Navigating the complex web of pharmaceutical turnkey solutions is one of the most daunting challenges in building a new manufacturing facility. A single compliance misstep can lead to costly delays, failed inspections, or even prevent a facility from operating altogether. Iven Pharmatech has built its reputation on a proactive and systematic approach to compliance, ensuring that every turnkey project not only meets but exceeds the rigorous standards set by global health authorities, transforming regulatory hurdles into a structured pathway to success.
Building on a Foundation of Regulatory Intelligence
The journey to compliance begins long before construction, rooted in Iven Pharmatech’s deep reservoir of regulatory intelligence. Their team maintains an up-to-the-minute understanding of the evolving requirements from key agencies like the FDA, EMA, and other international bodies. This knowledge is not static; it is actively applied during the initial concept and design phases. By anticipating regulatory expectations from the very start, they ensure that the facility's blueprint is inherently compliant, eliminating the need for costly redesigns and setting a solid foundation for the entire project.
Implementing a Proactive Quality by Design Framework
Compliance is seamlessly woven into the project's fabric through a Quality by Design (QbD) methodology. This means that quality and regulatory considerations are not afterthoughts but are integral to every decision. During design reviews, the team identifies Critical Process Parameters (CPPs) and links them directly to patient-impacting Critical Quality Attributes (CQAs). This scientific, risk-based approach demonstrates to regulators that the facility is designed to consistently produce a quality product, moving beyond mere checklist compliance to a state of validated and assured performance.
Meticulous Documentation and Audit-Ready Practices
From day one, Iven Pharmatech operates with an "always audit-ready" mindset. They generate and manage a comprehensive suite of documents, including design specifications, standard operating procedures (SOPs), and quality control protocols. This meticulous documentation creates a transparent and verifiable narrative of the project, proving that every step was executed according to plan and in full compliance with cGMP. This disciplined approach turns the often-stressful regulatory audit into a straightforward demonstration of a well-executed process.
Rigorous Supplier Qualification and Material Control
A compliant facility is only as reliable as its components. Iven Pharmatech exercises stringent control over its supply chain, implementing a formal vendor qualification program. Every key supplier, from equipment manufacturers to material vendors, is thoroughly vetted to ensure their products and services meet the required regulatory standards. Certificates of Analysis (CoA) and material traceability are maintained for critical components, ensuring that every element integrated into the facility contributes to its overall compliance and integrity.
Mastering the Validation Lifecycle
The ultimate proof of compliance lies in the validation process. Iven Pharmatech manages this critical phase with precision, executing a structured sequence of Qualification protocols: Installation (IQ), Operational (OQ), and Performance (PQ). The IQ verifies equipment is installed correctly, the OQ confirms it operates within specified limits, and the PQ demonstrates that the entire process can consistently produce a product meeting its quality attributes. This data-driven evidence forms the undeniable proof of compliance required for regulatory approval.
Fostering a Culture of Continuous Compliance
Iven Pharmatech’s commitment extends beyond project handover. They work to instill a culture of continuous compliance within the client’s own organization. This is achieved through comprehensive knowledge transfer, detailed training on new systems and SOPs, and establishing clear quality management processes. By empowering the client’s team with the understanding and tools to maintain the validated state, they ensure the facility remains in continuous compliance, ready to adapt to future regulatory changes and uphold the highest standards of quality and safety for years to come.
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