A pharmaceutical facility project can lose time before design begins if the project basis is incomplete. Early drawings may look convincing, but they cannot resolve cleanroom zoning, equipment access, utility loads or qualification responsibilities without controlled inputs. The purpose of a first technical review is not to freeze every detail. It is to identify what is known, expose important gaps and establish a basis that different disciplines can use consistently.

The following checklist is designed for owners preparing a greenfield facility, expansion or upgrade. Send the best available information and label assumptions clearly. A preliminary equipment list, marked-up layout and short process narrative are more useful than polished material that hides uncertainty. The review should result in questions, decisions and next engineering steps—not unsupported promises about cost, schedule or regulatory acceptance.

1. Product and Dosage Form

State each product family and dosage form planned for the facility. Indicate whether operations involve sterile products, potent compounds, sensitizers, biological materials, live organisms, solvents or other special hazards. Include the main process steps from receipt of raw materials through manufacturing, packaging and dispatch. Product knowledge drives segregation, containment, cleaning, environmental control and the selection of open or closed processing methods.

Where the portfolio is not final, group products by process and risk rather than listing uncertain brand names. Explain whether campaigns will share rooms or equipment, whether product changeover is expected and what cleaning approach is planned. Identify any cold-chain, light-sensitive or controlled-substance needs. These points establish the questions that must be resolved through quality risk assessment and the user requirement specification.

2. Production Capacity

Provide target annual output and the operating assumptions behind it: batch size, batches per day, shifts, operating days, yield basis and planned growth. For packaging, include line speeds, pack formats and changeover expectations. A single annual number is not enough because the facility must handle peaks, hold times, cleaning periods, maintenance and the sequence between upstream and downstream operations.

Separate the business target from confirmed equipment capability. If capacity is still being studied, give a base case and expansion case. Note whether future equipment, spare room, duplicated utilities or phased construction should be considered. A transparent capacity model helps establish equipment quantities, room sizes, storage volumes, staffing, utility demand and the points at which bottlenecks may occur.

3. Target Market and Regulatory Basis

Identify the markets in which products are expected to be supplied and the regulatory or technical framework the owner intends to apply. Examples may include EU GMP and Annex 1, WHO GMP, applicable FDA cGMP requirements and ISO 14644 for cleanroom classification. These references are not interchangeable certifications, and listing them does not mean that a facility will automatically receive approval.

The project team should translate the target-market basis into specific requirements through the URS, quality risk management and agreed design criteria. Confirm the owner’s quality organization, validation approach and any local authority requirements that also apply. Record areas of uncertainty, because a late change in market basis can affect room grades, airlocks, monitoring, documentation and qualification scope.

4. Site and Existing Building Information

For a new site, send the plot plan, survey, geotechnical information if available, utility connection points, access constraints and local climate data. For an existing building, provide accurate architectural and structural drawings, floor-to-floor heights, column grids, loading limits, roof capacity, fire compartments, egress routes and the location and condition of existing services.

Photographs and a measured survey help reveal constraints that drawings miss. Note whether production must continue during an upgrade, where temporary segregation may be needed and which shutdown windows are possible. State local permitting roles and any landlord or industrial-zone requirements. Site facts determine what can be built, how equipment can enter and how construction will be sequenced without creating unacceptable operational risk.

5. Process Flow

Prepare a simple process flow diagram for each product family. Show material receipt, sampling, dispensing, processing, intermediate holding, transfer, cleaning, packaging, quarantine and release. Identify where materials are open to the environment, where closed transfer is used and where status changes occur. Include waste and rejected material paths, not only the preferred production route.

Add batch sizes, expected hold times and key equipment at each step where known. The diagram does not need to be a formal piping and instrumentation diagram at the first review. Its role is to connect product movement with rooms, people, utilities and controls. Unclear transfers are common sources of layout rework, cross-contamination risk and late requests for pass-throughs or additional airlocks.

6. Personnel and Material Flow

Describe how operators, maintenance staff, visitors, raw materials, components, equipment parts, finished goods, waste and cleaning items enter, move through and leave the controlled areas. Mark flows on the current layout if one exists. State gowning levels and change sequences as presently understood, and identify any requirement to separate incoming and outgoing routes.

Flows should support the operating procedure, not exist only as colored arrows on a plan. Consider shift changes, peak material movements, pallet breakdown, sampling, rejected goods, emergency egress and maintenance access. Where routes cross, define the control method and timing. The objective is a practical operating concept that supports contamination control while avoiding unnecessary rooms, doors and handling steps.

