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.
Proactive ⇔ Reactive
Our GxP compliance team supports a complete suite of cGMP consulting options ranging from proactive to reactive needs.
Preventative
- GMP Vendor Qualification
- GMP and QMS Gap Analysis
- Mock PAI / BLI Readiness
- Internal GMP audit
- QMS Building / Revision
Maintenance
- Maintenance GMP vendor audit
- GMP Desktop / Checklist assessments
Remedial
- cGMP consulting services
- For-Cause GMP Audits
- Health Authority Response
- Observation, 483, Consent Decree support.
GxP Audit Experience
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.).
GMP Audit Coordination Team
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.
ProPharma's GMP Audit Strategies
With respect to GMP Audits
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.
ProPharma’s Standard Scope and Methodology
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.
Coordination & Preparation
- Coordination Setup
- Auditor Briefing Meeting
- Agenda/Audit Plan
Audit Execution
- On-site or Virtual
- Audit Conduct
- Close Out Meetings
Post Audit
- Report
- Follow-Up
- Remediation Support Available
Pre-Audit Planning
Thorough preparation including document review and audit plan development. Following client provided procedures or through ProPharma’s established process.
Key Areas of Focus During GMP Audits
Quality Management Systems
Evaluation of quality control and assurance processes.
Production Processes
Examination of manufacturing practices, process controls, and batch documentation.
Facility and Equipment
Inspection of physical facilities and equipment maintenance programs.
Personnel Training
Assessment of staff qualifications, training programs, and competency records.
Supply Chain Management
Review of supplier qualification processes and material handling procedures.
ProPharma’s GMP Consulting Services
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.
Consulting Services Offered
- Quality Compliance: Guidance on meeting FDA, EMA, MHRA, and other international health authority requirements.
- Quality System Development: Assistance in evaluating / assessing current stated and developing and implementing robust quality management systems.
- Remediation Support: Support in addressing regulatory findings, including CAPA (Corrective and Preventive Action) planning and implementation.
GMP Consulting Services
Quality Management Systems
- Implementation, Remediation, and Maintenance - EMEA/MHRA/FDA - Pharma and Medical Device / Diagnostics
- eQMS - Dot Compliance
Quality Assurance
- Market Importation Authorisation (MIA) holder QP/RP release
- Root Cause Investigations/Deviations & CAPA Planning & Execution
- Policy, SOP & Batch Record Review, Preparation &...
Pre-Approval Inspection and Auditing
- Third-party GxP Compliance Auditing
- Mock FDA/International Regulatory Agency Inspections & PAI Readiness
Remediation
FDA Action (483 Observations, Warning Letters, Consent Decrees) Remediation
Quality Control
- EM and QC Program Development, Analysis Testing, Method Validation
Additional GMP Audits & Consulting Services
- Clinical & Commercial Quality Services. Phase I - Phase IV
- Auditing Services PAI & GxP
- Commissioning, Qualification & Validation
- Compliance
- Product...
GMP Consulting Approach
- Assessment and Analysis: In-depth analysis of current practices and identification of improvement opportunities.
- Strategic Planning: Development of tailored strategies to enhance compliance and operational efficiency.
- Implementation Support: Hands-on assistance with the implementation of recommended changes and ongoing support to ensure sustained improvements.
- Project & Program Management: direction and monitoring of milestone deliverables and project progression:
- Performance Monitoring: Assistance with vendor management, compliance oversight, and auditing to monitor compliance.
Our GMP Auditing Expertise:
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.
Benefits of Partnering with Us
- Enhanced Compliance: Achieve and “right-sized” compliance with relevant GMP regulations aligned with your company’s unique quality processes and business requirements.
- Improved Efficiency: Optimize quality processes for better productivity and cost savings.
- Risk Mitigation: Identify and mitigate compliance risks to prevent costly regulatory actions.
- Knowledge Transfer: Empower your team with the knowledge and skills needed to sustain high standards of quality and compliance.
News & Insights
December 19, 2024
WHO Issues Guidance on Antibiotic Pollution Control
WHO issues guidance to control antibiotic pollution from manufacturing, addressing environmental and global health impacts of antimicrobial resistance.
December 18, 2024
Nonclinical Drug Development: FDA Recommendations for Confirming an Ames Positive Finding
Explore FDA's recommendations on follow-up testing for Ames-positive drugs to support first-in-human clinical trials. Learn how to navigate FDA regulations and ensuring successful product development.
December 17, 2024
Navigating Market Access & Reimbursement Strategy for Medical Devices in Europe
Explore the importance of market access and reimbursement strategies for medical devices and in vitro diagnostics (IVDs) in Europe. Learn how early planning and the new European HTAR can enhance the...
News & Insights
October 21, 2024
ProPharma Appoints Brian Tuttle as Chief Financial Officer
ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
October 9, 2024
ProPharma Receives 2024 CPHI Regulatory and Compliance Award
ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.
September 30, 2024
ProPharma Names Dawn Sherman Chief Executive Officer
Dawn Sherman rejoins ProPharma as CEO, bringing nearly 30 years of industry experience to lead the regulatory, clinical, and compliance services provider.
