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1. CHECKLIST
Production Checklist for Biotech Startups
Whether you are getting started or you are revamping your systems or processes,
this list can keep you on track and organized. These tasks are for high level
planning.
The intent is for managers to thoroughly analyze every task upfront and to plan for the worst-case scenarios. This
means to pursue the risk-averse approach where quality and safety is at the forefront of every decision.
Additionally, the recommendations on this list invests in comprehensive solutions rather than decisions that result
in temporary or partial, quick fixes. They key is to do it right the first time rather than suffering the expense that
results from an unstable decision (e.g., loss of research, products, labor, personnel, equipment, or legal and public
repercussion).
We wish the best in your journey ahead, and we hope to contribute to your company’s accomplishments and
successes!

2. Core Planning
☐ Define corporate goal: Manufacture safe and efficacious products according to GMP (good manufacturing
practice).
☐ Prepare document for local authorities who will ask about the intent of the facility and how it will impact
the community.
☐ Develop a scope statement for investors including deliverables and SMART objectives. (SMART=Specific,
Measurable, Achievable, Relevant, Time-Bound)
 Identify the bounds of the investment funds.
 Identify the funds that are available in the beginning for engineering, preconstruction, build out, and
continuous quality verification (CQV).
 Identify a timeline for investors, which includes phases of construction required for operation.
☐ Create a control log for each phase of the project signed by CEO and CFO. Include:
 change order
 cost impact
 schedule change
 cash flow change
Preconstruction / Needs Analysis
☐ Assign quality assurance (QA) manager to synchronize with suppliers, vendors, and builders to identify
regulation requirements for systems, equipment, facilities, etc.
☐ Assign specialists to create user requirement specification (URS) for facility and equipment. Include
requirements below:
 Engineering
 QA
 Quality control
 Operations
 Productions
 Logistics
 Legal representation
 Responsible person
*See Appendix I: URS
☐ Consolidate URS content into one document.
☐ Perform risk analyses and rate potential risks.
 Describe how critical a function is to the system’s overall ability to perform properly.
 Describe how easy it is to detect an error with a particular function.
 Describe the probability of an issue arising with a particular function
☐ Schedule engineers and/or suppliers to establish the functional specification, which describes what the
system must do–sequence of operations for every process based on URS.
Tip: Hire a larger engineering firm because they have credibility with vendors. Also, if you have to delay
payment, larger firms are able to stop and return to projects because they have financial backing, but
anticipate the original project team to be reassigned during that delay.
☐ Schedule a different large, top-tier construction firm to establish the design specification, which describes
how the system performs the function. The firm will cross check the engineering firm on building costs, the
concept of the incremental build, the execution, the techniques, and the schedule.
Note: There is a great risk to scheduling multiple projects simultaneously. When there are budget
complications, projects are halted at once, leaving plants incomplete and inoperable. By scheduling one
project at a time (smaller expenses), you can reasonably expect the completion and operation of a unit.

3. However, building projects independently will cost more upfront because of the added expense of
remobilization.
 Define individual scope sections that can be executed separately.
 Price the individual sections for future inclusion, delay, or deletions (every process suite, parallel
process, and redundant system).
 Select and size all the large equipment (e.g., WFI skid, HVAC AHUs, backup generator, autoclave,
etc.) and get it on order. This can cut the build cycle time by months.
 Create greater than +/- 25% estimate with multiple capital deferral options.
 Once detailed design is started, collect early release drawings and documents for the next critical
path items (typically the architectural features).
 Schedule each critical path discipline for release in its order in the project’s critical path.
☐ Estimate cost of suppliers.
Note: All equipment suppliers will require 50 % of the purchase price upon purchase order, regardless of
delivery date, and the final 50 % within 30 days of delivery.
☐ Estimate major equipment delivery time.
 Identify the latest date that funds can be committed and still meet the project timeline.
 Place the purchasing deposits.
 Confirm delivery dates.
Note: Anticipate delayed deliveries from major equipment suppliers who prioritize larger clients.
☐ Schedule the build.
☐ Schedule factory acceptance test (FAT).
☐ Schedule site acceptance test (SAT).
☐ Schedule CQV activities.
Note: Anticipate delayed or canceled start-up and CQV services because vendors prioritize servicing larger
clients.
☐ Estimate cost of designer.
☐ Schedule designer.
☐ Perform and document design qualification (DQ), which lists-line by line how each requirement of URS is
met.
☐ Estimate cost of builder (different from designer).
Construction
☐ Complete build
☐ Document and complete qualifications and validations of equipment, room, system, fleet,commissioning.
 Installation qualification (IQ)
 Operation qualification (OQ) / factory acceptance test (FAT)
 License approval (i.e., audit)
 Performance qualification (PQ) / site acceptance test (SAT)
☐ Define packaging and delivery logistics requirements.
☐ Define marketing and selling requirements.

4. Appendix I: URS
The URS is the bases for building the system. It describes what must be achieved, not the details of how it is achieved.
It forms the evaluation criteria for the system’s success. The following is an outline of information that could be
included in your URS.
System Description (insulated wall, roof, floor; lights; refrigeration skids and piping)
Process Requirements
 Capacity
 Purpose
 Quality attributes
 Security
 Performance
 Modifiability
 Reliability
 Usability
 Automation and records / data
Design and Construction Requirements
 Mechanical
 Control sensor accuracy
 Control panel
 Temperature
 Size
 GMP standards
 Automation and Records
 Environmental monitoring system
 Building management system
 Automated control system
 Utilities
Tip: Leverage the construction firm’s contacts and relationships with the heavy infrastructure vendors
(HVAC, boilers, chillers, etc.). They should be able to secure the best delivery and cost. The same goes for
leveraging the design engineer’s connections and contacts for various plant equipment.
 Internet (network, cloud)
 Electrical
 Backup power
 Voltage
 Wiring
 Light
 Air
o Temperature
o Particles count
o Humidity
o CO2 in incubators
o Pressure, pressure differential
 Water
 Waste
 Sewage

5.  Environmental Health and Safety (EHS) Requirements
 Noise level
 Refrigerant monitoring
 Process parameters, definition of biosafety levels: BL-1, BL-2, or BL-3 of any organisms and OSHA
classification of any potent compounds
 QA education and orientation of the scientific core of the company
 EHS responsibilities for compliance and regulation, safety/biosafety, biosecurity, OSHA, and the
do’s and don’ts of a construction site
 SOPs
 Operations and Maintenance Requirements
 Sensors must be installed in order to facilitate routine calibration
 SOPs (storage, temperature, equipment alarms)
 Hardware maintenance
 Personnel
 Cleaning
 Capacity (maximum and minimum)
 Design layout
 Workflow arrangement
 Distribution
 Potency, number of doses in the therapy, product yield, product presentation, etc., how many
clinics and patients at all phases will need to be served
 Ability/future plan to scale up
 Maximum use of single use systems (SUS) to provide for future flexibility (Most biotech processes
are composed of multiple processing skids and use disposable technologies to varying extents. It
is at this point that two decisions need to be made:
 Select and place on order the major systems (bioreactor skid(s), TFF skids, chromatography
systems, etc.) that provide the required scale either as a single unit or as multiples of smaller
units (to accommodate incremental cost-effective scale-up).
 With the key equipment and their costs defined, the project can shorten or potentially
eliminate the basis of design (BOD) stage.