Writing a capacity plan
This article provides a template structure and explanation of factors to consider when developing your own capacity plan. More information about what to include can be found in our article on developing an aseptic capacity plan (SPS page).
Introduction
The introduction provides a high-level service profile, making it clear that the plan supports safe and sustainable aseptic operations rather than just product output. This section should be a summary of the details held in the Site Master File or Quality Manual.
Include a service overview, for example, systemic anti-cancer chemotherapy (SACT), intrathecal chemotherapy, radiopharmaceuticals, parenteral nutrition and/or novel therapies.
State the regulatory context in which the unit operates, for example, MS licence or section 10 and describe the facility classification, operational and staffing models.
Describe any unique circumstances, such as interdependencies between aseptic and radiopharmacy units with shared staff, or staff working across sites.
Scope
The scope explains the purpose of the document and what it is trying to achieve. This can help prevent misunderstandings because it gives context and makes it clear who the document applies to. The scope also defines what the document does not cover, so that readers understand the document’s focus and limitations.
Describe the activities, facilities, products and staff groups included in the capacity plan and explicitly state any areas that are excluded.
Purpose
Explain the intention of the capacity plan, for example, workforce forecasting or justification for refurbishment. You could include a statement that the intention of the plan is to maintain quality and prioritise patient safety over output.
Refer to regulatory drivers such as EU Good Manufacturing Practice (GMP), QAAPS and relevant guidance such as IRR and IRMER regulations.
Example text you could use is shown below:
Aseptic preparation involves the manufacture of sterile medicines for vulnerable patients, including SACT, parenteral nutrition and other high-risk injectable therapies. These products must be prepared within tightly controlled environments and in accordance with national regulatory standards (reference relevant standards).
The purpose of this capacity plan is to define the safe operational limits of the aseptic service based on the available facilities, equipment, workforce and quality assurance systems.
This plan ensures that aseptic preparation services can meet current and projected clinical demand without compromising patient safety, product quality or regulatory compliance.
Demand forecasting
Demand forecasting allows you to predict future workload so that resources, equipment, and staffing can be planned proactively without compromising quality or compliance. This includes reviewing both historical and anticipated future demands.
More information about demand forecasting can be found in our article managing aseptic service capacity effectively (SPS page).
Historical demand
Reviewing historical demand allows you to analyse and understand current workload and trends.
Include at least 12 to 24 months of data per product category, broken down into different categories to suit your service.
Forecasted demand
Forecasting demand can be challenging; you should include all information you have available to you. Focus on factors such as predicted growth (for example, clinical guidelines, new therapies, business cases) and planned projects (for example, new equipment installation).
Consider strategic organisational aims, such as increasing participation in clinical trials, using input from clinicians, pharmacy leads, and organisational strategy teams. Clearly document any assumptions you have made where information is not available.
Facility design and classification
This section describes the physical capacity and classification limits of the unit, allowing accurate representation of capabilities and limitations of the facility. This helps to streamline current workflows and identify future opportunities to improve capacity or other developments. Consider whether additional staff could be accommodated in the current facility to match an increased workload.
Describe the facility in detail, including room sizes, grades and workflows. Include maximum occupancy levels based on environmental limits. Consider all aspects of storage from raw materials and consumables to final products.
Include floor plans and flow diagrams in this section and reference recent cleanroom validation reports in this section.
Equipment capability
Describe the capabilities and limitations of the equipment. This helps streamline current workflows, identify future opportunities to expand and other potential service developments.
Include all equipment, for example, auto-compounders, centrifuges and particle counters, in addition to larger items such as refrigerators and isolators.
Include the frequency of planned maintenance and downtime, referencing validation reports and servicing logs, using local knowledge to describe equipment reliability.
Digital infrastructure and technology
Clearly understanding the capabilities and limitations of the digital infrastructure can support effective workload management and future planning.
Document all IT systems needed to maintain production capabilities, with detail as to whether these are GMP-critical and their qualification status. Include details of system ownership and access permissions, including maintenance and contract updates. Upgrade or replacement plans should be included in the capacity plan, as significant resource may be required to manage and validate these.
EU GMP requires that each IT system has a data-integrity risk assessment (DIRA), which you should refer to in your capacity plan. If you are yet to develop DIRAs for your IT systems, you should include time and resource to develop these.
Financial and resource planning
The capacity plan is an essential tool to aid future planning and service development. Including a financial and resource planning section can support future business cases for service expansion or improvements.
Include all known income and expenditure, for example, staffing budgets, starting materials and consumables costs. Include services such as laundry and QC or QA costs.
Production scheduling
Scheduling allows for a comprehensive assessment of current workload distribution and pressures, supporting service review and providing opportunities to identify bottlenecks and maximise efficiencies.
Include details such as opening hours, maximum operating hours allowable within validated conditions. Include details of shift patterns, turnaround times and downtime for essential routine activities such as cleaning.
Workforce
This section details the current capabilities and development needs of the workforce. This allows identification of knowledge or skills gaps, supporting development of plans to ensure service resilience and succession planning.
Competency and requalification
Include a summary of training and the qualification status of staff, to highlight training needs and activities required to maintain a robust workforce. This ensures the necessary skill mix is available to meet patient demand without compromising product quality or safety.
Provide brief details of your training plan, revalidation schedules and any known challenges in maintaining a competent workforce, such as retention difficulties.
Task allocation
Map defined tasks to each role (for example, aseptic preparation, cleaning, checking), detailing known factors that restrict capacity. Describe how workload is matched to competence and role, highlighting knowledge and skills gaps. Describe any strategies put in place to address gaps and improve service resilience, for example, cross-training and succession planning.
Rotas and resilience
This section highlights how the available workforce is matched to the current production demand, allowing you to identify constraints and inefficiencies.
Describe known peaks in activity and how staffing levels match this. Detail any regular overtime and/or locum time which is required to meet the current workload.
Quality related activities
Maintaining the quality assurance processes is key to smooth running operational activities. As operations cannot run without these processes, adequate resourcing is essential.
The article on incorporating quality related activities into your capacity plan (SPS page) provides more detail on what to include in this section of your capacity plan.
Capacity tracking
Explain how real-time capacity visibility is provided and utilised to ensure accurate data is readily available and used. This supports production decisions ensuring an adaptable and resilient service, including early escalation of potential issues.
Include a description of the capacity monitoring tool in use, including any local factors which have been incorporated. Describe how local timings have been calculated. State the process and responsibilities for data submission, review and escalation, including interaction with other elements of the Pharmaceutical Quality System (PQS), such as deviation and change management. Results should be trended and presented in Quality Management Meetings.
Capacity risks and contingency
Use this section of your plan to proactively highlight the capacity limits of the service and any mitigations that can be implemented.
Include staffing, supply chain, equipment and facility risks.
Document impact assessments and current mitigations, for example, cross-training, extending working hours, availability of back-up equipment. If there is no mitigation, this should be stated and the risk highlighted.
The facility, equipment and digital systems should all be recorded on the organisation’s capital plan or asset register.
It may be appropriate to document a detailed risk assessment outside of the capacity plan, for example the risk register or Business Continuity Plan.