ProPharma specializes in delivering comprehensive current Good Manufacturing Practice (cGMP) Audits and GMP Consulting services, designed to ensure compliance with regulatory standards and optimize manufacturing processes. With extensive worldwide expertise in the pharmaceutical, biotechnology, medical device, advanced therapy, and other healthcare industries, our consulting experts are committed to helping our clients maintain the highest levels of compliance, quality, and efficiency.
Our GxP compliance team supports a complete suite of cGMP consulting options ranging from proactive to reactive needs.
ProPharma’s Global Auditing Program has conducted 1,000s of Audits for hundreds of global companies, across all GxP’s and phases. With offices and quality & compliance consultants located all over the world, ProPharma offers the availability to execute audits in different GxP areas on a global basis with diverse language skills, creating efficiencies in both time and money. Our large team of qualified auditors have a breadth of expertise across the entire development and regulatory spectrum (GMP, GCP, GLP, GCLP, GPV, ISO-13485, CSV, Data Integrity, etc.).
Our Audit Coordinators make your role easier, they provide facilitation and management of audit logistics, periodic progress meetings, timelines, and completion of deliverables between client/sponsor, auditor, and auditee.
The ProPharma Coordination team is connected to our network of Subject Matter Expert Compliance Consultants who provide technical support and guidance for compliance processes, peer review of deliverables and outputs as well as access to the entire catalogue of ProPharma’s services, forming our Global Auditing Team.
Our Global Auditing Team brings unparalleled collaboration, consultation, and right-sized compliance options to your GMP audit needs with a broad compliance reach.
We follow standardized practices relevant to local Health Authorities applicable to the individual client, sponsor, and/or auditee or are flexible to design a focused or for-cause audit specific to a direct client compliance need.
Our GMP Auditing service was developed, and the process has been optimized over the years, which our customers find to be compliant, thorough, and efficient.
Thorough preparation including document review and audit plan development. Following client provided procedures or through ProPharma’s established process.
Evaluation of quality control and assurance processes.
Examination of manufacturing practices, process controls, and batch documentation.
Inspection of physical facilities and equipment maintenance programs.
Assessment of staff qualifications, training programs, and competency records.
Review of supplier qualification processes and material handling procedures.
ProPharma’s cGMP consulting experts deliver tailored Quality System compliance solutions to our clients. We specialize in guiding pharmaceutical, device, biologics, and targeted therapies companies through the complexities of health authority requirements, ensuring that their processes meet stringent quality expectations. With our expert team of compliance consultants, you can confidently navigate the evolving landscape of GMP regulations, ultimately enhancing quality, safety, and efficacy.
FDA Action (483 Observations, Warning Letters, Consent Decrees) Remediation
Our Consulting team is composed of seasoned professionals with years of experience in GMP environments and best practices. Coupling deep understanding of the expectations and challenges of manufacturing in regulated environments, we ensure our clients receive the highest level of service and outcome.
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