Labeling and Documentation Flashcards

When documenting a deviation from the Master Formulation Record, what is required?

Answer: The deviation must be documented with reason, approval by designated person, and impact assessment

Any deviation from the MFR must be formally documented including the nature, reason, approval, and impact assessment.

What is the role of Standard Operating Procedures (SOPs) in a sterile compounding program?

Answer: Mandatory written procedures that define how each process must be performed consistently

SOPs are mandatory written procedures required by USP 797 for every significant process.

What storage condition information is required on a CSP label?

Answer: Specific storage temperature range, light protection if applicable, and special handling requirements

CSP labels must include specific storage conditions including temperature range, light protection, and special handling instructions.

What documentation is required for environmental monitoring results?

Answer: All results must be documented, reviewed, and trended regardless of pass or fail

All environmental monitoring results must be documented, reviewed by the designated person, and trended over time.

What is the purpose of a recall procedure in a sterile compounding quality assurance program?

Answer: To establish a systematic process for retrieving all units of a potentially defective CSP

A recall procedure provides a systematic process for quickly identifying, locating, and retrieving all units of a CSP that may be defective or contaminated.

When a batch of CSPs is prepared, what batch-specific information must be recorded?

Answer: Batch number, quantity prepared, ingredient lot numbers, preparer identity, verifier identity, date/time, and yield

Batch compounding records must include comprehensive information for traceability.