Quality Control in Pharmaceutical Chemistry
Quality control is a critical function of any business offering a product or service to consumers. In the field of pharmaceutical chemistry, quality control and quality assurance are vital to the successful development, manufacturing, and use of drugs meant to help save lives.
Introducing Quality Assurance and Quality Control (QA/QC)
In the University of Florida’s online master’s degree in pharmaceutical chemistry, students are introduced to the basic principles of quality assurance and control (QA/QC). While quality assurance and quality control are sometimes used interchangeably, it is important to note that the fields of study do have different meanings.
Quality assurance involves the development and implementation of a system that provides confidence in a product’s quality and safety. It is achieved through planned and systematic activities implemented in a quality system to ensure the requirements for product development are fulfilled. Quality control is the act of controlling the processes associated with the product manufacture and evaluating product quality at various steps from raw materials to the final packaged product that reaches the consumer.
Quality Control and Quality Assurance in Action
Graduates with a master’s degree in pharmaceutical chemistry can help protect people from issues that arise during the development and manufacture of drugs.
Some recent pertinent examples that were highly publicized include:
- Valeant Pharmaceuticals: The company was forced to recall an inhaled medication used to treat hospitalized infants—because the final product was suspected to contain a microbial contamination.
- Avastin: An oncologist in the United States was forced to pay a $2 million fine and was convicted of a federal misdemeanor for using unapproved versions of Avastin—which is a drug used to combat cancer, but it is not approved for sale in the United States.
Quality assurance and quality control, while separate, are interdependent upon each other. When the evaluation of processes used in product development are determined through quality control, that feedback is provided to quality assurance professionals to ensure that the planned and systematic activities highlighted through quality control are implemented appropriately. The two approaches can be thought of simply as failure detection (QC) and failure prevention (QA).
QA/QC In the Workplace
A quality assurance audit at a pharmaceutical firm would focus on the process elements of a project. More specifically, a QA professional would determine if the requirements determined and defined during QA have the proper level of detail. QA individuals process the documentation, establish standards, and conduct internal audits to ensure continued compliance.
A QC professional, on the other hand, focuses on product elements. The individual would determine whether the requirements highlighted during QA implementation are the properly executed during regular production of the product. It is a QC professional’s job to perform inspections on products and conduct tests. Their information contributes to the quality assurance process. However, in many cases, the job title is something like QA/QC Manager, so there is a bit of both involved.
Preparing for a Future with a Master’s Degree in Pharmaceutical Chemistry
UF’s program is offered online to students, allowing distance learners and those already employed in the field the flexibility to return to school at their own pace. Within the master’s degree in pharmaceutical chemistry, students are introduced to quality assurance and quality control through the Laboratory QA/QC course.
Laboratory QA/QC presents key components of quality assurance and quality control to students in an effort to help them better understand the need to produce sound scientific data with appropriate standards and controls. Topics are introduced through 12 modules, ranging from validation of analytical procedures and test article tracking to study protocols and inspection and compliance.
With a master’s degree in pharmaceutical chemistry, graduates have the educational foundation needed to help ensure that drugs are designed and manufactured with the safety of consumers in mind, while also contributing to the ongoing safety of production processes.