Objectives

The primary objective of this tender is to design and deliver a comprehensive sterile manufacturing training program. The training aims to equip participants with the necessary knowledge and skills to ensure sterility assurance, effective problem solving and troubleshooting, understanding of cleanroom environments, environmental monitoring principles, and compliance with GMP and ISO standards. Participants should also be able to differentiate between aseptic processing and terminal sterilization, respond effectively to deviations and non-conformances, and implement CAPA related to sterile operations.

Scope

The scope involves providing training for six participants on sterile manufacturing processes, including:

• Designing and delivering a comprehensive training program aligned with industry best practices.
• Covering product types such as sterile injectables and biologics.
• Including assessments, summary reports, and illustrations of best industry practices.
• Addressing GMP Annex 1, FDA 21 CFR Part 210/211, ISO 9001 standards.
• Training participants to understand and operate within bio-pharmaceutical manufacturing environments, including cleanrooms, RABS, isolators, and Grade A/B/C/D areas.

Technical Requirements

The training must adhere to the following technical standards and requirements:

• Compliance with GMP Annex 1, FDA 21 CFR Part 210/211, and ISO 9001 standards.
• Inclusion of illustrations of best industry practices and assessments.
• Provision of a minimum of 6 training sessions for 6 participants.
• Training content must enable participants to:
• Understand sterilization processes and environmental monitoring.
• Differentiate aseptic processing from terminal sterilization.
• Respond to deviations and implement CAPA procedures.
• Gain awareness of recent GMP and ISO updates.

Skills Requirements

The selected supplier must demonstrate the following skills and qualifications:

• Proven experience in designing and delivering sterile manufacturing training programs.
• Accredited training expertise aligned with industry standards.
• Facilitator CVs demonstrating relevant expertise and industry experience.
• Ability to assess and illustrate best practices in sterile manufacturing.
• Knowledge of GMP, FDA, and ISO standards related to bio-pharmaceutical manufacturing.
• Effective communication skills to convey complex technical concepts clearly.