Quality Control & Process Improvement Flashcards

Under FDA cGMP regulations for dietary supplements (21 CFR Part 111), how long must manufacturers retain batch production records?

Answer: 1 year past the product's expiration date or 2 years from distribution, whichever is longer

21 CFR Part 111 requires batch records to be kept for at least 1 year beyond the product expiration date or 2 years from the date of distribution, whichever is longer.

Which quality metric measures the proportion of products that meet specifications on the first production attempt without any rework?

Answer: First Pass Yield (FPY)

First Pass Yield quantifies manufacturing efficiency by tracking the percentage of units meeting all specifications without requiring correction or rework.

A nutritionist recommends a probiotic supplement to a client. Which quality attribute is most critical to verify given that probiotics contain live microorganisms?

Answer: Microorganism viability at the time of consumption

Probiotic efficacy depends on live organism counts at the time of use, so stability data confirming viability through the expiration date is essential.

In quality management, what distinguishes a 'preventive action' from a 'corrective action'?

Answer: Preventive actions are taken to eliminate potential problems before they occur; corrective actions fix problems that have already happened

Corrective action responds to identified non-conformances, while preventive action proactively addresses potential issues before they manifest.

Which approach to quality management emphasizes ongoing, incremental improvements involving all employees rather than large-scale periodic overhauls?

Answer: Kaizen

Kaizen is a Japanese philosophy of continuous, incremental improvement where every employee at every level contributes to process enhancement.

When a dietary supplement company receives a consumer complaint about a foreign object in a product, which quality system element should be activated first?

Answer: Initiate an investigation using the complaint handling procedure and retain the sample if available

Formal complaint handling procedures require documenting, investigating, and retaining complaint samples to determine root cause and prevent recurrence.

Which International Organization for Standardization (ISO) standard provides a framework for establishing and maintaining a Quality Management System applicable to supplement manufacturers?

Answer: ISO 9001

ISO 9001 sets the internationally recognized criteria for a Quality Management System, applicable across industries including nutraceutical and supplement manufacturing.