Introduction of Quality Assurance

Quality Assurance:

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
2.Material System
3.Production System
4.Packaging & labeling System
5.Laboratory Control System  
6.Quality 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.

2.Material System
 • 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 Rejected

3.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.

6.Quality System
• 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.