Functions and Reporting system of Quality Control Department in Pharmaceuticals.

In Pharmaceutical industries Quality Control (QC) is believe as one of the most vital department.It acts as a barrier between the manufacturing unit and Market to ensure the Quality of the manufactured product. In Quality Control Functions Large numbers of employees are work together in QC department at different grade with a common Aim, which is to ensure the Quality of the product during all stages of manufacturing / processing of Drug Products.

A quantitative analysis is an effort to conclude the actual drug concentration w.r.t  required drug concentration of a specific substance in the sample which collected during the manufacturing of the product.

Functions and Reporting System in Quality Control (QC):-

Quality Control Functions –

  • Quality Control Department functions for assuring the quality of all the batches manufactured, at every stage of manufacturing / processing of Drug Products.
  • The objective of QC Department is achieved by performing the following functions of QC in the following areas (but not limited to) :-
    • Co-ordination with :
      • Manufacturing department in controlling of their process and products at every stage of manufacturing to meet the pre-established specifications through testing, auditing and reporting
      • Quality Assurance Department and with R & D for development of specifications and analytical procedure.
      • Technical audits of the Quality Control Laboratory to determine the analytical Quality Systems for yielding the highest quality information
    • Plan and manage all the activities of Quality Control Department.
    • Review the adequacy and relevance of specifications & analytical procedures in co-ordination with Quality Assurance Department and R& D.
    • Ensure the functioning of analytical instruments and equipments.
    • Perform the calibration and preventive maintenance of instruments and equipments as per schedule.
    • Maintenance of Quality Control records, Control samples of raw materials and drug products of each batch manufactured.
    • Sampling, inspection and testing of
      • Raw material as per STP and approval or rejection after verifying the observations / results as per specifications and its documentation.
      • Packaging material as per STP and approval or rejection after verifying the observations / results as per specifications and its documentation.
      • Inspection and testing of in-process sample / semi-finished products as per STP and approval or rejection for further processing or reprocessing after verifying the observations / results as per specifications and its documentation.
      • Inspection and testing of final products as per STP and approval or rejection after verifying the observations / results as per specifications and its documentation.
      • Stability testing and evaluation of shelf-life of products.
    • Calibration, Qualification and Preventive maintenance of instruments and equipments.
    • Pre-shipment sample analysis for vendor approval.
    • Microbiological analysis of
      • raw materials
      • finished products
      • packing materials,
      • stability samples,
      • in process samples,
      • water samples and environmental bio-burden monitoring,
      • market complaints and
      • other miscellaneous samples
    • Analytical investigation for Events, Complaints and Product recalls.
      • Analytical support for evaluating the Change Control proposals & Systems.
      • To participate for Out of specification / Repeat analysis / Out of Trend / investigations and to analyze the samples required for investigation.
      • Investigation and documentation of system/analytical deviations.
      • To participate for Investigation of out of calibration of instruments/equipments and to calibrate the instruments/equipments and to analyze the samples required for closing of Out of calibration.
      • Analysis of Validation sample / Qualification samples.
      • Analysis of Returned products (salvage and disposal).
    • Internal Quality Audits and Quality Review.
      • Analysis for Control of non-conforming products.
      • To analyze the samples required for qualification of working standards.
      • Volumetric solution preparation and standardization,
      • General reagents preparations, Colorimetric solutions, Indicator Solution preparation.
      • Analysis of cleaning agent / swab samples / wash water samples and cleaning validation samples.
      • Implementation of Corporate Quality Assurance guidelines in Quality Control Laboratory.
      • Monitoring of Pharmacopoeial changes.
      • Performance and documentation of Analytical method validation and Analytical method transfer.
      • Innovator sample analysis, Comparison with RLD.
    • Back up and retrieval of electronic data.
      • Training to the employees as per training schedule.
      • Records of release, quarantine or rejection of raw material, finished products, containers, closures and labels on Quality control test results.
      • Routine ‘Good Laboratory Practices Auditing’ of control process, and related areas.
      • To suggest and organize the training programs for development of technical and administration skills of all the employees to meet with cGLP regulations on continuous basis, which shall be done by co-ordination with Plant Head and Quality Heads.
      • To establish guidelines
        • On cGMP and Good Laboratory Practices,
        • Standard Operating Procedures of overall Quality Control activities.
        • Prepare Protocols related to Method/ Process/Cleaning/Analytical Method Validation/Analytical method transfer etc.
      • Evaluate
        • the Change Control suggestions for overall review of non-conformance,
        • failure investigations,
        • analyzing the Quality trends,
        • investigations of market complaints,
        • batch failure investigations,
        • deviations,
        • verification’s of change control procedures,
        • updating the specifications, test procedures, manufacturing processes etc.
      • Follow reporting system as per SOP for Reporting System for quality department.
      • Prepare Protocols related to Method/ Process/Cleaning/Analytical Method Validation/Analytical method transfer etc.

More about Quality Control Functions click here

Reporting System in Quality Control Department (QC):-

The overall quality system monitoring and notification to management is defined in two phases through review of:-

  • Routine Quality Control related documents.
  • Daily/Monthly/Quarterly & Half Yearly Quality control report received from plant.

QC shall prepare Daily Report/Monthly report/Quarterly Report and forward to CQ and same shall be forwarded to CQ or Director, V.P. – Quality, V.P. – Operations, Plant Head on Daily /Quarterly / monthly basis  for  review which shall contain following details but not limited to.

    • Summary of

      • Analysis and productivity details.
      • Sample release.
      • Pending analysis due to external factor.
      • Repeat analysis.
      • Out of Specification (OOS)
      • Rejection (Raw Material /Packaging Materials /Finished Product).
      • Stability failure.
      • Stability missing station.
      • Event & investigations in QC.
      • Pharmacopoeial changes.
      • Corrective and Preventive Actions -CAPA (QC).
      • Analytical issues.
      • Training conducted in QC.
      • Instrument utilization.
      • Method validation & method transfer.
      • Process validation.
      • Sample calculation details.
      • Routine & Non Routine Samples.
      • Release Cycle Time.
      • Productivity Of Section Chemists.
      • Audit Reports.
      • Achievements And Setbacks.
      • Third Party Contract Manufacturing Matters.
      • Break down of Instruments / Equipments.
      • Other activities.
  • Daily Work Report :

    • Daily work report and status shall be submitted to the immediate superior and department head.
    • Any non conformance during analysis shall be immediately informed to immediate supervisor and department head.
    • Department head shall take further action as per reference SOP of Investigation of Out of Specification Analysis result and Repeat Analysis.
  • Review of six monthly statistical evaluation report for OOS respectively :

    • Plant QC shall prepare summary of statistical evaluation of OOS and shall forward to CQ for review.
    • CQ shall review the above quality documents and discuss with the concerned person and give the review comments to plant for implementation.
    • Quality head of site shall ensure the implementation of CQ observations.
    • In case of any constraints in implementing the CQ observations the plant Quality head shall discuss with Corporate Quality for further actions..

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