Objectives

The primary objective of this tender is to appoint an expert GMP Advisor or Principal Engineering Consultant to evaluate the current infrastructure of the vaccine facility, identify necessary modifications, estimate costs, and develop an execution roadmap to achieve Good Manufacturing Practice (GMP) certification in line with Department of Agriculture, Land Reform and Rural Development (DALRRD) standards. The goal is to bring the facility to final completion on brief, within budget, and on time, ensuring compliance with GMP guidelines to facilitate certification and international recognition.

Scope

The scope encompasses:

• Evaluation and adjudication of management, administration, and monitoring of the cGMP project processes.
• Facility assessment and gap analysis focusing on quality management systems, material and personnel flows, and production equipment.
• Design and engineering oversight, including process piping, equipment, control systems, and automation to prevent cross-contamination and ensure proper air classification.
• Project execution and commissioning, including validation services and alignment with GMP standards.
• Qualification and validation strategies covering Installation, Operational, and Performance Qualification (IQ/OQ/PQ) in accordance with international regulatory requirements.
• Ongoing project advisory and oversight during construction, monitoring performance of contractors, and ensuring adherence to GMP standards.
• Knowledge transfer and establishing ongoing quality assurance and maintenance schedules.

The project is divided into two phases: initial evaluation and design oversight, followed by project execution, commissioning, validation, and ongoing oversight services.

Technical Requirements

The technical requirements include:

• Comprehensive facility assessment and gap analysis to identify deviations from GMP standards.
• Design of process piping and equipment layouts to ensure contamination control and proper air classification (Grades A-D).
• Development of qualification and validation strategies aligned with international regulatory standards.
• Provision of detailed design, engineering oversight, and validation services for equipment, automation, and process systems.
• Implementation of contamination control measures, quality management systems, and personnel flow protocols.
• Monitoring and evaluation of construction and commissioning activities, including validation and qualification processes.
• Preparation of documentation, procedures, and reports to support GMP certification.

Skills Requirements

The tender mandates the inclusion of a project team comprising 16 specialists listed on pages 20-21, with the following qualifications and experience:

• Valid professional registrations relevant to their roles (e.g., SACAP for Architects, SACNASP for Environmental Specialists, etc.).
• Minimum of 5-10 years of relevant GMP project experience for each specialist.
• Proven track record of successfully passing international or local regulatory audits (e.g., SAHPRA, WHO).
• Detailed CVs, certified copies of qualifications, IDs, and references for all specialists.
• Demonstrated experience in GMP facility design, validation, and commissioning.

The team must include expertise in architecture, GMP auditing, mechanical, structural/civil, electrical, instrumentation, process engineering, quantity surveying, cleanroom design, molecular biology, fire safety, HVAC, utilities, and quality assurance.