This tender seeks a professional engineering firm to modify an existing structure for a Radioiodine Active Pharmaceutical Ingredient (API) facility. Key requirements include design, management, and compliance with cGMP standards.
The South African Nuclear Energy Corporation is inviting bids for the appointment of a professional engineering services firm to oversee the modification of an existing structure to establish a Radioiodine Active Pharmaceutical Ingredient (API) facility. The successful bidder will be responsible for comprehensive design and management services, ensuring that all modifications comply with current Good Manufacturing Practices (cGMP) and relevant safety regulations. The project will take place at the NECSA complex and aims to enhance the production capabilities for non-sterile I-131 API in liquid form.
The scope of work includes conducting site assessments, developing detailed engineering designs, and managing the construction process. The firm must demonstrate expertise in pharmaceutical facility design, HVAC systems, and regulatory compliance. Additionally, the project will require close collaboration with various stakeholders to ensure timely delivery and adherence to quality standards. This initiative not only aims to improve production efficiency but also to ensure the safety and integrity of the manufacturing process, ultimately contributing to the healthcare sector's needs for radioisotopes.
This tender is suitable for engineering firms with experience in pharmaceutical facility design and construction, particularly those familiar with cGMP standards and the production of active pharmaceutical ingredients.
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