7. Cleanroom Classification

List proposed room classifications or grades, including the operating state and any local terminology. Where classifications are not decided, describe the process exposure and product risk so that the team can develop a justified concept. Include pressure relationships, airlock functions, recovery expectations and critical background conditions around barrier or containment equipment.

Classification is only one part of environmental control. Surface finishes, cleaning, personnel practices, material transfer, monitoring and HVAC performance work together. Avoid assigning higher classifications simply as a precaution; that can increase energy, qualification and operational burden without addressing the actual risk. Applicable classes and test methods should be agreed in the project URS and design criteria.

8. HVAC and Environmental Conditions

Provide temperature and relative-humidity ranges, occupancy, equipment heat loads, exhaust needs, room pressure targets and any recovery or airborne-contamination requirements. Identify processes that generate heat, moisture, dust, vapor or odor. State the outside design conditions and available space for air-handling equipment, ducts, filters and maintenance access.

If production conditions differ from comfort conditions, explain why and when they apply. Note required redundancy, operating schedules, setback modes and power-loss response. Air-change rates should not be selected in isolation; they follow the contamination-control need, heat and particle loads, room volume and airflow pattern. Early HVAC information is essential for plant-space planning and realistic utility estimates.

9. Process Utilities

List every utility needed by the process and equipment: electrical loads, clean and plant compressed air, purified water, water for injection where applicable, steam, clean steam, gases, chilled water, cooling water, vacuum, extraction, drainage and data connections. Give pressure, flow, temperature and quality requirements where supplier data is available.

Distinguish point-of-use demand from average demand and identify simultaneous operation assumptions. Explain whether utilities already exist, require expansion or must be created as new systems. Include sampling, sanitization, drainage, return loops and future capacity. The first review should also identify who is responsible for generation, distribution, equipment connections, controls, commissioning and qualification for each utility boundary.

10. Equipment List

Send an equipment schedule with equipment name, quantity, supplier if approved for disclosure, model or preliminary size, capacity, utilities, exhaust, weight, heat release, control interface and status. Mark whether each item is existing, owner-supplied, to be procured or still under study. Attach available general-arrangement drawings and technical data sheets.

Include mobile items, laboratory equipment, washing units, lifting devices, storage systems and maintenance tools that influence space. Confirm the largest transport dimensions and required dismantling route. Equipment is a major source of cross-discipline data: layout, structure, utilities, HVAC, automation, safety, cleaning and qualification all depend on it. Missing or changing data should be placed in an interface register with an owner and due date.

11. Local Contractor and Installation Model

Explain the intended delivery model. Will GENO provide coordinated engineering and systems while local contractors execute civil, MEP or installation work? Are local permits, stamped design or licensed supervision required? Identify contractors already appointed, site labor rules, import constraints, tax boundaries, temporary facilities and the languages used for site communication.

Responsibilities should be expressed as interfaces, not broad labels. For each package, define who designs, supplies, transports, unloads, stores, installs, connects, inspects, tests and hands over the work. Local execution can be integrated effectively when information, quality plans and decision authority are aligned early. Unclear boundaries create gaps, duplicated costs and disputes during commissioning.

12. Schedule and Budget Basis

Provide the required production start date and the business milestones behind it. Separate concept, design, approvals, long-lead procurement, construction, utility availability, commissioning, qualification and operational readiness. Identify fixed dates, flexible dates and external dependencies such as financing, land access, authority review or equipment delivery.

For budget, state the cost categories included, currency, pricing date, taxes, freight, local work, contingencies and owner-supplied packages. If no approved budget exists, say so and define the decision the first estimate must support. Early figures should be ranges with assumptions, not false precision. Scope maturity and risk should be visible so schedule and budget can be updated as decisions are made.

13. Documents to Send for the First Review

A useful first package normally includes a short project brief, product and capacity table, process flow diagrams, personnel and material flow notes, preliminary equipment list, site or building drawings, available photographs, target-market statement, desired schedule and a list of known constraints. Existing URS documents, utility data and approved equipment drawings should be included where available.

Use a document index and mark each file as approved, preliminary or reference. Remove confidential product or supplier details that are not necessary for the initial discussion, and confirm that the receiving team is authorized to view the material. If a document does not exist, list it as an open input rather than delaying the whole review. The result should be a focused workshop and a recorded action list for the next engineering stage.

A strong project start does not require every answer. It requires a visible project basis, controlled assumptions and clear responsibility for closing the most important gaps. GENO can review the available inputs, structure the first technical questions and define the next engineering steps. Applicable standards, deliverables, qualification support and commercial boundaries are then confirmed through the URS and contract.

Send Your Project Basis for an Initial Technical Discussion

Available information can be incomplete. Label assumptions, identify known gaps and share the documents that can support a focused first review.

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