Difference between QA and QC Department.

Difference between QA and QC Department 

Quality assurance and Quality control both terms seem very similar in general but are very different in view of the roles they play in a company. In pharmaceutical manufacturing companies, both  QA and QC have predefined roles and functions. These are not synonyms for each other but these two have a very defined and significant area of functioning. According to the working area, there is a lot of difference between the QA and QC department. 

However, both departments QA and QC work to maintain the quality of pharmaceutical products. But the area of function is totally different from each other.

Functions of Quality Assurance

The Quality Assurance department is the main vigilant quality care in any pharmaceutical company. The role of the QA department starts much earlier than other departments in the company. In fact QA department has to start working as the work of the building starts to ensure the implementation of Schedule-M norms in building construction. 

 The Quality Assurance department gives directions to the contractor to follow the schedule-M guidelines specified for the plant. 

The installation of the HVAC system and AHU during the construction of the building is also guided by the QA section. 

Every machinery in the production and utility section is also installed under the guidance of QA. department following the guidelines of Schedule-M and complying with the uniflow of the product manufacturing process. 

Quality Assurance is responsible for preparing the SOPs for all manufacturing processes, analytical processes, production machinery, Laboratory instruments, Utility machinery, etc. 

The quality Assurance department prepares Master Formulas for every product going to manufactured in the company with the association of the production department. 

 The quality control department also ensures every Drug Regulatory Affairs-related document including Drug Manufacturing Licences, GMP, WHO-GMP, ISO, MHRA, USFDA, etc. 

QA department observes every activity that happens in the company process including incoming Raw materials, Laboratory Chemicals, etc. 

QA department ensures that every manufacturing activity should be followed by proper documentation.

QA department ensures every analytical process should be documented with valid points. 

Functions of Quality Control

The quality control section in the pharmaceutical manufacturing company is the main executive department that ensures the output of quality products. It is the department that does the analysis of Raw materials, finished products, and in-process products and prepares the documentation for every activity done by the QC department. The following significant responsibilities of the QC department are listed here:-

 The quality control department is responsible for following the SOP set by the QA department for the QC section. 

It is responsible for the analysis of every incoming raw material in the company.

QC Department is responsible for the analysis of every in-process testing of products in the under-manufacturing process. 

QC Department ensures the analysis of every finished product before releasing it for sale in the market. 

They also maintain the logbooks and supporting documents for the testing done for future reference to establish the validity of the testing process. 

Different types of documents are also prepared by the QC department along with analysis of items including the COA of Raw material, COA of Finished products, Validation record for the analytical processes, Calibration of instruments, Standardization of reagents, usage logbook of every instrument, etc. 

QC department is responsible for the stability studies of products, and for maintaining the relevant record. 

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