Remix education
pharmacy study material

Quality Assurance (Unit:- 1)

Quality Assurance and Quality Management concepts: Definition and
concept of Quality control, Quality assurance and GMP
Total Quality Management (TQM): Definition, elements, philosophies
ICH Guidelines: purpose, participants, process of harmonization, Brief
overview of QSEM, with special emphasis on Q-series guidelines, ICH stability
testing guidelines
Quality by design (QbD): Definition, overview, elements of QbD program,
tools
ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration
NABL accreditation : Principles and procedures

QUALITY ASSURANCE AND QUALITY MANAGEMENT CONCEPTS
DEFINITIONS:
 Quality Assurance (QA) is a way of preventing mistakes and defects in
manufactured products and avoiding problems when delivered products or
services to customers,
 ISO 9000 defines as “part of quality management focused on providing
confidence that quality requirements will be fulfilled” In the ensuring discussions numerous activities aimed at maintaining the production of quality are dealt with. In principle, three levels of organization of these activities can be distinguished. From the top down these levels are:
1. Quality Management (QM)
2. Quality Assurance (QA)
3. Quality Control (QC)
QUALITY ASSURANCE QUALITY CONTROL
 QA include process checklists
and project audits as well
 To ensure that standards and procedures are followed to and that delivered product or service meet performance requirements
 QC activities includes
deliverable peer reviews and the
testing process too
 Monitoring the quality of
finished product through measures and an overall corporate commitment to
producing defect-free products
Good Manufacturing Practice (GMP)
o Good Manufacturing Practice (GMP) is a system for ensuring that manufacturers
produce goods consistently and in a control of manufacturing in accordance with pre-determined quality standards.
o Companies and organization must produce their goods according to quality
standards. GMP consists of basic preventive guidelines for factory and facility operations.
CONCEPTS OF QUALITY CONTROL, QUALITY ASSURANCE AND GMP
QUALITY:
Quality’s most simple definition is “fitness for use” If the user of the product is happy when using the product then the product may be called as a quality product.

QUALITY RELATIONSHIP:
Quality management aspects (policy)
Quality system (organizational structure) Quality assurance (confidence to the management) Good Manufacturing Practise Quality control (operational technique and activities)
QUALITY CONTROL:
A major part of the quality assurance is the Quality Control defined by ISO as “the operational techniques and activities that are used to satisfy quality requirements.” An important part of the quality control is the Quality Assessment: The system of activities to verify if the quality control activities are effective, in other words, an evaluation of the products themselves. Quality control is primarily aimed at the prevention of errors. Yet, despite all efforts, it remains inevitable that errors are made. Therefore, the control system should have checks to detect them. When errors or mistakes are suspected or discovered it is essential that the “Five W’s” are trailed:
 What error was made?
 Where was it made?
 When was it made?
 Who made it?
 Why was it made?
Only when all these questions are answered, proper action can be taken to correct the error and prevent the same mistake being repeated.
Performs following activities:
Routine:
 RM & PM analysis
 Intermediate stage analysis
 Finished products analysis
 Stability studies
Non-Routine:
 Calibration & Preventive maintenance of instruments
 Preparation of reference/working standards
 Methods development/validation
Activities managed through:
 Instrumental analysis
 Chemical analysis (RM & FG)
 Microbiological Analysis
 Packing Material Analysis

The techniques and activities involved in Quality Control can be divided into four levels of operation:
 First-line control: Instrument performance check.
 Second-line control: Check of calibration or standardization.
 Third-line control: Batch control (control sample, identity check).
 Fourth-line control: Overall check (external checks: reference samples, inter- laboratory exchange programmes).
QUALITY ASSURANCE AND GMP
QUALITY ASSURANCE Proper Quality Management implies consequent implementation of the next level:
Quality Assurance. The ISO definition reads: “The assembly of all planned and
systematic actions necessary to provide adequate confidence that a product, process, or service will satisfy given quality requirements.” The result of these actions aimed at the production of quality, should ideally be checked by someone independent of the work, the Quality Assurance Officer. If no QA officer is available, then usually the Head of Laboratory performs this job as part of his quality management task. In case of special projects, customers may require special quality assurance measures or a quality plan.
Good Manufacturing Practices (GMPs)
GMPs (Good Manufacturing Practices) is part of a quality system covering the
manufacture and testing of pharmaceutical dosage forms or drugs and active pharmaceutical ingredients,
Quality Assurance diagnostics, foods, pharmaceutical products, and medical devices.
GMPs are guidance that outlines the aspects of production and testing that can impact the quality of a product.
Quality Assurance/GMP Objectives
Quality Assurance is a wide-ranging concept, which covers all matters, which
individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use.
QualityAssurancethereforeincorporatesGoodManufacturingPractices. The system of quality assurance appropriate to the manufacture of pharmaceutical products to ensure
that:
1. 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) and good clinical practice(GCP)
2. Production and control operations are clearly specified in a written form and GMP requirements are adopted
3. Managerial responsibilities are clearly specified in job descriptions
4. Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials
5. All necessary controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out

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