A quality system is a set of written policies, processes, procedures, and defined responsibilities that an organization must implement to assure that the quality attributes of a finished drug product are consistently met.  Let our experts in Quality Assurance and Regulatory Affairs develop your quality management system to comply with regulatory requirements, mitigate the cost of poor quality, and improve patient outcomes.

Cleaning validation is the process of ensuring that the cleaning procedures for manufacturing equipment effectively prevent product contamination. Therefore, it is essential to document cleaning validation thoroughly to demonstrate compliance with Current Good Manufacturing Practice (CGMP) for finished pharmaceuticals. Our experts have vast experience in developing cleaning validation protocols that meet both regulatory standards and client expectations.

Testing the effectiveness of disinfectants is crucial to ensure that the agents used in sterile manufacturing areas can successfully eliminate potential contaminants from surfaces.

Our team of experts has extensive experience in developing protocols and performing DET on a number of surfaces to meet both regulatory requirements and client expectations.

A due diligence audit is the assessment of a potential investment that seeks to identify the facility, operational, personnel, or compliance issues prior to proceeding with a transaction.  If you are looking to purchase a compounding pharmacy or a manufacturing facility, contact our consulting team to ensure that you are equipped with the information to support your decision-making process.  

Eagle can develop Environmental Monitoring Programs consistent with CGMP and USP requirements. Environmental monitoring (EM) is a key element in ensuring that aseptic processing areas are maintained in an adequate state of control.

If you need help with your environmental monitoring program development, our team has the expertise you require. We offer an initial consultation to guide and support you with your regulatory needs. Contact us for more information.

We understand how important it is for your equipment to function properly. Your instruments play a crucial role in maintaining the quality of your products and the safety of your employees. To guarantee that your equipment is functioning optimally, it is recommended that most equipment and instruments be regularly inspected, calibrated, and checked to ensure that it is performing as expected. Our engineers at Eagles are dedicated to ensuring that your systems are performing at their best. Learn More

Our engineering team will guide you through the building design and construction process, whether it be at startup or transition, to ensure that your facility is in compliance with the standards that govern your operations, including: 

• Current Good Manufacturing Practice (CGMP)
• USP <795> Pharmaceutical Compounding – Nonsterile Preparations 
• USP <797> Pharmaceutical Compounding – Sterile Preparations
• USP <800> Hazardous Drugs – Handling in the Healthcare Settings 

We can assist you in determining the optimal layout of your space to maximize efficiency and workflow all while keeping growth in mind. Learn More

A gap analysis/third-party audit is a comparison between your current compliance status and the regulatory requirements that govern your operation.  Our Quality Assurance and Regulatory Affairs Team will review and assess your systems, processes, and documents to identify the gaps in compliance, evaluate the risk of non-compliance, and assist in remediation to ensure that your organization is inspection ready. Learn More

Appropriate responses after FDA or State Board of Pharmacy inspections are critical to the future of your organization.  Let our consulting team manage the regulatory response, suggest remediation activities, and support you through the development and implementation of Corrective and Preventive Action (CAPA) plans, to ensure that your organization has the best chance for success. Learn More (Video)

Operating procedures must be well-defined and specific to your organization. Schedule an on-site visit with Eagle so that a member of our consulting team can visit your facility, assess your current processes, and create written procedures in accordance with the regulatory requirements governing your organization, ensuring that all members of your team understand how to implement and execute your written procedures.

We provide services that help meet the USP <800> requirements for facility and equipment compliance. Our services include certifying Containment Primary Engineering Controls (C-PECs) and Containment Secondary Engineering Controls (C-SECs), as well as conducting thorough reviews of your facility design and workflow. Our environmental quality and control (EQC) program has the necessary tools to detect hazardous drug residue on surfaces and monitor those trends continuously. Our top priority is maintaining the highest levels of quality assurance and control to ensure maximum safety and compliance. Learn More