GMP Process Mapping and Efficiency Optimization in Aseptic Manufacturing

📘 Project Title: GMP Process Mapping and Efficiency Optimisation in Aseptic Manufacturing 🏭 Sector: Pharmaceutical Manufacturing – Aseptic Fill/Finish & Sterile Production 📄 Project Description: This project focuses on improving the efficiency, compliance, and traceability of workflows within a GMP Grade A/B cleanroom environment. Using Lean Six Sigma and GMP-compliant methodologies, the objective is to map critical manufacturing processes—including material flow, personnel movement, and batch execution—in aseptic areas. By identifying non-value-adding steps, delays, and contamination risks, the project proposes a streamlined layout and revised SOPs that maintain regulatory compliance while enhancing productivity. Key deliverables include a detailed process flow map, a risk assessment (FMEA) of contamination points, time-and-motion analysis of operator interventions, and a set of optimisation proposals. Recommendations will also be aligned with current EU GMP Annex 1 expectations, particularly around unidirectional flow, intervention minimisation, and aseptic behaviours. This project can support improved batch throughput, reduced deviation rates, and readiness for regulatory audits or HPRA/EMA inspections. ✅ Learning Objectives / Outcomes: Participants or team members involved in this project will be able to: Apply GMP and Annex 1 guidelines to aseptic manufacturing process flows. Use SIPOC, VSM (Value Stream Mapping), and spaghetti diagrams to visualise workflows. Identify contamination risks and inefficiencies in cleanroom practices. Recommend improvements without compromising sterility assurance levels (SAL). Collaborate across QA, Production, and Engineering to implement GMP-compliant changes. 🧠 Ideal for: Quality Engineers Aseptic Manufacturing Operators Process Engineers Validation/Compliance Specialists Continuous Improvement Teams