Appropriate quality assurance is important in the pharmaceutical industry. Without it, companies cannot guarantee that their products conform to the appropriate standards for quality and safety.
Although everyone in a company is ultimately responsible for quality, executives and other members of top management have an important responsibility to provide training and foster an environment that promotes teamwork and emphasizes quality.
Although pharmaceutical companies may delegate responsibilities to other entities, such as contract research organizations, the responsibility for quality assurance ultimately rests on them. As such, it is important for pharmaceutical executives to understand the importance of maintaining quality assurance systems and the most effective path to managing
Principles of Quality Assurance in the Pharmaceutical Industry
Based on ISO 9001, quality assurance is concerned with providing confidence that the requirements for quality are fulfilled and consists of eight principles.
These eight principles consist of a focus on customer satisfaction, an emphasis on leadership, involvement of personnel at all levels of the organization, management of activities and resources as a process, adoption of a systems approach to management, facilitation of continuous improvement, use of a factual approach to making decisions, and establishment of supplier relationships that are mutually beneficial.
The Quality Assurance Department
Although all personnel in an organization are responsible for quality, the quality assurance department is primarily responsible for conducting quality assurance tasks and providing system that is both effective and efficient.
A good quality assurance department should be staffed by appropriately qualified personnel with good interpersonal skills. The department should operate independently from the other departments and must regularly review quality by performing audits to ensure that the regulations are being followed.
The Quality Assurance Manager
Good quality assurance managers are integral to the smooth operation of a quality assurance department.
These managers use the principles ISO 9001 to ensure that quality documents that conform to the regulations are developed and maintained, personnel are qualified and appropriately trained, and all activities are conducted according to the appropriate corporate and regulatory standards.
They also ensure that a system is in place to track and keep a record of quality documents, the job descriptions of personnel are current, a system is in place to track each employee, and an auditing function is in place to identify mistakes and correct them.
He or she must monitor the effectiveness of the auditing system and make certain that a mechanism is in place to share findings from audits, promote auditing in tandem, and track audits.
Quality assurance managers are also responsible for promoting awareness of procedures that promote quality assurance.
This includes ensuring that appropriate standard operating procedures are in place. These standard operating procedures should ensure that clinical trials are conducted in accordance with Good Clinical Practice and other regulatory guidelines, products are manufactured in accordance with Good Manufacturing Practices, and assays are conducted in accordance with Good Laboratory Practices.
Responsibilities of Pharmaceutical Executives
One important aspect of quality assurance is that it should match the objectives and business model of the company. Executives should ensure that their top management personnel are committed to and actively involved in establishing and monitoring effective quality systems.
They must define and document an appropriate quality policy and quality objectives. They must also ensure that all employees understand those policies and objectives. They must also make certain that the processes meet the needs of the clients and the objectives of the company.
Executives should define the responsibility of key personnel, such as the head of the quality assurance department, in managing quality systems. They should make certain that the appropriate personnel periodically review the quality systems to make certain that they are still appropriate and effective.
Taking these steps will help to ensure that the products that a company manufactures are safe and of high quality.
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