Quality assurance is the one factor that pharmaceutical manufacturers can’t take granted for. Without appropriate quality check, companies cannot give an assurance that their products comply with safety standards.
While everyone working in an organization is equally answerable to maintain quality standards, the upper level management specifically is responsible as they need to provide adequate training to their employees to adhere to strict quality guidelines.
Quality Assurance Principles in Pharmaceutical Sector
Quality assurance based on ISO 9001 deals with providing assurance that the prerequisites for quality are satisfied and involves 8 basic principles.
These 8 preliminary principles focus on:
- Leadership
- Worker’s contribution at all levels of organization
- Administration of different resources
- Support for constant improvement
- Implementation of system’s approach
- Adopting factual approach to make right decisions
- Customer satisfaction
- And setting up supplier relationships that are mutually beneficial for the supplier and the organization
The Dedicated Quality Assurance Department
As discussed above, all staff within an organization is responsible to comply with preset quality standards and guidelines. Senieer – Pharmaceutical Equipment Manufacturer in China suggests that the dedicated quality assurance department within an organization is a guarantee that there will be a team who’s responsible to look after all the matters of quality control and management within an organization. It’s organization’s responsibility to hire competent and proficient staff with good communication skills to review ongoing procedures and conclude whether or not they are in line with the preset quality measures.
The Quality Assurance Manager
A pharmaceutical manufacturing company cannot perform well without an experienced and professional quality assurance manager. These managers make use of ISO 9001 to make sure that documentation related to the quality assurance comply with the regulations and are maintained and updated on regular basis. Also, they ensure that the staff hired within an organization is properly trained with suitable qualifications and all activities carried forward within an organization are matching up with the quality standards regulated by the authorities.
The role of quality assurance managers isn’t confined to basic analysis only. Apart from making routine assessments, these individuals are also responsible to keep track of quality documents and job descriptions of employees. Also, they should monitor the performance of the auditing system and ensure that the system is in place to share audit results.
Promoting awareness of quality assurance procedures is also a duty of quality assurance managers.
The Role of Pharmaceutical Executives in Pharmaceutical Industry
One significant attribute of quality assurance is that it should pair up perfectly with your business model and objectives. The role of executives is to affirm that their upper level management is committed to establishing and improving effective quality systems.
Thus, they must prepare a suitable quality policy to ensure that all workers understand those guidelines. Also, they must ensure that the established procedures meet the requirements of the clients and organizational long-term objectives.
This simple yet highly effective guide will help manufacturers take suitable quality measures in order to improve the quality of their final products.