Drafting SOPs for a Facility that Does Not Exist Yet

By Brian Strawn

When a biopharma company is bringing up a new manufacturing or warehouse facility, there are many standard operating processes/procedures (SOPs) that must be written during the facility’s construction and commissioning. These cover a range of critical areas, including materials receipt & storage, QC, issuance, production, packaging, and distribution. However, many organizations are unaware of the appropriate time to begin drafting relative to the construction schedule.We often encourage our clients to perform a Gap Analysis and begin drafting SOPs as early in the design phase of the construction project as personnel and Quality systems infrastructure permit.

Drafting SOPs Early Ensures Compliance

In the FDA’s Code of Federal Regulations (CFR), the guidance on written procedures for production and process controls for finished pharmaceuticals is intentionally vague (see excerpt from Title 21, Volume 4, Part 211, Subpart F, Section 211.100 below), as are most sections of the CFR. Each organization, and the industry at large, is responsible for determining what constitutes the “current best practice” for cGMP production. It is incumbent on the FDA and other global agencies to confirm that your corporation aligns with these standards.

Subpart F – Production and Process ControlsSec. 211.100 Written procedures; deviations.

(a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit.

(b) Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified.

(current as of 7/5/2024)

Benefits of Drafting SOPs Early Beyond Compliance

Drafting SOPs sooner rather than later in the construction cycle is very helpful because many of the questions raised and the decisions made during a Gap Analysis and/or SOP writing project help determine how to design and construct your facility. Like a process mapping initiative, drafting procedures forces cross-functional thinking and coordination between departments to define business processes. In doing so, it often highlights constraints and points of disagreement, clarifies and defines responsibilities, and drives alignment across functional teams.

Over the course of several engagements, we found that drafting procedures can uncover a need for changes to facility designs and material/personnel flows to accomplish Supply Chain and cross-functional department goals.

In one example, activities and delineation of duties identified during SOP development prompted our client to rethink their forecast for staff requirements in each department. Hiring too early or too late can have damaging effects on your year-over-year budget and your capability to support the overall business. These changes, if highlighted early enough, can drive adjustments when they are easier to implement, and enable teams to make the most efficient use of facility space and personnel for each task.

Ultimately, these procedures will be revised again and again as the process is refined, so perfection on Rev.0 is not necessary. It is also unlikely agencies will penalize you for starting a basic documentation framework too early, but their observations will certainly highlight when you are too late. Defining and documenting processes in line with the progress of clinical and commercial phases is key to cGMP compliance.

Key Takeaways & Recommendations

• Proper documentation of your manufacturing and GMP warehouse activities is required for compliance. It must be in place for clinical and commercial operations.
• Begin drafting SOPs as early in the design phase of the construction project as personnel and Quality systems infrastructure allows.
• Use the discussions and coordination required for drafting SOPs to highlight pain points, identify areas of disagreement, and build alignment on roles and responsibilities.

If you are looking for support with drafting SOPs for starting up your own facility, our experts are here to help. Start the conversation by reaching out to 857.245.7125 or info@convergeconsulting.com.