Quality Assurance is a wide ranging concept which covers all matters which individually or collectively influence the quality of a product.It is the total sum of organized arrangements made with the object of ensuring that medical products are of the quality required for their intended use.
Quality Assurance is a wide ranging concept which covers all matters which individually or collectively influence the quality of a product.
It is the total sum of organized arrangements made with the object of ensuring that medical products are of the quality required for their intended use. Six Quality System concept is followed for cGMP Compliance.
1.Facility & Equipment System
4.Packaging & labeling System
5.Laboratory Control System
1.Facility & Equipment System
• Any building or buildings used in the manufacturing, processing, packing, or holding of a drug product should be of suitable size, construction and location to facilitate Cleaning, maintenance, and proper Operation.
• Equipment used in manufacturing, processing, packing, or holding of a drug product should be of appropriate design, adequate size, and
suitably located to facilitate operations for its intended use and for its cleaning and maintenance.
• Each container or group of containers for components or drug product containers, or closures is identified with a distinctive code for each
lot in each shipment received.
• This code is used to record the disposition of each lot.
• Each lot is appropriately identified as to its status i.e.
• Quarantined Approved Rejected3.Production System
• There are written procedures for production and process control designed to assure that the drug products have the identity, strength,
quality, and purity they purport or are represented to possess.4.Packaging & labeling System
• Labeling materials issued for a batch are carefully examined for identity & conformity of “Labeling Specified” in the Master or Batch
Production Record. 5.Laboratory Control System
• All equipment must have calibration / Maintenance plan.
• Proper documents are available and maintained.
• Provision for remedial action should be in place in the event of instrument breakdown.
• Quality system is part of Quality Assurance which ensures that products are consistently produced and controlled to the quality
standards appropriate to their intended use and as required by the Marketing Authorization or product specification.
Function of the Quality Assurance:]
• To ensure that all personnel have undergone training as per the requirements.
• Ensure the preparation, approval and implementation of SOP, Validation Protocol, Report, Stability Protocol, Report, BMR , BPR etc.
• Issuance, control, review and retrieval of all controlled Logbooks / Formats, Records, SOP, Specification, Worksheet, Protocol.
• To Ensure Compliance to Validation and Qualification Schedule.
• To Ensure effective implementation of Change Control Proposal System.
• Preparation and review of document like Validation Master Plan (VMP) and Site Master File (SMF).
• Ensuring effective implementation of Calibration and Preventive Maintenance Schedule.
• Environment monitoring and carrying out in-process checks during Manufacturing and Packaging process.
• Handling online rejection during Manufacturing and Packaging activity.
• Receiving and maintaining details related to Vendors.
• Approval or Rejection of all Drug Product Components, Drug Product container, closure, In-process material, Packaging material etc.
• Handling of Reserve Sample.
• Handling of Incidents / Planned Deviation / OOS (Out of Specification) with proper investigation & effective implementation of CAPA.
• Monitoring of Stability Studies.
• Review of Batch Manufacturing Record (BMR) / Batch Packaging Record (BPR) / Record of Analysis etc.
• Carryout periodic Self Inspection (Internal Quality Audit).
• Auditing the External Contract Laboratory.
• Preparation, review and approval of Annual Product Review (APR)
• Preparation of Management Review Report.