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Level: Intermediate
TCM Section(s):
7.2. Schedule Planning and Development
10.3. Change Management
Venue: 2021 AACE International Conference & Expo
Abstract: Initiating a pharmaceutical capital project requires a deep understanding of the unique processes related to current Good Manufacturing Practices (cGMP), along with experience in the design, procurement, construction, commissioning, qualification and validation of facilities, utilities and equipment. Additionally, planning should account for the regulatory affairs that will allow bringing a product to market in this highly regulated industry.While most of the pharmaceutical capital projects are schedule-driven given the business model of being first-to-market, improper planning and delays constantly jeopardize the release of new products.
This paper describes practical techniques to plan and schedule new construction and renovations of existing buildings, typical sequences and durations used for commissioning, qualification and validation activities, timing for engagement with different stakeholders, common pharmaceutical terminology employed during all phases of the project, and recommended approaches to leverage previously performed work to potentially gain time in the project schedule. The author has successfully used these practices in manufacturing facilities for oral, parenteral and topical administration products located in the Americas, Europe and Asia.
Level: Intermediate
TCM Section(s):
7.2. Schedule Planning and Development
10.3. Change Management
Venue: 2021 AACE International Conference & Expo
Abstract: Initiating a pharmaceutical capital project requires a deep understanding of the unique processes related to current Good Manufacturing Practices (cGMP), along with experience in the design, procurement, construction, commissioning, qualification and validation of facilities, utilities and equipment. Additionally, planning should account for the regulatory affairs that will allow bringing a product to market in this highly regulated industry.While most of the pharmaceutical capital projects are schedule-driven given the business model of being first-to-market, improper planning and delays constantly jeopardize the release of new products.
This paper describes practical techniques to plan and schedule new construction and renovations of existing buildings, typical sequences and durations used for commissioning, qualification and validation activities, timing for engagement with different stakeholders, common pharmaceutical terminology employed during all phases of the project, and recommended approaches to leverage previously performed work to potentially gain time in the project schedule. The author has successfully used these practices in manufacturing facilities for oral, parenteral and topical administration products located in the Americas, Europe and Asia.