Biotech GxP Compliance Audits and Consulting

GxP Regulatory Compliance Support

​

• FDA, EMA, and ICH Compliance Readiness:

  • Ensure compliance with FDA (21 CFR Parts 210, 211, 820, and 11) and EMA guidelines.

  • Align company processes with ICH Q7, Q9, Q10, and E6(R2) standards.

  • Assist with compliance to global standards like PIC/S and WHO GMP.

• Regulatory Submissions Assistance:

  • Prepare and review quality sections for IND, NDA, BLA, or MAA applications.

  • Assist in responding to health authority inquiries and inspection findings (e.g., FDA Form 483 or warning letters).

• Gap Analysis & Risk-Based Assessments:

  • Perform detailed gap assessments of existing systems against regulatory requirements.

  • Develop risk mitigation strategies using ICH Q9 principles to prioritize areas for improvement.

GxP Inspection Readiness & Audit Support

​

• Mock Audits and Inspections:

  • Simulate regulatory inspections for GMP/GCP sites, including FDA, EMA, or MHRA-style audits.

  • Assess processes for compliance risks and develop corrective action plans.

• Post-Inspection Support & CAPA:

  • Assist with inspection findings, such as FDA 483s, and create action plans to resolve compliance issues.

  • Support CAPA tracking to ensure timely resolution and effectiveness checks.

• Vendor Qualification & Oversight Audits:

  • Conduct audits of CROs, CMOs, CDMOs, and suppliers to ensure compliance with GMP and GCP.

  • Develop qualification plans for vendors and monitor their performance.​

GMP Consulting Services

Process Validation & Qualification

​

• Process & Equipment Validation:

  • Support the development and execution of validation protocols (IQ, OQ, PQ) to confirm that processes perform consistently.

  • Perform cleaning validation to ensure that equipment cleaning procedures remove residues to acceptable levels.

• Product Quality Review (PQR):

  • Conduct annual product reviews to assess batch consistency, stability, and process deviations.

  • Identify trends in deviations or product complaints to implement preventive measures.

Lot Release and Quality Control Support

​

• Batch Record Review & Lot Release:

  • Review batch records for compliance with approved specifications and ensure any deviations are investigated and resolved.

  • Provide independent QA support to facilitate timely lot disposition for clinical or commercial use.

• Stability Program Management:

  • Develop stability protocols to ensure products remain within specification throughout their shelf life.

  • Monitor stability data to identify potential trends and prepare reports for regulatory submissions.

​​

Training & Continuous Improvement Services

​

• Customized Training Programs:

  • Develop specialized GMP/GCP training programs for employees, ensuring that everyone understands their role in maintaining compliance.

  • Provide ongoing training sessions on data integrity, CAPA management, and inspection readiness.

• Deviation and CAPA Management:

  • Implement root cause analysis tools (e.g., 5-Whys, Fishbone Diagrams) to identify the underlying causes of deviations.

  • Establish procedures to track CAPA effectiveness, preventing recurrence of issues.

• Continuous Improvement (Lean & Six Sigma):

  • Apply Lean principles to eliminate waste and improve efficiency in manufacturing and quality operations.

  • Use Six Sigma techniques to reduce variability and improve process quality, resulting in fewer deviations.

Quality Management System (QMS) Development & Optimization

​

• QMS Design & Implementation:

  • Build a tailored QMS aligned with ICH Q10 principles, ensuring it covers:

    • Deviation management

    • Corrective and preventive actions (CAPA)

    • Change control and document management

  • Create SOPs to standardize processes like material handling, product release, and environmental monitoring.

• Change Control and Continuous Monitoring:

  • Develop procedures to assess the risks of process changes, such as equipment upgrades or material switches.

  • Implement systems for real-time monitoring of compliance metrics (deviations, complaints, non-conformances).

• Internal Audits & Monitoring Programs:

  • Design and execute a calendar of internal audits across departments (manufacturing, QC, QA, and clinical).

  • Track audit findings and corrective actions to ensure sustained compliance and continuous improvement.

GCP Consulting Services

Clinical Trial Oversight & Compliance

​

• GCP Site Audits and Monitoring:

  • Assess clinical trial sites for protocol adherence, patient safety, and GCP compliance.

  • Verify that investigators follow informed consent procedures and patient confidentiality requirements.

• Trial Master File (TMF) Audits:

  • Perform comprehensive TMF audits to confirm all essential clinical documentation is accurate and up-to-date.

  • Ensure that regulatory approvals, IRB submissions, and monitoring reports are well-documented.

• CRO and Vendor Management:

  • Develop qualification criteria for CROs, central labs, and other service providers.

  • Establish oversight programs to track vendor performance and ensure clinical trial quality.

Data Integrity & Digital Compliance

​

• Data Integrity Audits:

  • Evaluate data management practices for compliance with FDA’s 21 CFR Part 11 and EU Annex 11.

  • Identify gaps in electronic data management, including incomplete audit trails, improper access controls, and missing signatures.

• Digital System Validation (CSV):

  • Validate software systems used in the manufacturing and clinical processes (e.g., LIMS, ERP, SCADA).

  • Develop protocols to confirm that systems consistently capture accurate data and generate complete audit trails.

• Data Governance & Integrity Remediation Plans:

  • Create data integrity governance frameworks to ensure ALCOA+ principles are followed (Attributable, Legible, Contemporaneous, Original, Accurate, Complete).

  • Implement corrective actions for identified issues, including staff training and system reconfigurations.

​​

External Manufacturing & Quality Oversight

​

• CMO/CDMO Oversight:

  • Monitor external manufacturing partners to ensure they meet regulatory and quality expectations.

  • Conduct regular audits and provide on-site quality oversight during critical production stages.

• Supplier Qualification & Management:

  • Develop supplier qualification programs to assess vendors’ capabilities and ensure they meet quality standards.

  • Monitor supplier performance through metrics like on-time delivery, deviation reports, and customer complaints.

  • Implement ongoing monitoring through regular audits, performance scorecards, and clear communication channels to maintain quality standards.