Analytical Excellence: Consulting for QC Labs and Analytical Development
Optimizing Methods, Ensuring Compliance, and Enhancing Efficiency Across the Analytical Lifecycle.
Introduction: Robust analytical data is the bedrock of quality and compliance in regulated industries like Pharmaceuticals, Biotechnology, Medical Devices, and increasingly, high-end Supplements and Cosmetics.
Whether performed in-house by Quality Control (QC) laboratories or outsourced to Contract Testing Laboratories (CTLs), analytical activities, from initial Analytical Development and method validation to routine testing and stability programs, must be accurate, efficient, and compliant. Regulatory expectations for method lifecycle management and data integrity are high.
Marzouk Consulting Group provides specialized expertise to support laboratories and analytical development groups in optimizing performance, ensuring compliance (ISO 17025, GMP/GLP), developing robust methods, and managing the entire analytical lifecycle effectively.
Key Challenges We Address:
Analytical Development:
Developing robust, phase-appropriate analytical methods (assays, impurities, dissolution, microbial tests, etc.).
Designing and executing comprehensive method validation studies compliant with ICH, USP, and other relevant guidelines.
Managing complex analytical method transfer processes between labs or sites.
Designing and managing compliant and efficient stability testing programs.
Setting and justifying appropriate specifications for materials and products.
Troubleshooting difficult analytical methods and OOS/OOT (Out-of-Specification/Out-of-Trend) investigations.
Implementing Analytical Quality by Design (AQbD) principles.
QC & Contract Lab Operations:
Implementing and maintaining compliant Quality Management Systems (ISO/IEC 17025, GMP/GLP where applicable).
Ensuring robust data integrity practices and systems (ALCOA+).
Optimizing laboratory workflows to improve efficiency and reduce Turnaround Time (TAT).
Effective sample management, tracking, and LIMS utilization.
Managing equipment qualification, calibration, and maintenance programs.
Training and competency management for analytical staff.
Preparing for and responding effectively to client audits and regulatory inspections.
Our Approach to Analytical Excellence:
We bring a unique blend of deep scientific understanding (chemistry and microbiology), operational expertise (Lean Lab principles), and quality systems knowledge to your analytical challenges. Our approach focuses on:
Supporting the entire analytical lifecycle, from early development through routine use to retirement.
Implementing science-based and risk-based strategies for method development, validation, and transfer.
Driving efficiency and reducing waste in lab operations without compromising quality or compliance.
Ensuring robust data integrity through systems, procedures, and training.
Tailoring solutions to the specific context, whether it's an internal QC lab, a contract testing facility, or an R&D analytical group.
Explore Our Services for Analytical Operations & Development:
Method Development & Validation Strategy: (Guidance on phase-appropriate strategies, protocol development/review, ICH/USP compliance).
Analytical Method Transfer Support: (Planning, protocol development, execution oversight, troubleshooting).
Stability Program Design & Management Consulting: (Protocol design, data trending, regulatory compliance).
Specification Setting & Justification Support: (Statistical analysis, regulatory acceptance strategies).
Analytical Laboratory Investigations (OOS/OOT) Consulting: (Root cause analysis, CAPA effectiveness for analytical issues).
Quality Management Systems (ISO 17025, GMP/GLP elements): (Implementation, gap assessments, audit preparation, QMS optimization).
Laboratory Process Optimization (Lean Lab): (Workflow mapping, TAT reduction, 5S, efficiency improvements).
Data Integrity Assessment & Remediation: (System audits, procedure development, training programs).
Equipment Qualification & Validation Support: (Strategy development, documentation review).
LIMS & Laboratory Technology Strategy: (Needs assessment, selection support, implementation guidance).
Leadership Development: (For Laboratory Managers, Analytical Development Leads, QA/QC Supervisors).
Optimize Your Analytical Operations & Development Programs.