NTP Radioisotopes SOC Ltd seeks quotations for a GMP consultant to enhance its self-inspection system, ensuring compliance with regulatory standards. The consultant will assess current practices and provide recommendations for improvement.
NTP Radioisotopes SOC Ltd is inviting qualified consultants to submit quotations for Good Manufacturing Practices (GMP) consulting services. The primary objective is to strengthen the company's self-inspection system through an external audit and assessment. The selected consultant will evaluate existing Standard Operating Procedures (SOPs), review past audit reports, and identify compliance gaps against PIC/S GMP, ICH Q7, and SAHPRA requirements. The consultant will also design a risk-based self-inspection program, conduct a mock GMP inspection, and provide training to internal auditors.
The scope of work includes a comprehensive review of current systems, enhancement of the self-inspection program, execution of a full mock inspection, gap analysis, and support for Corrective and Preventive Actions (CAPA). The consultant must have a minimum of 10 years of experience in GMP quality or regulatory roles, along with strong knowledge of data integrity and quality risk management. This engagement will not only ensure compliance with international standards but also support the sustainable implementation of effective internal audit practices, ultimately enhancing the quality and reliability of NTP's products and services.
This tender is suitable for consulting firms specializing in GMP compliance, quality assurance, and regulatory affairs, particularly those with experience in the pharmaceutical or nuclear medicine sectors.