What is 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.


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.

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.


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
(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, distributed, 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
(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
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

SOPs comes Under Quality Assurance Department.

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

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