authorities. This comprehensive inspection of a pharmaceutical production company or supplier is conducted to assess if an organization is compliant with GMP regulations and industry standards. Audits help identify areas for improvement on GxP compliance and provide guidance on how to become compliant.
The audit verifies that manufacturing control systems are under a state of control and that production processes adhere to quality control guidelines. This permits timely correction of any potential problems identified. The ultimate goal of an audit is to ensure that products are safe for use, and produced consistently, so they meet customer expectations (e.g., the same product should look and operate the same every time).
Our Approach
RegDev approaches auditing in the same way as a government body/health authority’s approach in assessing a company or supplier’s critical areas. Our consultants provide an objective assessment of a given company/supplier’s overall system to ensure the company/supplier is compliant with the current regulations, industry standards, company or supplier’s internal procedures, and contractual agreements between the company/supplier and the client.
ASSESSING CRITICAL AREAS
VENDOR QUALIFICATION
OBJECTIVE EVALUATION
REGULATORY COMPLIANCE
REDUCE DELAYS
INFORMED DECISIONS
PRODUCT PHASE MATCHING
RegDev’s goal is to ensure that the client’s product phase is matched with the appropriate regulatory requirements to allow GMP and product to evolve together, from development to commercialization at the appropriate level. This approach allows clients to forgo implementing systems or utilizing contract services’ systems which are overly stringent or out of compliance, and to make an informed decision on whether to embark on activities with a given company/supplier.
MITIGATE RISK, EXPLORE OPTIONS
Clients can utilize audit data to determine if a company/supplier is suitable for their development and manufacturing needs. Additionally, clients can identify and mitigate any potential risk from the audit results associated with a given company/supplier. The audit data allows clients to explore different service or material options upfront, without heavily investing time and resources on a company/supplier which may not meet the client’s standards or requirements.
NAVIGATING REGULATORY REQUIREMENTS
Audits provide insight into the company/supplier’s systems and can identify any potential system deficiencies with applicable corresponding corrective actions. Understanding the company/supplier’s systems can help clients navigate through different regulatory requirements and avoid or reduce delays in product approvals.
Testimonial
“All auditors were of the highest caliber. The observations helped us establish and improve our quality managements systems. I highly recommend RegDev team!!”
