GMP Principles of SOPs: Practice Test

Answer: To provide written instructions that ensure a process is performed consistently and in compliance with regulatory requirements.

Explanation: Under 21 CFR Part 211.100 and Part 820, manufacturers must establish and maintain written procedures for all operations that could affect product quality. SOPs are regulatory requirements, not internal preferences. An SOP that exists but is not followed is itself a finding during FDA inspection.

Answer: The cost of the process being described.

Explanation: Required SOP elements under GMP include purpose, scope, responsibilities, materials and equipment, step-by-step procedure, acceptance criteria, and references. Financial or cost information is not a GMP requirement. Common additions include revision history and definitions, but these are driven by quality system design rather than regulatory mandate.

Answer: A deviation from an approved SOP has occurred, and the product may have been released without completing a required quality step.

Explanation: Under 21 CFR Part 211.100, written procedures are required and must be followed. An operator’s personal judgment does not override an approved SOP. The deviation must be documented, investigated, and assessed for impact on product quality before batch release. Releasing product without this assessment is a significant GMP violation and could constitute adulteration under the FD&C Act.

Answer: FDA GMP regulations do not specify a fixed review interval. The manufacturer must define a review frequency appropriate to their quality system.

Explanation: While FDA does not mandate annual reviews, most quality systems establish periodic review cycles of one to two years. ISO 13485:2016 similarly requires documents to be reviewed and updated as necessary. An SOP that does not reflect current practice is a documentation deficiency that inspectors frequently identify.

Answer: The revised SOP must be reviewed, approved through formal change control, and all affected personnel must be trained on the new version before it is placed into use.

Explanation: Change control is a fundamental GMP requirement. Revising an SOP and placing it into production use without change control approval and confirmed training is a GMP violation. Under 21 CFR Part 211.100 and ISO 13485:2016, procedures must be approved before use.

Answer: The obsolete version must be removed from all points of use and either archived or destroyed according to the document control procedure. It must be clearly identified as obsolete.

Explanation: A common inspection finding is an old SOP version still posted at a workstation or accessible alongside the current version. The document control system must ensure only current approved versions are available at points of use.

Answer: A documented risk assessment is required to determine whether the change is within the validated range. Revalidation is required if the change could affect product quality outside the existing validated space.

Explanation: Under 21 CFR Part 211.100 and FDA process validation guidance, changes to manufacturing processes require evaluation of their impact on product quality and validated state. A 5% compression force change may or may not require revalidation depending on the original validation range. The risk assessment and any required validation studies must be completed before the new SOP is approved.

Answer: Before performing any task covered by the SOP for the first time, and whenever the SOP is revised in a way that affects their role.

Explanation: Under 21 CFR Part 211.68 and Part 820, employees must be trained to perform their assigned functions. Training must be documented and must occur before the employee performs the task independently. When an SOP is revised, affected employees must be retrained before the new version takes effect.

Answer: The site may not be fully compliant. If the 2 untrained employees have performed the relevant tasks without training, a deviation exists. If they have not performed the tasks, a risk assessment may be sufficient.

Explanation: GMP training requirements do not permit exceptions based on convenience. Employees on leave should be trained upon return before resuming relevant duties. Training records must document the specific SOP version on which each employee was trained.

Answer: Training confirms that an employee has been exposed to and understands the procedure. Effectiveness verification confirms that the employee can correctly perform the procedure in practice.

Explanation: Reading an SOP and signing a training record demonstrates exposure, not competency. Many quality systems require effectiveness checks: direct observation, written assessments, or practical demonstrations. FDA inspectors increasingly ask not just whether training occurred, but whether it was effective.