Comprehensive Quality Assurance Services
GMP, GLP, GDP and GVP Auditing & Inspection
QICS delivers comprehensive auditing and inspection services across the full spectrum of Good Practices (GMP, GLP, GDP, GVP). This includes internal audits, vendor audits, and outsourced activity assessments, ensuring compliance with global regulatory frameworks. Alignment with global regulatory frameworks including SAHPRA, WHO, EU GMP, PIC/S, and FDA.
Audit Experience & Reach
- Over 130 audits conducted internationally, demonstrating extensive hands-on expertise.
- Audits performed across diverse operational environments:
- Sterile manufacturing facilities (aseptic processes, cleanroom operations).
- Non-sterile manufacturing sites (oral solid dosage, liquids, creams).
- Active Pharmaceutical Ingredients (APIs) production plants.
- Excipients and raw material suppliers.
- Packaging facilities (primary and secondary packaging).
- Quality control and analytical laboratories.
- Distribution networks and logistics providers.
Audit Methodology
- Risk-based approach tailored to organizational processes and regulatory requirements.
- Clause-by-clause assessments against applicable GxP and ISO standards.
- Detailed audit trail documentation ensuring transparency and traceability.
- Structured interviews and facility walkthroughs to validate compliance practices.
- Documentation & Reporting.
- Meticulous documentation of audit findings, observations, and non-conformances.
- Development of audit-ready reports with clear categorization of critical, major, and minor findings.
- Regulatory referencing to support corrective actions and demonstrate compliance alignment.
- Corrective & Preventive Action (CAPA) Management
- Translation of findings into actionable recommendations.
- Support in root cause analysis and development of effective CAPA plans.
- Follow-up audits to verify CAPA implementation and effectiveness.
- Continuous improvement focuses to strengthen compliance culture and operational resilience.
ISO Standards Integration​
ISO 45001 and ISO 45003
- Risk-based compliance planning: QICS develops tailored OH&S strategies based on operational risk profiles, ensuring proactive hazard identification and mitigation.
- Incident reporting and emergency preparedness: We implement robust systems for capturing, investigating, and responding to workplace incidents, including emergency drills and escalation protocols.
- Worker participation frameworks: Our approach promotes active employee involvement in safety committees, risk assessments, and continuous improvement initiatives.
- Legal and regulatory alignment: QICS ensures full compliance with South African OH&S legislation and international standards, including WHO, and PIC/S expectations.
- Integrated systems approach: We align ISO 45001 with ISO 9001 (Quality), ISO 45003, ISO 14001 (Environmental) to create unified management systems that support safety, quality, and sustainability across operations.
| Standard | Focus Area | Integration Capability |
|---|---|---|
| ISO 45001 | Occupational Health & Safety: Workplace safety and risk management. |
|
| ISO 45003 | Psychological Health & Safety in the Workplace: Employee mental health, well-being, and psychosocial risk management. |
Documentation Development & Control
- Standard Operating Procedures (SOPs)
We develop and refine SOPs to ensure they are clear, consistent, and aligned with applicable regulatory standards (e.g., GMP, ISO 9001, ISO 13485). Each SOP is tailored to reflect actual operational practices while supporting audit readiness and employee training.
- Batch Record Review:
QICS conducts detailed reviews of manufacturing and laboratory batch records to verify accuracy, completeness, and traceability. We assess documentation for compliance with data integrity principles and ensure alignment with product specifications and regulatory expectations.
- Audit Trail & Regulatory Referencing:
We support clients in establishing robust audit trails and cross-referencing documentation with applicable regulatory clauses. This ensures transparency, accountability, and ease of navigation during inspections and audits.
Independent Quality Compliance Investigations
QICS offers impartial, expert-led investigations into quality incidents, regulatory breaches, and operational failures. These services are ideal for:
- Root cause analysis of recurring deviations or inspection findings.
- Third-party assessments of vendor or outsourced activity compliance.
- Remediation planning and documentation to support regulatory closure.
Deviation & CAPA Management
- Deviation Handling:
QICS assists in managing deviations through structured documentation, root cause analysis, and risk evaluation. We help define clear categorization (critical, major, minor), assess impact, and propose containment actions.
