GxP Central places a premium on the importance of continuous compliance monitoring to ensure that your efforts are both current and effective. Our consultants possess extensive domestic (US) and global experience and can cover the entire supply chain from raw materials to finished products.

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• Laboratory evaluation (personnel training and records, materials, experimental or analytical documentation, etc.)
• Laboratory facilities (inspection of sample collection, preparation and storage procedures, analytical procedures and raw data audit, QA documentation audit, etc.)
• Review SOPs for compliance with international standards
• Records, reports and record/sample retention
• Assessment of laboratories, records, facilities, test articles, test systems, facilities, chain of custody
• for compliance with GLP regulations

• Conduct specialized GCP auditing focusing on the issues associated with Phase I -III facilities
• Provide training and support SOP development associated with the current phase of development
• Assess compliance with FDA/EU regulations and ICH guidelines
• Evaluate the databases used to track SAEs and IND Safety Reports
• Review procedures for site visits and associated documents, such as monitoring reports and logs
• Review the content of SOPs to ensure procedures and systems used are in compliance with applicable guidelines and regulations
• Evaluate medical laboratories used to support clinical trials

Audits of Sites, Suppliers, and Supporting laboratories

• Audits appropriate for clinical trial and marketed products
• Quality Systems
• Validation
• Remediation
• FDA mock audits to help prepare for an FDA inspection that mimics the FDA GMP inspection process and provide an unbiased assessment of readiness for an actual FDA inspection
• FDA prior approval inspection audits to evaluate the preparedness of manufacturing facilities for regulatory inspections and conducting gap analyses or internal GMP audits to identify problem areas in quality system complaint handling, design control, corrective action, and manufacturing processes
• Gap analyses to determine current compliance with FDA regulations specific to determine compliance with current regulations

SOPs are written processes that describe in detail how to perform a work task-specific to your operations. Documenting standards properly allows businesses to comply with regulatory and quality standards, train more effectively, and enable a culture of continuous improvement. GxP Central provides

Areas of expertise across drugs, biologics, devices, diagnostics, nutraceuticals, dietary supplements, food, combo products, compounding pharmacies, and radio-pharma include:

Clinical—21 CFR Parts 50, 54, 56, 312, 314, 361, 14155

Manufacturing—21 CFR Parts 210, 211, 111, 820, 600, 601, 610

Non-Clinical—21 CFR Part 58

Electronic Records/Signatures—21 CFR Part 11

ISO—13485, 14155, 14971, 22716, 9000s, 62304, 15189, 17025

ICH—Q7A, E6, E2A

Compounding Pharmacy—USP 797

European Directives—2001/20/EC, 2005/28/EC

Canadian Medical Device Regulations— SOR-98-282

• Training start-ups new to the regulated industry about validation, Part 11, and data integrity obligations
• Conducting  gap analyses of your systems against regulatory requirements (e.g., Part 11), and offering advice on addressing critical priorities
• Serve as a “sounding board” for Adhoc compliance questions within an organization
• Developing practical, customized, and appropriate approaches to your computer system validation (CSV) efforts and documentation
• Reviewing and revising your vendor qualification SOPs
• Bridging the gap between IT, business units, QA, and vendors by addressing expectations and responsibilities
• Training staff on CSV concepts and Part 11 regulations as Validation projects are launched
• Identifying and assessing risks and compromise to data integrity as your data flow through your systems
• Writing validation plans and summary reports for your systems
• Identifying system relevance, vendor risk, and interpret audit findings
• Providing  validation document templates to ensure your processes are uncompromisingly efficient and repeatable
• Working with your business units to define and document requirements for new computer systems

• Document review and audit for example SOPs, Clinical GCP Protocols and Reports
• Audits of submission for ethical approval for GCP clinical trials
• Facility Inspections
• Critical Phase inspections of clinical studies
• System audits
• Sub-contractor audits (laboratories, archives, waste contractors)

Pharmaceutical manufacturers are required to carry out audits of their suppliers or have audits conducted on their behalf by appropriately qualified, experienced auditors. A GMP audit is a mission-critical component in the regulatory process that enables pharmaceutical manufacturers to meet the predetermined FDA compliance standards.

GxP Central frequently performs good manufacturing practice audits globally at a number of supplier sites to ensure GMP compliance. We carry out Full Site audits that focus on the facility’s quality management systems and cover a large number of products.

Pharmaceuticals/Biologics: Our approach to cGMP quality system implementation for biologic and pharmaceutical manufacturers (21 CFR Part 210 and 211) complies with FDA’s Compliance Program 7356.02.-A System Based Inspection of Drugs and focuses on the proper implementation and sustainability between the following six systems:

Design of Quality Systems for:

• Production
• Facilities and Equipment
• Laboratory controls
• Materials
• Packaging

• Policies, Standards, SOP Preparation, and/or Optimization
• Batch Record Review
• Remediation Project Management
• Quality Systems Development, Assessment, Remediation
• Root Cause Investigations and Corrective Action/Preventive Action (CAPA) Remediation
• Third-party GMP and GLP Compliance Auditing
• Mock FDA/International Regulatory Agency Inspections & PAI Readiness
• Due Diligence Compliance Inspections, Audits and Assistance
• FDA Actions (483 Observations, Warning Letters, Consent Decrees) Remediation
• Data Integrity Compliance
• Mergers & Acquisitions (M&A) regulatory integration

We work with our clients to develop scalable resource plans to support validation efforts throughout the project lifecycle. Whether it is drafting protocols to execution and compilation of data packs, our resources have you covered.

Validation Master Plans (VMPs)

• Design Qualification (DQ)
• Installation Qualification (IQ)

Operational Qualification (OQ)

• Performance Qualification (PQ