Functions of Quality Assurance, Purpose:
Functions of Quality Assurance, The purpose of this SOP ( Standard Operating Procedure) is to outline the functions, principle duties and responsibilities of personnel working in Quality Assurance Department.
Functions of Quality Assurance, Scope:
To provide the guidelines for the proper implementation of the Quality Assurance System at XX Pharmaceuticals Limited ( Both General and Cephalosporin Block).
Definitions / Abbreviation:
[][]Quality Control Department : The Department carrying out day to day activities for the control of procedure, tests & analysis of products/ raw materials/ packaging materials/ stability samples and other relevant analysis of samples at laboratory to assist the manufacturing functions.
[][]Quality Assurance Department: The department carrying out day to day activities for the control of procedure, analysis of documents, regulatory functions, to assist the plant functions for the manufacturing, distributions and other relevant functions.
[][]CAPA : Corrective Action and Preventive Action.
Responsibilities:
[][]The roles and responsibility is as follows:
Executive, Quality Assurance
[][]To follow the guidelines of Quality Assurance
[][]To report their findings to their seniors
Asst. Manager, Quality Assurance
[][]To ensure implementation of the SOP.
AGM, Quality Assurance
[][]Approval of the SOP.
Procedure:
[][]Quality Assurance Department shall function for assuring the quality of all the manufactured batches and every stage of manufacturing / processing of drug Products.
[][]This shall be achieved by performing the functions of monitoring as per the laid down QA systems for the following areas:
[][]Monitor of incoming starting and packaging materials.
[][]Manufacturing process and process checks.
[][]Process monitoring and process control.
[][]Production Record Review.
[][]Final release or rejection of every batch of Drug Products for distribution and sale.
[][]Monitor stability testing and evaluation of shelf-life of products.
[][]Complaints handling and product recalls.
[][]Handling of Change Control Systems.
[][]Out of specification investigation.
[][]Investigation of Deviations.
[][]Returned products ( salvage and disposal ).
[][]Internal Quality Audits.
[][]Co-ordinate monthly Quality Review Meeting and implement the effective CAPAs regarding quality improvement.
[][]Control of non-confirming products.
[][]Co-ordinate all validation and qualification activities.
[][]Reprocessing of non-confirming products.
[][]To achieve the objectives of Quality Assurance functions of XX Pharmaceuticals Limited is classified as follows :
[][]To plan and manage all the activities of Quality Assurance Department to assure the quality of all products manufactured by the Company.
[][]To co-ordinate with manufacturing department in controlling their process and products at every stage of manufacturing to meet the established specifications though testing, auditing and reporting.
[][]To co-ordinate for the development of new product formulation, development of specifications, analytical procedure in co-ordination with Quality Control Department and Product Development Department.
[][]To review the adequacy and relevance of specifications & analytical procedures in co-ordination with Quality Control Department and Product Development Department.
[][]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 release functions of the QA Department which shall include :
[][]Maintenance of Quality Control records of manufacturing procedures for each manufactured batch.
[][]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.
[][]To suggest and organize training program for the development of technical and administration skills of all the employees to meet with cGMP regulations on continuous basis, coordinating with GM, Plant and Quality Head.
[][]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.
[][]To liaison with regulatory authorities for new products manufacturing license and renewals of the same and other regulatory requirement.
Annexure:
N/A