Quality Assurance & Quality Control Notes

This set of flashcards is based on key concepts from the Quality Assurance and Quality Control lecture notes, useful for exam preparation.

What is the definition of quality in terms of product features?

Totality of features or characteristics, conformance to specifications.

What does specifications refer to in the context of quality assurance?

List of detailed requirements with which the product has to conform.

What is cGMP?

Current Good Manufacturing Practice ensuring products are produced and controlled to quality standards appropriate for intended use.

Which GMP does the Philippines follow?

PIC/S GMP (Pharmaceutical Inspection Convention and Pharmaceutical Cooperation Scheme).

What is included in Quality Control (QC)?

Sampling, testing, specifications, organization, documentation, certificate of analysis and release procedure.

What is the difference between Quality Assurance (QA) and Quality Control (QC)?

QA assures all policies are followed, while QC involves testing for compliance and monitoring procedures.

What is a Certificate of Analysis (COA)?

Summary of actual quality control results indicating whether a product is compliant or non-compliant.

What is the purpose of inspection in quality control?

To compare attributes and dimensions against a standard.

What does sampling entail in the context of quality control?

Removal of an appropriate number of items from a population to infer about the entire population.

What does the term 'defective' refer to in quality control?

A product that may endanger life, renders it useless and non-functional.

What are the three types of defects according to their effects?

Critical, Major, and Minor.

What is the role of quality control charts?

Aid in controlling and analyzing parameters to detect variation in the process.

What are warning limits in quality control?

Mean ± 2 Standard Deviations (SD); used for monitoring closely.

What are action limits in quality control?

Mean ± 3 Standard Deviations (SD); signal to stop operations and perform Root Cause Analysis (RCA).

What is the role of the Quality Control department?

To release products based on compliance to quality standards.

What is the main function of 'sampling' in quality control?

To assess the quality of a batch by inspecting a representative group.

What is the difference between 'qualitative' and 'quantitative' analysis?

Qualitative analysis identifies what is present; quantitative analysis measures how much is present.

What is the significance of the accuracy in analytical chemistry?

Closeness of test results to the true value.

What does compressibility index indicate?

It measures how a powder decreases in volume under pressure.