Services
Providing Everything You Need
Audits
In addition to meeting regulatory requirements, audits provide an independent evaluation of processes and procedures to determine compliance with established specifications, processes requirement, and contractual agreements.
Audits can be conducted throughout the complete manufacturing process. From the development phase, component and consumable manufacturing, kit assembly, drug substance or drug product manufacturing, analytical or microbial testing (in-process or release), product stability activities, compound pharmacies, warehouse and distribution services, to sales sample management, we have the process covered.
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Types of audits, both internal and external (supplier, vendor, or contract manufacturing organization) include:
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Qualification (Due Diligence)
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Routine (Surveillance)
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For Cause (Targeted)
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Pre-approval Inspection (Mock)
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Consulting
Consulting services allow for a fresh look at a process or system. Walk throughs of new facilities, facility expansions, or facility redesign allows for feedback regarding process, product, and personnel flow. Gap analysis of systems, procedures, or process focus on identifying improvements and providing recommendations to align with current industry standards.
Training
Training is key to ensure current industry thinking and trends are communicated throughout your team. General GMP training for non-GMP personnel allows an introduction to the importance of GMP requirements and activities. GMP industry trend training provides a basis for upcoming changes or new regulations, and includes discussion of industry standard interpretation and recommendations how to apply the learning. Pre-approval inspection (mock inspection training) provides situation training and feedback specific to inspection conduct, interview techniques, and presentations.