Industrial Pharmacy · Short notes

Quality Control and Quality Assurance: Short Notes & Cheat Sheet

QA versus QC, sampling, OOS investigations, batch release, quality tools such as PDCA, control charts and fishbone diagrams, and product quality review.

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Short notes

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The PDCA cycle

1PlanIdentify the problemand a fix2DoTry the change on asmall scale3CheckMeasure whether itworked4ActStandardise it, or planagain
After 'act', the cycle starts again at 'plan', so improvement never stops.

QA versus QC

  • Quality assurance is the whole system (including GMP and QC) that prevents defects. It is proactive and process-focused.
  • Quality control is sampling, testing and inspection to detect defects. It is reactive and product-focused.
  • QC tests raw materials, packaging materials, in-process samples, finished products and stability samples.
  • A common sampling plan for incoming material containers is √n + 1, where n is the number of containers.
  • QA reviews the batch documents and test results before the batch is released for sale.

Investigations and documents

  • Out-of-specification (OOS) results are investigated in phases: first a laboratory check for obvious errors, then a full investigation of manufacturing if no lab error is found.
  • Results cannot simply be retested until they pass ('testing into compliance').
  • Out-of-trend (OOT) results are still within limits but unexpected, and also need attention.
  • Reference standards are primary (official) or secondary (working standards qualified against a primary).
  • A certificate of analysis records the test results for a batch. The annual product quality review looks at all batches for trends.

Quality tools

  • PDCA (Deming) cycle: plan, do, check, act, then repeat for continuous improvement.
  • Control charts plot results against a centre line with control limits at the mean ± 3 standard deviations.
  • The fishbone (Ishikawa) diagram groups possible causes, often under the 6 Ms: man, machine, method, material, measurement and mother nature (environment).
  • Pareto analysis focuses on the few causes behind most problems (the 80/20 rule). Six Sigma aims for 3.4 defects per million opportunities.
  • ICH Q10 describes the pharmaceutical quality system; ISO 9001 is a general quality management standard.

Cheat sheet

High-yield facts in one place. Cover the right-hand column and test yourself.

QA vs QC

AspectQA · QC
FocusProcess, prevention · product, detection
ApproachProactive · reactive
ScopeWhole system incl. GMP · testing and inspection
Example activityBatch release, audits · assays, dissolution

Quality tools

ToolUse
PDCA cycleContinuous improvement
Control chartDetects when a process drifts
Fishbone (Ishikawa)Root-cause brainstorming
Pareto chartPrioritises the biggest causes
Six Sigma3.4 defects per million
√n + 1Number of containers to sample

Memory aids

QA Avoids, QC Catches
Quality assurance prevents defects; quality control detects them.

Exam traps

  • QC is part of QA, not the other way round.
  • Retesting an OOS sample until it passes, without a justified cause, is not acceptable.
  • Control limits on a Shewhart chart are usually ± 3 standard deviations, not ± 2.
  • An OOT result can be within specification and still need investigation.

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