QCQA Quality Control

What is the purpose of IPQC and process validation?

• To speed up the production process.

• To increase the shelf life of the finished product.

• To ensure the production of finished products of the required quality.

• To reduce the cost of production.

What are the requirements for reagents used in testing and assays?

• They should be prepared without following any specific procedures.

• They must have a certificate of analysis and material safety datasheet.

• They do not need to be labeled.

• They should be purchased from any supplier.

What is the purpose of reference standards (RS) in quality control?

• To increase the cost of quality control.

• To provide a standard for comparison.

• To increase the testing parameters.

• To prepare volumetric solution.

What is the purpose of traceability in the context of active substances?

• To increase the cost of production.

• To reduce the risk to the quality of the active substance.

• To fulfil the audit requirement.

• To ensure consistency in the testing process.

What should be included in the certificate of analysis for each batch of finished product?

• The results of all tests performed and the limits.

• The expiration date of the excipients used in the finished product.

• The name of the lab personnel who did the testing.

• The expiration date of the reagents used in the testing of the finished product.

What is the purpose of retaining samples of raw materials and finished products?

• To increase the storage cost.

• To complicate the disposal process.

• For future reference for troubleshooting product problems.

• As part of the audit requirement.

What is the responsibility of QC in the disposal of expired retention samples?

• To keep the expired samples indefinitely.

• To dispose of the expired samples after 5 years.

• To dispose of the expired samples according to the specified timeframes.

• To ignore the disposal of expired samples.

What should be done if a doubtful result (suspected OOS result) has been identified?

• The testing process should be reviewed before retesting is permitted.

• The test should be repeated immediately.

• The result should be ignored.

• The result should be rejected without any further investigation.

What is the purpose of retesting secondary and in-house reference standards?

• To avoid buying new standards.

• To ensure that deterioration has not occurred.

• To avoid using primary standards.

• To speed up the testing process.

What is the responsibility of the person handling reagents in the laboratory?

• To ignore the preparation and standardization of volumetric solutions.

• To ensure that the labels for reagent solutions are missing important information.

• To use unclean containers for the repacking of the reagents.

• Prepare the solutions as instructed in the protocol.