Role of Quality Assurance in Pharmaceutical Industry

What is Quality Assurance?

The role of quality assurance in the pharmaceutical company cannot be ignored.  It is a part of the Quality Management System, focused on providing confidence that the quality of the product and the system are fulfilled. The development of products in pharma and biotech is a vital role of quality Assurance. It is also a part of Good Manufacturing Practice GMP.

Quality Assurance is a step by step process of examining whether the goods and the services meet all specifications related to the quality, for the satisfaction of the customers.

It is a global threat having adulterated and poor quality medicine. After the 1957 Thalidomide disaster, the pharmaceutical industry saw a development in the performance and worth of a stringent, scientific, systematic and independent department to ensure the quality of the product.

Quality assurance is a system of specifications which is also referred to the system of standard operating procedures (SOPs) that are designed by regulatory authorities and the pharmaceutical industry to ensure good manufacturing practice (GMP). 

Quality Assurance and Quality Control.

• The quality management system consists of both Quality assurance and quality control.

• Quality assurance is aligned with process and it prevents the defects which can damage the quality of the process


• Quality control is aligned with the product and identify the defects.

Role of Quality Assurance in a pharmaceutical industry

1. Maintaining working environment:

Quality Assurance department in the pharmaceutical industry is responsible for maintaining environmental conditions and preventing environmental hazards. It can be achieved by

  • Identifying the hazardous material with material safety data sheet
  • Use of gloves, mask, protective clothes and glasses
  • Awareness of first aid and fire fighting application
  • Disposal of waste and rejected material

2. Identification and traceability

Quality Assurance department is responsible for the assurance of identification and traceability. Every status of product, process, machine, and equipment must be identified and recorded in a pharmaceutical company or an organization. Also, the Organization maintains the identification of Environment, Safety and Health Hazards.

3. Control of nonconformity

According to ISO 9001:2015 Clause 8.3, control of nonconformity is an important part of quality. If product, process, and system do not conform to the required results and deviate the specification then quality assurance of pharmaceutical company plays a vital role to control such kind of nonconformity. Records of nature of nonconformity and any subsequent actions taken are maintained. Any nonconforming product that has been re-processed is subjected to re-verification to ensure conformity to the requirements.

4. Internal Audits

Quality Assurance Department is responsible to establish a process for performing internal audits to determine if the Quality System conforms to the requirements of this international standard and has been effectively implemented and maintained.

The Organization plans audit program. An internal department of a pharma company is audited by other than the personals who are working in that particular department.

5. Continual improvement

Continual improvement of the pharmaceutical product and process is necessary for the satisfaction of the customer. Quality Assurance is responsible for continual improvement by conducting

Annual Product Review

Quality Management Review

Quality Risk Management

Quality Coordination Meeting

6. Corrective and Preventive action

In a pharmaceutical Industry quality assurance takes corrective and preventive actions if any nonconformity or deviation is observed in a system. The extent of corrective actions and preventive actions taken depends on the impact of the problems encountered. The procedure for the corrective action and preventive action process includes identification and review of non-conformities. Then the cause of non-conformities is determined.

Then the need for actions to ensure that nonconformities do not recur is evaluated and implemented. Whole procedure and action is recorded and follow up is taken.

7. Training

Quality assurance department in a pharmaceutical industry ensures the training of the employees to keep them upto date. Innovation in the system is a necessary part of the quality. For updated knowledge, the employees must be trained.

8. Calibration

A pharmaceutical industry must have calibrated equipment and instruments for good quality products. Quality Assurance department of pharma industry is responsible for the assurance of the calibration status of all equipment and instruments.

It is mandatory to have a separate calibration section in the quality assurance department, in many pharmaceutical industries.

9. Validation

Validation is a documented evidence to confirm that the specific requirements of a product, process or system have been fulfilled.

It ensures the quality of manufactured products and helps to manufacture the quality products.

Quality Assurance department in a pharmaceutical industry has a separate end to verify all the validation process.

10. Product Recall

Quality Assurance is responsible to initiate and entertain the procedure of product recall when critical quality defect is identified and confirmed. After finding any risk in the product which can be risky or lethal for the customers or can cause quality issue, an action is taken by the pharma company to recall the product. Quality assurance becomes the part of the team to recall the product and then to investigate the quality defect.

11. Customer satisfaction

Quality Assurance in the pharmaceutical industry is responsible to provide quality products. Therefore it is also responsible to provide satisfaction to the customers. Quality Assurance also deals with customer complaints and investigates them to rectify in the future.

12. Physical inprocess testing and sampling

From the receiving of raw material to process them and converting into quality finished good product, quality assurance is responsible for sampling and releasing at every step of the process. It is also called maintaining quality on the floor.

13. Control of document and record

Quality Assurance department of a pharmaceutical industry controls and handles all the documents and data. Every process in the pharmaceutical industry is properly documented and then archived by quality assurance.

It is almost obvious that the manufacturing of a pharmaceutical quality system is the responsibility of the Quality Assurance unit or department. This department has direct lining or reporting to senior management or executive level.  

Quality Assurance is a part of Good Manufacturing Practice. A pharmaceutical industry must have a well-developed and independent quality assurance department for    innovative vision of regulation that incorporates new thinking on manufacturing science, risk management, and quality systems