Pharmaceutical GxP Compliance Audits and Consulting

Quality Management System (QMS) Services

QMS Design and Implementation
- Develop a risk-based quality management framework aligned with ICH Q10 guidelines.
- Incorporate integrated quality policies, procedures, and records across multiple functions (manufacturing, QC, supply chain).
- Use platforms such as Veeva, MasterControl, or SAP QMS to track and manage documentation.
Standard Operating Procedure (SOP) Development and Review
- Draft and revise SOPs to align with specific FDA/EMA guidance documents (e.g., 21 CFR Part 211).
- Ensure SOPs for deviations, batch production records, OOS (Out of Specification), and change control are clear and auditable.
Quality Risk Management (QRM)
- Use Failure Mode and Effect Analysis (FMEA) and Risk Priority Number (RPN) to rank risks.
- Implement risk-based decision-making during process validation and vendor qualification.

Internal GMP Audits
- Conduct periodic internal audits covering manufacturing processes, facilities, utilities, and cleaning validation.
- Audit areas such as raw material handling, batch manufacturing, environmental monitoring, and cleaning procedures.
External Supplier and Vendor Audits
- Perform GMP pre-qualification audits of CMOs, excipient suppliers, and packaging vendors.
- Assess vendor compliance with quality agreements, specifications, and regulatory filings (DMF, CEP).
Gap Analysis and Inspection Readiness
- Review site readiness for regulatory inspections (FDA, EMA, MHRA) by conducting mock audits.
- Address compliance gaps by implementing corrective action plans and providing inspection coaching to personnel.
Deviation Investigation & CAPA Management
- Investigate root causes of deviations using 5-Why, Fishbone Diagrams, and ensure deviations are closed within set timelines.
- Develop comprehensive CAPA plans with clear ownership, due dates, and effectiveness checks.

GLP Audits
- Audit QC and R&D laboratories for adherence to GLP guidelines (21 CFR Part 58).
- Review calibration and maintenance logs for equipment (e.g., HPLC, GC, Spectrophotometers).
Data Integrity Assessments
- Ensure compliance with ALCOA+ principles (Accurate, Legible, Contemporaneous, Original, Attributable) in documentation and records.
- Validate that electronic systems maintain secure, audit-trail enabled records.
Method Validation and Stability Studies Review
- Review analytical method validations for specificity, linearity, accuracy, precision, and robustness.
- Confirm that stability studies are designed per ICH Q1A (R2) to support shelf-life and labeling claims.

GDP Audits and Assessments
- Conduct GDP audits of warehouses, distribution centers, and wholesalers.
- Evaluate compliance with storage conditions, batch traceability, and document control requirements.
Temperature-Controlled Logistics Oversight
- Assess cold chain management for biologics and vaccines, ensuring compliance with validated temperature ranges (e.g., 2°C–8°C or -20°C).
- Monitor transportation data loggers for excursions and implement response procedures for deviations.
Recall Management and Product Traceability
- Design end-to-end recall management processes aligned with regulatory guidelines.
- Ensure traceability systems can track raw materials and product batches throughout the supply chain.

Regulatory Filings Support
- Assist with the preparation of Investigational New Drug (IND) and New Drug Application (NDA)submissions.
- Support with the review of Drug Master Files (DMFs) and response to FDA 483 observations.
Change Control Management
- Oversee change control processes for new equipment, processes, or materials, ensuring that changes are assessed for regulatory impact.
- Coordinate with cross-functional teams to implement changes while maintaining compliance.
Annual Product Quality Review (APQR)
- Prepare and review APQR reports to analyze product quality trends, deviations, and complaints over the year.
- Identify areas for improvement and present recommendations for continuous improvement.

GxP Training Programs
- Deliver targeted training sessions on GMP, GLP, and GDP tailored to manufacturing, QC, and warehouse personnel.
- Develop role-specific training curricula with regular competency assessments.
Continuous Improvement Initiatives
- Implement Lean and Six Sigma projects to reduce defects and improve manufacturing yield.
- Conduct Kaizen events to identify bottlenecks in manufacturing or QC processes.
Regulatory Inspection Handling Training
- Train employees on effective communication and document retrieval during audits.
- Simulate regulatory inspections to prepare staff for FDA or EMA interactions.

CSV Services
- Validate GMP-relevant systems such as LIMS (Laboratory Information Management System), ERP systems, and MES.
- Develop validation protocols (IQ, OQ, PQ) to ensure computerized systems function as intended.
Data Integrity Program Implementation
- Set up governance frameworks to ensure GMP data integrity, including access control, audit trails, and regular data reviews.
- Conduct periodic reviews to identify and mitigate potential data integrity breaches.

Quality Performance Indicators (KPIs)
- Define key metrics such as deviation closure rate, CAPA effectiveness, batch rejection rate, and audit finding closure time.
- Provide trend analysis and reports to track quality performance over time.
Audit Findings Closure and Compliance Tracking
- Develop a tracker system to monitor open audit findings, CAPA progress, and ensure timely closure.
- Provide management with monthly dashboards highlighting open issues and compliance status.