- Corrective and Preventive Action (CAPA):
Our CAPA services include:
- Independent investigation of quality issues, non-conformances, and audit findings.
- Development of CAPA plans with defined timelines, responsibilities, and measurable outcomes.
- Effectiveness checks to verify that corrective actions have resolved the root cause and preventive actions are sustainable.
- Integration of CAPA tracking into QMS dashboards and audit schedules.
Training & Capacity Building
At Quality Integrity Check Solution (QICS), we design and deliver tailored training programs that empower organizations to build competence, strengthen compliance culture, and achieve sustainable regulatory alignment. Our training is interactive, practical, and delivered by an ETDP SETA-accredited Train-the-Trainer facilitator, ensuring that participants gain both theoretical knowledge and hands-on skills applicable to their daily operations.
Core Training Areas
Good Manufacturing Practice (GMP):
- Principles of GMP and their application in manufacturing and laboratory environments.
- Documentation practices, hygiene, contamination control, and validation essentials.
- Case studies on inspection findings and how to address them effectively.
Good Documentation Practice (GDP):
- Ensuring accuracy, completeness, and traceability in records.
- Data integrity principles and audit trail management.
- Practical exercises on SOP writing, batch record review, and deviation documentation.
Risk Assessment & Root Cause Analysis:
- Structured methodologies for identifying, evaluating, and mitigating risks.
- Tools such as FMEA (Failure Mode and Effects Analysis) and fishbone diagrams.
- Root cause analysis techniques to support effective CAPA management.
- Corrective and Preventive Action (CAPA) Management:
- Investigation of deviations and non-conformances.
- CAPA documentation, implementation, and effectiveness verification.
- Integration of CAPA into continuous improvement frameworks.
Occupational Health & Safety (ISO 45001 & ISO 45003):
- Workplace hazard identification and risk-based compliance planning.
- Incident reporting, emergency preparedness, and worker participation frameworks.
- Psychological health and safety: managing stress, workload, and psychosocial risks.
- Leadership accountability and embedding OH&S culture across the organization.
Training Delivery Approach
- Interactive Learning: Role plays, group discussions, and scenario-based exercises.
- Structured Materials: Comprehensive manuals, SOP templates, and regulatory reference guides.
- Case Studies: Real-world examples from audits and inspections across Africa, Asia, and Europe.
- Post-Training Evaluations: Assessments to measure knowledge transfer and training effectiveness.
- Customization: Programs tailored to client-specific processes, regulatory requirements, and industry sector.
Change Management
QICS supports organizations in navigating regulatory, operational, and cultural transitions with structured change management frameworks that ensure compliance, minimize disruption, and embed sustainable improvements. Our approach integrates technical precision with people-focused strategies to strengthen resilience and adaptability across all levels of the organization.
Scope of Services
Regulatory Change Implementation
- Guidance on adopting new or revised GMP, GLP, GDP and GVP , ISO 45001 with ISO 9001, ISO 45003, ISO 14001 standards.
- Gap analysis to identify compliance risks and prioritize corrective actions.
- Development of transition roadmaps aligned with regulatory timelines and business objectives.
Organizational Change Enablement
- Stakeholder engagement strategies to build awareness, ownership, and accountability.
- Communication plans tailored to leadership, operational teams, and external partners.
- Structured workshops to prepare employees for new processes, systems, or cultural shifts.
Process & System Integration
- Harmonization of documentation, SOPs, and QMS frameworks to reflect updated requirements.
- Risk-based evaluation of process changes to ensure continuity and compliance.
- Validation and verification support for new systems or modified workflows.
Training & Competency Development
- Targeted training programs to equip staff with skills for managing and sustaining change.
- Leadership coaching to strengthen change champions and embed accountability.
- Post-change evaluations to measure effectiveness and identify opportunities for continuous improvement.
Sustainability & Continuous Improvement
- Monitoring and reporting mechanisms to track change adoption and compliance outcomes.
- Integration of change management into CAPA and audit schedules for long-term resilience.
- Embedding a culture of adaptability, ensuring organizations remain agile in dynamic regulatory environments.