Objectives

The primary objective of this tender is to appoint an expert GMP Advisor/Principal Engineering Consultant to evaluate the current infrastructure of the vaccine facility, identify necessary modifications, estimate costs, and develop a comprehensive execution roadmap to achieve Good Manufacturing Practice (GMP) certification in accordance with DALRRD guidelines. The goal is to bring the facility to compliance, ensuring it meets international GMP standards for vaccine manufacturing.

Scope

The scope encompasses:

• Evaluation and adjudication of management, administration, and monitoring of the GMP project processes.
• Facility assessment and gap analysis focusing on quality management systems, material and personnel flows, and production equipment to identify deviations from cGMP requirements.
• 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, aligning with cGMP and regulatory standards.
• Qualification and validation strategies covering IQ/OQ/PQ and compliance with international regulatory requirements.
• Review of existing equipment and infrastructure, ensuring adherence to latest GMP specifications, including ongoing and future procurement.
• Ongoing project advisory and oversight during construction, monitoring performance of contractors and ensuring quality assurance.
• Knowledge transfer and establishment of maintenance and quality assurance schedules post-project completion.

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 prevent contamination and ensure proper air classification (Grades A-D).
• Development of validation strategies for IQ/OQ/PQ in line with international standards.
• Review and validation of equipment, control systems, automation, and utilities to meet GMP compliance.
• Provision of oversight during construction, commissioning, and validation phases.
• Preparation of documentation, procedures, and protocols aligned with GMP and regulatory requirements.
• Evaluation of existing infrastructure and equipment, including those already completed, in design, or to be procured, ensuring compliance with latest GMP standards.

Skills Requirements

The tender mandates the inclusion of a multidisciplinary team with the following expertise:

• GMP Auditor and Quality Assurance specialists with proven experience in vaccine or pharmaceutical manufacturing.
• Mechanical, Structural/Civil, Electrical, and Instrumentation Engineers with GMP project experience.
• Process Engineers and Quantity Surveyors familiar with GMP facility design and cost estimation.
• Cleanroom and Molecular Environmental specialists.
• Fire Safety and HVAC experts with relevant GMP experience.
• Zoning Specialists and Regulatory Compliance experts.
• All 16 listed specialists (as per pages 20-21 of the tender document) must be part of the project team, with valid professional registrations and a minimum of 5-10 years relevant GMP experience.
• Team members must provide detailed CVs, valid certifications, and references demonstrating successful GMP project execution and regulatory audits.

Additionally, the team should demonstrate capability in project management, risk mitigation, and knowledge transfer to ensure sustainable GMP compliance.