Decommissioning is a general term for a process to remove something from active status. It may be a precursor to putting facilities/equipment into storage, repurposing, or demolition/disposal. There are many factors and requirements to consider in this process, including documentation, process management, Environmental, Health, and Safety (EHS), compliance, financial, operational, maintenance, supporting contracts, and interfaces with other facilities and site utilities. It is recommended that a decommissioning project plan is developed at an early stage with all the stakeholders to ensure that all factors have been given due consideration, and the scope of work, and related roles and responsibilities are clearly defined. It is also recommended that a formal decommissioning checklist is used to track progress and ensure that all necessary activities are completed. Depending on the scope and scale of the project, the documentation could range from a simple checklist (in the case of a single system) or a detailed overall decommissioning plan that includes many systems or areas (such as decommissioning of an entire facility). Using the content from The ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities, this online course provides checklists, templates, flowcharts and example documents, that are currently in use for decommissioning of pharmaceutical equipment and facilities in the USA and Europe. Methods and systems that would satisfy the requirements of Regulatory Authorities based on practices that have been developed in the US and Europe will also be highlighted.
Course Modules/Learning Objectives
- Module 1: Introduction Responsibilities, Requirements and Planning
Understand the decommissioning process and approach for the areas and systems to be decommissioned. Understand regulatory requirements (local authority, Environmental Health and Safety (EHS), U.S. Food and Drug Administration (FDA), Medicines and Healthcare Products Regulatory Agency (MHRA)). Review the requirements for developing a closure plan.
- Module 2: GxP and GEP
Understand health and safety procedures for each stage of the decommissioning process. Understand the purpose of the GXP decommissioning process: continuity of supply, compliance with regulations and codes of practice, compliant with Environmental, Health, & Safety (EHS), and understand asset disposal. Understand the GEP decommissioning process.
- Module 3: Disposal, Remediation and Demolition
Understand the process for the disposal of assets at the decommissioning site. Describe the remediation and demolition phases of a decommissioning project. Immediately apply the course learning objectives with a complimentary download of the ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities Take Back to Your Job Requirements for the decommissioning of equipment and facilities including development of a clear objective, strategic action plan, and defined roles and responsibilities. Methods and systems that satisfy the requirements of Regulatory Authorities in US and Europe including considerations of both regulatory and business needs Definition and application of a structured process Ability to utilize templates, flowcharts, and examples of how this approach can be carried out in practice. Ability to accurately analyze data across a supply chain to show historical data for products made in a closed facility and the effective date of closure. A process to define the decommissioning activities based on risk. Developing decommissioning determination statements. Ability to identify all of the items, systems, and processes to be decommissioned that should be assessed and categorized as either Good Engineering Practice (GEP) or Good “x” Practice (GxP) and the activities that may be common to both GEP and GxP.
Personnel responsible for decommissioning facilities Staff and other operational facility management Project manager, EHS representative, or Engineer Course.
Dan Franklin, CIRM, CxA is the Regional Manager of Integrated Project Services’ Midwest US Commissioning and Qualification operations based in Indianapolis, Indiana. Current responsibilities include consulting; and program planning, delivery and execution support for capital projects and risk-based verification programs. Mr. Franklin has over 30 years of project delivery and operations support experience. Graduated from Lewis University with a Bachelor of Science degree in Aviation Maintenance Management, Mr. Franklin has also earned an MBA degree from National University and a number of industry certifications & licenses. Mr. Franklin supports the ISPE Commissioning & Qualification COP as a Steering Committee Member, and has served as a contributing author to the ISPE FE Guide, the C&Q Applied Risk Management Good Practice Guide, and the ISPE Decommissioning Good Practice Guide. He is also a designated classroom training Instructor for the new ISPE course and workshop; “Risk- Based Verification of Facilities, Systems and Equipment” and for the Baseline Guide 5 course, “Commissioning and Qualification.”