Quality Assurance : The Act Of Giving Confidence

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The phrases “quality assurance” and “quality control” are frequently used interchangeably to refer to methods of ensuring the quality of a service or product. These phrases, however, have different meanings.

Assurance: The act of giving confidence, the state of being certain or the act of making certain.
Quality Assurance: The planned and systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled.
Control: An evaluation to indicate needed corrective responses; the act of guiding a process in which variability is attributable to a constant system of chance causes.
Quality Control: The observation techniques and activities used to fulfill requirements for quality.”
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Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
Operators are trained to carry out and document procedures.
Cross contamination with unlabelled major allergens is prevented.
Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations are investigated and documented.
Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
The distribution of the food or drugs minimizes any risk to their quality.
A system is available for recalling any batch from sale or supply.
Complaints about marketed products are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective products and to prevent recurrence.
Practices are recommended with the goal of safeguarding the health of consumers and patients as well as producing good quality food, medicine, medical devices, or active pharmaceutical products. In the United States, a food or drug may be deemed "adulterated" if it has passed all of the
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