Functions of Quality Assurance : Pharmaceutical Guidelines

Functions of Quality Assurance

Quality assurance is an important part of pharmaceutical manufacturing. It assures the quality of the products those are manufactured in manufacturing facility. It is thought that documentation is the main function of quality assurance but it also controls the manufacturing system to manufacture the quality products.
1.0 Quality Assurance Department assures the quality of all the batches manufactured, at every stage of manufacturing/ processing of drug products.
2.0 This is achieved by performing the functions of monitoring as per the laid down QA systems for the following areas:
  • Warehousing of incoming components, containers and closures, labels etc.
  • Manufacturing process and process checks
  • Process monitoring and Process controls
  • Production Record Review
  • Final release or rejection of every batch of Drug Products for distribution and sale
  • Stability testing and evaluation of shelf-life of products
  • Warehousing of finished products (Drug Products)
  • Complaints and product recalls
  • Handling of Change Control Systems
  • Out of specification investigations
  • Investigation of deviations
  • Returned products (salvage and disposal)
  • Internal Quality Audits and Quality Review
  • Control of non-conforming products
  • Reprocessing of non-conforming products
3.0 To achieve the objectives of Quality Assurance, the functions of the department can be classified as follows:
  • To plan and manage all the activities of the Quality Assurance to assure the quality of all products manufactured by the Company.
  • To coordinate with the manufacturing department in controlling their process and products at every stage of manufacturing to meet the established specifications through testing, auditing and reporting.
  • To co-ordinate for development of specifications, the analytical procedure in coordination with the Quality Control and R&D.
  • To review the adequacy and relevance of specifications & analytical procedures in coordination with the Quality Control and R&D.
  • To 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.
  • To be responsible for the Quality Assurance and records and release functions of the QA Department which shall include:
  1. Maintenance of Quality Control records of manufacturing procedures for each batch manufactured.
  2. Records of release, quarantine or rejection of components and finished products, containers, closures and labels based on Quality Control test results.
  3. Routine “Good Manufacturing Practices Auditing” of the manufacturing process, control and related areas.

4.0 To suggest and organize training programmes for the development of technical and administrative skills of all the employees to meet with cGMP regulations on a continuous basis, which co-coordinating with Plant and Quality Head.
5.0 To establish guidelines and procedures on cGMP and Good Laboratory Practice – Standard Operating Procedures of overall Quality Control & Assurance Activities. Protocols related to Method / Process/ Cleaning/ Analytical Method Validation etc.
6.0 To assist Change Control Committee/Technical Committee for overall reviews of non-conformances, failure investigations, analyzing the Quality trends, investigations of market complaints, batch failure investigations, deviations, verifications of change control procedures, updating the specifications, test procedures, manufacturing processes etc.
7.0 To liaison with regulatory authorities for new products manufacturing licenses and renewals of the same and other regulatory requirements.
8.0 To follow the reporting system to the Corporate Quality Head on daily/ weekly/ monthly basis as per the standard procedure. (Reporting System)

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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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