10.5 Standard Operating Procedures & Document Control
Key Takeaways
USP <797> Section 17 requires written SOPs for the compounding process and its support activities, stating which CSP categories the facility prepares, and the designated person must make sure they are appropriate and followed.
The designated person reviews every SOP initially and at least every 12 months, documents the review, and is the only one who may change an SOP. Each change is documented and communicated, and staff should acknowledge it.
All personnel who compound or support compounding are trained on the SOPs, show competency in every procedure tied to their job, and are trained to recognize and report problems, deviations, failures and errors to the designated person.
USP <800> Section 17 separately requires hazardous-drug SOPs covering every situation where HDs are used, reviewed at least every 12 months by the designated person.
Good document control uses version numbers, effective dates, approval signatures, controlled copies, archived superseded versions and a link to training records.
10.5 Standard Operating Procedures & Document Control
Much of USP <797> is written as "as described in the facility's SOPs." The chapter sets minimum requirements, and the facility's SOPs turn them into the specific steps people follow each day. Inspectors therefore read SOPs first, then watch whether practice matches them. The BCSCP outline lists standard operating procedures as practice-management task 3B1.
USP <797> Section 17 requirements
- Facilities that prepare CSPs must develop SOPs for the compounding process and other support activities.
- The SOPs must state the types of CSPs prepared: Category 1, 2 and/or 3.
- A designated person makes sure the SOPs are appropriate and implemented. That includes making sure personnel show competency in every procedure related to their job.
- The designated person follows up to make sure corrective actions are taken when problems, deviations, failures or errors occur, and the corrective action is documented.
- Everyone who performs or oversees compounding or support activities is trained on the SOPs. Compounding personnel are trained to recognize potential problems (with equipment, facilities, materials, people, process or testing) and to report them to the designated person.
- SOPs are reviewed initially and at least every 12 months by the designated person to make sure they reflect current practice, and each review is documented.
- Only a designated person may change an SOP, and the change must be documented. Revisions are communicated to everyone involved, and personnel should document that they acknowledged the change.
USP <800> Section 17 mirrors this for hazardous drugs. The entity keeps SOPs for safe HD handling in every situation where HDs are used. The designated person reviews them at least every 12 months and documents the review, and revisions are communicated to everyone who handles HDs.
SOPs the chapters explicitly call for
| Area | Examples of required SOP content |
|---|---|
| Scope and special practices | Handling patient blood-derived materials (e.g., autologous serum); immediate-use CSP procedures |
| Personnel | Written training program; training for restocking and cleaning staff; garbing order and garb storage; disinfection of reusable goggles and respirators; RABS glove changes |
| Facility | Review of temperature and humidity readings; material movement and other risk areas |
| Certification and monitoring | Particle sampling sites; the microbiological monitoring program (sampling-site diagram, collection procedures, frequency, sample size, timing relative to activity, action levels); incubator temperature monitoring |
| Cleaning | Agents, frequencies, methods and locations; how long opened sterile agents may be used; documentation |
| Equipment and components | Calibration, maintenance, cleaning and use of equipment; the airborne-particle process assessment; selection, receipt, evaluation, handling, storage and documentation of components |
| Sterilization | Cycle parameters, loads, biological indicators and endotoxin challenge vials; training; verification schedule; equipment maintenance |
| Records and release | Approval of MFR changes; release testing; investigation of visual defects; labeling procedures |
| Quality | Roles in the QA program; recall of out-of-specification CSPs; complaint handling; adverse event reporting |
| Distribution | Handling, storage, packaging and transport of CSPs; temperature logs |
Anatomy of a good SOP
- Title, number, version and effective date
- Purpose and scope: what the SOP covers, and what it does not
- Responsibilities: who performs each step, who verifies, who approves
- Definitions of terms and abbreviations
- Materials and equipment needed
- Procedure: numbered steps, one action per step, with acceptance criteria and pictures where they help
- Deviations: what to do and whom to notify when something goes wrong
- Records: which forms or electronic records are completed
- References: USP chapters, state rules, manufacturer instructions
- Revision history and approval signatures
Write for the person doing the task. Use short sentences and specific numbers, such as "contact time 3 minutes" rather than "adequate contact time." Where timing matters, state it exactly.
Document control and change management
- Controlled copies: Only current versions are in use. Superseded versions are archived and marked obsolete, so staff never follow an old procedure.
- Change control: A proposed change is reviewed for its effect on training, equipment, validation, BUDs and other SOPs before approval. Examples include a new disinfectant, glove brand or ACD software version.
- Training linkage: A new or revised SOP triggers training and a competency check before the affected people perform the task. Training records reference the SOP version.
- Deviations: An unplanned deviation, where the SOP was not followed, is documented, investigated and closed with CAPA. A planned deviation is approved in advance for a specific, time-limited reason.
- Electronic systems: Electronic SOPs and records need access controls and audit trails. Outsourcing facilities under CGMP must meet FDA's electronic records rules (21 CFR Part 11).
Why this is tested
Many inspection findings are really SOP findings: no SOP for a required activity, an SOP never reviewed within 12 months, a changed practice without a changed SOP, or staff never trained on the current version. A BCSCP must be able to connect a USP requirement to the SOP that puts it into practice.
Under USP <797>, how often must a sterile compounding facility's SOPs be reviewed, and who does it?
Initially and at least every 12 months, by the designated person, with the review documented
Every 3 years, by the pharmacy director
Only when an inspector asks, by any pharmacist
Every 6 months, by the certification vendor
A lead technician wants to update the garbing SOP to match a new gown supplier. What does USP <797> require?
The technician may edit the SOP directly, since they know the process best
SOPs may not be changed between annual reviews
Any change must first be approved by USP
Only a designated person may change the SOP; the change is documented and communicated to affected staff, who should acknowledge it, and training follows as needed
Which content must a facility's SOP for its microbiological air and surface monitoring program include under USP <797>?
A diagram of sampling locations, collection procedures, sampling frequency, sample size, timing relative to compounding activity, and the action levels that trigger corrective action
Only the name of the certification vendor
Only the dates of the last two certifications
A statement that monitoring is done when time allows
Sections you finish are checked off in the contents.