quality assuarance

1. Pharmaceutical industrial management
Quality assuarance.
By:- Drx Jayesh.M.Rajput
Quality assurance
1.Planned and systematic activities implemented within the quality system that can be
demonstrated to provide confidence that a product or service will fulfill requirements for quality.
2.quality assuarance is a system for evaluating performance,service of the quality of the product
against system standard or specified requirements for customers.
Quality assurance (QA) is a way of preventing mistakes and defects in manufactured products and avoiding problems when
delivering products or services to customers; which ISO 9000 defines as "part of quality management focused on providing
confidence that quality requirements will be fulfilled".[1]
This defect prevention in quality assurance differs subtly from defect
detection and rejection in quality control and has been referred to as a shift left since it focuses on quality earlier in the process
Current good manufacturing practices (cgmp)

2. Good manufacturing practices (GMP) are the practices required in order to conform to the
guidelines recommended by agencies that control the authorization and licensing of the
manufacture and sale of food and beverages,[1]
cosmetics,[2]
pharmaceutical products,[3]
dietary
supplements,[4]
and medical devices.[5]
These guidelines provide minimum requirements that a
manufacturer must meet to assure that their products are consistently high in quality, from batch
to batch, for their intended use. The rules that govern each industry may differ significantly;
however, the main purpose of GMP is always to prevent harm from occurring to the end user.[2]
Additional tenets include ensuring the end product is free from contamination, that it is
consistent in its manufacture, that its manufacture has been well documented, that personnel are
well trained, and the product has been checked for quality more than just at the end phase.[2]
GMP is typically ensured through the effective use of a quality management system (QMS).[1][2]
Good manufacturing practices, along with good agricultural practices, good laboratory practices
and good clinical practices, are overseen by regulatory agencies in the United Kingdom, United
States, Canada, Europe, China, India and other countries.
GLP(good laboratory practices)
In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality
system of management controls for research laboratories and organizations to ensure the
uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including
pharmaceuticals) non-clinical safety tests; from physio-chemical properties through acute to
chronic toxicity tests.[1]
GLP was first introduced in New Zealand and Denmark in 1972, and later in the US in 1978 in
response to the Industrial BioTest Labs scandal. It was followed a few years later by the
Organization for Economic Co-operation and Development (OECD) Principles of GLP in 1992;
the OECD has since helped promulgate GLP to many countries.
GLP applies to non-clinical studies conducted for the assessment of the safety or efficacy of
chemicals (including pharmaceuticals) to man, animals and the environment. [1] GLP, a data
quality system, is not the same as standards for laboratory safety - appropriate gloves, glasses
and clothing to handle lab materials safely. The principles of GLP aim to ensure and promote
safety, consistency, high quality, and reliability of chemicals in the process of non-clinical and
laboratory testing. GLP is not limited to chemicals and also applies to medical devices, food
additives, food packaging, colour additives and other non-pharmaceutical products or
ingredients.
TQM(total quality management)
Total quality management (TQM) consists of organization-wide efforts to "install and make
permanent climate where employees continuously improve their ability to provide on demand
products and services that customers will find of particular value."[1]
"Total" emphasizes that
departments in addition to production (for example sales and marketing, accounting and finance,
engineering and design) are obligated to improve their operations; "management" emphasizes
that executives are obligated to actively manage quality through funding, training, staffing, and
goal setting. While there is no widely agreed-upon approach, TQM efforts typically draw heavily
on the previously developed tools and techniques of quality control. TQM enjoyed widespread
attention during the late 1980s and early 1990s before being overshadowed by ISO 9000, Lean

3. manufacturing, and Six Sigma. There is no widespread agreement as to what TQM is and what
actions it requires of organizations,[10][11][12]
however a review of the original United States Navy
effort gives a rough understanding of what is involved in TQM.
The key concepts in the TQM effort undertaken by the Navy in the 1980s include:[13]
 "Quality is defined by customers' requirements."
 "Top management has direct responsibility for quality improvement."
 "Increased quality comes from systematic analysis and improvement of work processes."
 "Quality improvement is a continuous effort and conducted throughout the organization."
Quality documentation.
Validation of process.
Process validation and drug quality
1.effective process validation contributes significantly to assuaring drug quality

4. 2.quality ,safety and efficacy are designed or built into the product
3. quality cannot be adequately assured merely by in process and finished product
inspecting or testing
Process validation new paradigm FDA guidance
Process validation is now defined as the collection and evaluation of data from the
process design stage through commercial production which establishes scientific
evidence that a process is capable of consistently delivering quality product. Process
validation involves a series of activities taking place over the lifecycle of the product and
process.
Process validation new paradigm EMEA
1. validation is the act of demonstrating and documenting that a procedure operates
effectively.
2. process validation is the means of ensuring and providing documentary evidence that
process are capable of consistently producing a finished product of the required quality.
3. the documented evidence that the process operated within established
parameters can perform effectively and reproducibly to produce a medicinal
product meeting its predetermined specifications and quality attributes.
Validation of equipments

5. Parts of validation/qualification
1.preliminaries including design qualification (DQ)
2. installation qualification (IQ)
3. operational qualification (OQ)
4. performance qualification (PQ)
Maintenance change control requalification.
PRINCIPLE
Equipment must be Designed,constructed ,adapted ,maintained to perform the
operations which are to be carried out.

6. Validation of analytical procedure

8. Validation of an analytical procedure is the process by which it is established, by laboratory studies, that
the performance characteristics of the procedure meet the requirements for the intended analytical
applications.[1]
Method validation provides an assurance of reliability during normal use, and is
sometime referred to as “the process for providing documented evidence that the method does what it
is intended to do.” The main objective of the validation is to demonstrate that the analytical method is
suitable for its intended purpose, is accurate, specific and precise over the specified range that an
analyte will be analyzed. Analytical Method Validation is to be performed for new analysis methods or
for current methods when any changes are made to the procedure, composition of the drug product
and synthesis of the drugs substances.
Common types of analytical procedure that can be validated [2]
 Identification tests;
 Quantitative tests for impurities content;
 Limit tests for the control of impurities;
Quantitative tests of the active moiety in samples of drug substance or drug product or other selected
component(s) in the drug product.
Typical validation characteristics which should be considered are listed below: [3]
 Accuracy
 Precision
 Specificity
 Detection Limit
 Quantitation Limit
 Linearity
 Range
 Robustness
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