Quality Assurance

Table of Contents

What is the Role of Quality Assurance department in Pharmaceutical Industry…???


ICH:-ICH Good Clinical Practice Definition of Quality Assurance. The planned and systematic actions that are established to ensure that the trial is. performed and the data are generated, documented, and recorded in compliance with Good Clinical Practice and applicable regulatory requirements.ISO:-Quality Assurance. The ISO 9000 definition states that quality assurance is part of quality management focused on providing confidence that quality requirements will be fulfilled. Both customers and managers have a need for quality assurance as they cannot oversee operations for themselves.WHO:-
Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. With regard to pharmaceuticals, quality assurance can be divided into major areas: development, quality control, production, distribution, and inspections.USFDA:-Proactive and retrospective activities that provide confidence that requirements are fulfilled.

Quality Assurance

1.1 Principle. “Quality assurance” is a wide-ranging concept covering all
matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. Quality assurance, therefore, incorporates GMP and other factors, including those outside the scope of this guide such as product design and development.
1.2 The system of quality assurance appropriate to the manufacture of pharmaceutical products should ensure that:
(a) pharmaceutical products are designed and developed in a way that takes
account of the requirements of GMP and other associated codes such as those of good laboratory practice (GLP)1 and good clinical practice (GCP);
(b) production and control operations are clearly specified in a written form and GMP requirements are adopted;
(c) managerial responsibilities are clearly specified in job descriptions;
(d) arrangements are made for the manufacture, supply, and use of the correct starting and packaging materials;
(e) all necessary controls on starting materials, intermediate products, and
bulk products and other in-process controls, calibrations, and validations
are carried out;
(f) the finished product is correctly processed and checked, according to the
defined procedures;
(g) pharmaceutical products are not sold or supplied before the authorized persons have certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control, and release of pharmaceutical products;
(h) satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored by the manufacturer, distributor, and subsequently handled so that quality is maintained throughout their shelf-life;(i) there is a procedure for self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the quality assurance system;
(j) deviations are reported, investigated and recorded;
(k) there is a system for approving changes that may have an impact on product quality;
(l) regular evaluations of the quality of pharmaceutical products should be conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement.
1.3 The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the marketing authorization and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality the objective is the responsibility of senior management and requires the participation and commitment of staff in many different departments and at all levels within the company, the company’s suppliers, and the distributors. To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of quality assurance incorporating GMP and quality control. It should be fully documented and its effectiveness monitored. All parts of the quality assurance system should be adequately staffed with competent personnel and should have suitable and sufficient premises, equipment, and facilities.

SOPs comes Under Quality Assurance Department.

SOP For Change control
SOP For Handling of incidents and deviations
SOP For Training of employees
SOP For Self inspection
SOP For Risk management
SOP For Documentation control
SOP For Corrective Action & preventive action (CAPA)
SOP For Process validation
SOP For Cleaning validation
SOP For Evaluation & approval of contract testing laboratory
SOP For Failure investigation
SOP For Market complaint
SOP For Handling of Reprocessing, Reworking, and Recovery
SOP For Qualification stages of equipment / system / utilities
SOP For Out of specification (OOS)
SOP For Product recall
SOP For New product introduction
SOP For Process performance and product quality monitoring and management review
SOP For Line clearance
SOP For Handling of rejected materials
SOP For Handling of Artwork
SOP For Annual Product Quality Review
SOP For Vendor qualification
SOP For Review of batch manufacturing record
SOP For Document storage
SOP For Calibration
SOP For Mock recall
SOP For Water system qualification & validation
SOP For Preparation, review, and approval of Batch record (BMR/BPR)
SOP For Sampling of semi-finished & finished products
SOP For In-process checks
SOP For Sampling procedure of rinse and swab sample
SOP For Item code generation of raw and packing material
SOP For Product code generation
SOP For Batch numbering system
SOP For Assigning of manufacturing and expiry date for finished product
SOP For Operation, Cleaning & calibration of weighing balance
SOP For Preparation and review of site master file
SOP For Out of trend
SOP For Technology transfer
SOP For Operation and cleaning of sampling rod
SOP For Trend Analysis
SOP For Men and material movement
SOP For Power failure
SOP For Creation, Control, Revision, Access, and archival of electronic documents
SOP For Postmarketing surveillance of marketed products
SOP For Handling of data logger during distribution and transportation of finished goods
SOP For Dispatch of finished goods for EU market
SOP For Acceptance Quality Level
SOP For Operation of the data logger, monitoring of temperature and relative humidity and evaluation of recorded data
SOP For Handling of product yield
SOP For Validation and verification of the analytical method
SOP For Reconciliation of packing material
SOP For Allocation of Pharma Code
SOP For Glass Breakage Policy
SOP For Document Numbering System
SOP For Recording of Temperature, Relative Humidity, and Pressure differential

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