Quality Assurance Department Functions in Pharmaceuticals

Quality Assurance FunctionsQuality Assurance Department Functions in Pharmaceuticals : Quality Assurance Department shall function for assuring the quality of all the Products manufactured, at every stage of manufacturing / processing of Drug Products.

This shall be achieved by performing the functions of monitoring as per the laid systems for the following areas which is not limited to this:

Quality Assurance Department Functions are listed below :

  • Ensuring proper warehousing practices (Quality Assurance Function 01)

    • For Incoming components (Active Pharmaceuticals Ingredients) –
      • API,
      • Excipients,
      • Packaging Materials,
      • containers and closures,
    • labels with proper storage conditions which is required for drug stability, etc.:- QA department is responsible for the proper storage of API and other excepiants and segregation of the material in the warehouse.
  • Manufacturing process and critical process checks (Quality Assurance Function 02): –

    • This is one of the most critical activity performed by the QA department.
      • For this Activity special team is assigned named as IPQA (In Process Quality Assurance). Which keep a eye on all floor activities related to the Storage of RM to the final product dispatch,
        • Before starting any manufacturing process the IPQA person ensure the paperwork and physical condition of the area
          • where the product is going manufactured during the manufacturing of the product several samples are collected by IPQA for testing to ensure the quality of the product during the manufacturing process.
  • Process monitoring and Process controls (Quality Assurance Function 03):-

    • During the manufacturing of the product the whole process is monitored by the QA department and
      • ensure that all the steps followed for the manufacturing of the product are validated and as per SOP.
      • If the QA person is found any alteration in the method of manufacturing of the product then the appropriate action is taken to ensure the quality of the product
  • Batch Record Review (Quality Assurance Function 04) :-

    • All the data which is generated during the manufacturing of the Pharmaceutical product is recorded in a file ( soft copy / Hard copy).
      • Which tell us about the all essential data related to product manufacturing ( e.g.- Timing of process , ingredients ,environmental conditions, person involve etc), in the end of the manufacturing process
      • QA person review the batch record to ensure the data enter in the batch record is legible if QA person found any kind of data integrity issues then the appropriate action is taken as per the SOP.
  • Final release of Drug Products for distribution and sale.:-

    • When the Pharmaceutical product is manufactured and Packed then the role of QA comes to
      • ensure that the product is safe for market or not,
      • all the QC test reports are attached with batch record
      • all the calculation related to that batch are correct, and
      • several other parameters are checked and after ensuring the product safety then the QA person allow to distribute the product in the market.
  • Stability testing and evaluation of shelf-life of products: –

    • QA department is responsible for the stability testing of the pharmaceutical product manufactured in there factory. And ensure that the shelf life of the product is same as per the study and mention on the product to avoid the market complains.
  • Ensuring proper warehousing of finished products: –

    • Storage condition plays an important role in the stability of the Pharmaceutical products so the QA person ensures
      • all the parameters which are required to prevent the product decontamination during the storage.
  • Complaints and product recalls.:-

    • In case of any market complain come to the manufacturing Factory then it’s a responsibility of a QA department to act on that and the appropriate action is taken,
      • or in case product recall is required from the market then the QA department initiate the recall process and ensure all the products related to the complain batch is recalled.
      • All this decision is performed through the SOP.
  • Handling of Change Control Systems: –

    • Any other than validated step/ activity required to fix in any document and process is taken through the change control system
      • it’s a documented process to apply change in the Pharmaceutical industries. Change control system finally review by the QA department for approval.
  • Out of specification investigations:-

    • In any case during the testing of any pharmaceutical product the outcome is not per the expected outcome
      • and the final result come is different from the standard specification then the QA department come in role and perform an investigation to find the root cause through the specific SOP.
  • Event Investigation:-

    • In case of any unexpected event happened during the
      • manufacturing ,
      • testing ,
      • documentation of a pharmaceutical product

then the QA department is responsible for the investigation of the event ,find the root cause and take                              appropriate action to prevent such kind of events in future.

  • Returned products (salvage and disposal) :-

    • When the product is returned in the manufacturing factory due to any reason then the QA department is responsible to take action on the product
      • weather QA perform same addition process on the product to prevent or in case the product is not salvage the product is destroyed on the order of the QA department.
  • Internal Quality Audits and Quality Review: –

    • The Quality review and Internal audit and  comes in the major responsibilities of the QA department;
    • Internal Audit is performed by QA department frequently (surprisingly or scheduled)
    • To ensure that all other department in the Company is performing their activities As per SOP.
    • Quality Review is organized by the QA department to enhance the quality of the output of the company in all aspects like
      • product quality,
      • employee facility,
      • infrastructure,
      • machinery ,
      • company policies etc
  • Reprocessing of non-conforming products: –

    • QA department allow reprocessing the product in case the manufactured product don’ts meet the expected quality parameter in the final quality testing and the
    • QA department monitors all the reprocessing activities closely  .

Other Quality Assurance functions :

  • To achieve the objectives of Quality Assurance, below functions of the department has been classified but are not limited to this.
    • Plan and manage all the activities of Quality Assurance Dept. to assure the quality of all products manufactured by the Company.
    • Co-ordinate with manufacturing department in controlling their process and products at every stage of manufacturing to meet the established specifications through testing, auditing and reporting.
    • Review the adequacy and relevance of specifications & analytical procedures in co-ordination with Quality Control Dept. and R & D.
    • Co-ordinate technical audits of the Quality Control Laboratory to determine the analytical Quality Systems are yielding the highest quality information and to ensure that the analytical instrumentation is functioning properly and calibration and servicing is as per schedule.
    • Monitor the production environment and services to the production operation.
    • Products are stored, handled and distributed in a way to maintained product quality throughout their shelf life.
    • Maintenance of Quality Control records of manufacturing procedures for each batch manufactured.
    • Maintenance Records of
      • Release,
      • Quarantine or rejection of components and finished products,
      • Containers, closures and labels based on Quality Control test results.
    • Routine “Good Manufacturing Practices Auditing” of manufacturing process, control and related areas.
  • Suggest and organize training programmers’ for development of technical and administration skills of all the employees to meet with cGMP regulations on continuous basis, co-coordinating with Plant and Quality Head.
  • Establish guidelines and procedures on cGMP and Standard Operating Procedures of overall Quality Assurance activities. To review protocols related to
    • Method
    • Process
    • Cleaning
    • Analytical Method Validation etc.
  • Overall reviews of
    • non-conformance,
    • failure investigations,
    • analyzing the Quality trends,
    • investigations of market complaints,
    • batch failure investigations,
    • deviations,
    • verification of change control procedures,
    • updating the specifications,
    • test procedures,
    • manufacturing processes etc.
  • The Quality Assurance system is regularly audited by self inspection for effectiveness and applicability.
  • To follow reporting system to the Corporate Quality Head on weekly / monthly basis as per the standard procedure.


Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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