The Role of Quality Assurance in the Pharmaceutical Industry

Quality assurance is a wide concept that covers all aspects that collectively or individually impact the quality of the product. That is, the sum of organized arrangements that are made with the aim of ensuring pharmaceutical products are of the required quality as per the intended use.

Quality assurance is a good practice in the manufacture of pharmaceutical products, as it is the process of vouching for integrity of products to meet the standard for the proposed use. It is an obligation that ensures manufacturers meet the needs of end-user needs in terms of safety, quality, efficacy, strength, reliability and durability. Quality is a benchmark of perfection for the end-user.

An Overview of the quality assurance department in pharmaceutical industry

The surge of substandard, fake and adulterated medicine is global threat. The pharmaceutical industry saw an increase in regulation after the 1957 thalidomide disaster. The stringent, scientific, systematic and sustainable approach to commercial drug production ensures protection of public health.

The system of specifications as well as practice control measures in the industry, which is also referred to as standard operating procedures (SOPs) that are designed by regulatory authorities and scientific community to ensure good manufacturing practice.

Quality Assurance as Caretaker of the Pharmaceutical Quality System

Although it is almost obvious that the formation of a pharmaceutical quality system is the sole responsibility of the quality assurance unit or department, a majority of the required elements that are seen to be duties of quality assurance may be implemented through a networked organization that incorporated suitable specialized departments. As such, they may be handled under the umbrella of other functions.

Thus, the best way of dealing with it is through a quality assurance department or unit as a global function that has a direct line or reporting to senior management or executive level. Quality assurance would therefore focus on provision of suitable systems as well as defining them in SOPs and higher level instructions on provision of appropriate information.

Quality assurance preparing the groundwork for certification by the qualified Person

The function of the quality assurance department can be understood and shaped while placing emphasis on the operational aspects. This may be helpful to appreciate the role of quality assurance as including preparation of data for the Qualified Person for the purpose of batch release and certification. In this case, the quality assurance organization would then take up the task of generating portions of batch-related data to ensure they are available through appropriate reporting systems as well as parallel so as to guarantee the functionality of standard quality systems. The division of labor between quality assurance, quality control and heads of production involves a hierarchical equivalency.

Quality on the Floor

Breaking down the central function of a quality assurance unit and delegating to employees in the other operation departments especially in production, makes sense particularly in larger and highly specialized organizations that have long connecting pathways.

This means they would be available as contact persons around to ensure quality on the floor. Consequently, it is mandatory for quality employees to be provided with the right decision making authority giving a guarantee for short decision routes.

For operational unit managers and quality managers to be equal partners, employees must have well founded special knowledge of workflows within the operational unit.

Objectives of Quality Assurance

Quality assurance exists to serve a number of objectives that include the following:

  • To offer a guarantee that the person who is administering medicine is confident that every unit will achieve the desired effect.
  • To protect users for products from possible accidental defect in the manufacture, design, storage as well as usage instructions.
  • To ensure the law is complied with to the latter.
  • To offer protection of the manufacturing organization.

Product and Safety Liability

More and more manufacturing companies are getting accustomed to the full impact of strict product liability. This is enhanced by the introduction of the new product liability legislation within the developed world. The effect of this in the industry is that all businesses that need to continue trading profitably must take into account safety oriented procedures that will keep product liability risks at a minimum.

Quality assurance is a management tool that is recognized widely as a means of executing product liability prevention programs that are effective. Thus, companies that ignore the dangers are likely to suffer serious financial peril.

Calibration services are a vital component of quality assurance. RS calibration plays an important role in various aspects of quality assurance in pharmaceutical industry, such as good manufacturing practice, product releases as well as commercial implications. They play the role of a sentinel, ensuring adherence to regulations as well as identifying possible shortfalls and making recommendations for improvements that may be made over time.

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