Objectives

The primary objective of this RFQ is to appoint a qualified external GMP (Good Manufacturing Practices) consultant to assess and enhance NTP Radioisotopes SOC Ltd's self-inspection (internal audit) system. The consultant will conduct an independent GMP self-inspection, identify gaps against applicable standards (PIC/S GMP, ICH Q7, SAHPRA, and international regulators), and support the implementation of a risk-based internal audit program to ensure compliance and continuous improvement.

Scope

The scope of work includes:

• Evaluation of current self-inspection SOPs, procedures, and plans.
• Review of previous internal audit reports, SAHPRA audit observations, CAPAs, and effectiveness checks.
• Assessment of alignment with PIC/S GMP, Quality Risk Management, and industry best practices.
• Design or improvement of a risk-based self-inspection program, including audit schedules, independence criteria, and risk-based audit frequency.
• Provision of audit checklists, report templates, and tracking tools.
• Execution of a full mock GMP site inspection across various departments such as Quality Management, Production, Quality Control, Dispatch, Maintenance, Validation, and Documentation.
• Preparation of a GMP gap analysis report referencing relevant standards.
• Facilitation of CAPA development workshops, root cause analysis, and review of proposed CAPAs.
• Training internal auditors and relevant staff on GMP audit techniques, self-inspection, and data integrity risks.
• Optional follow-up assessment to verify CAPA implementation and effectiveness.

Technical Requirements

The selected consultant must demonstrate:

• Proven experience with SAHPRA inspections and PIC/S GMP (Part I and/or II).
• At least 10 years of experience in GMP quality/regulatory roles and conducting regulatory inspections.
• Strong knowledge of Data Integrity and Quality Risk Management principles.
• Relevant professional qualifications (e.g., pharmacist, quality professional, GMP auditor).

The consultant must support an acceptable technical solution, including:

• Evaluation of current GMP compliance status.
• Design of risk-based self-inspection programs.
• Execution of mock GMP inspections.
• Preparation of comprehensive gap analysis reports.
• Provision of training and CAPA facilitation.

Skills Requirements

• Extensive experience in GMP audits and inspections, particularly with SAHPRA and PIC/S standards.
• Strong understanding of pharmaceutical quality systems and data integrity.
• Ability to develop and implement risk-based inspection programs.
• Excellent analytical and root cause analysis skills (e.g., 5 Why, Fishbone).
• Effective communication skills for training and workshop facilitation.
• Proven track record in supporting regulatory compliance and continuous improvement initiatives.