These is and presentation of and Quality Assurance containing from and subject of and Quality planning and analysis

1. QUALITY ASSURANCE & CONCEPTS
SEMINAR
FOR
QUALITY PLANNING AND ANALYSIS
SEMESTER-II
PRESENTEDBY
MR. DEEPAK PATIL
GUIDEDBY:
MR. SHRIKANT MORKAR
DEPARTMENT
QUALITYASSURANCE TECHNIQUES
AISSMS COLLEGE OF PHARMACY,PUNE-01

2. DEFINATION
OF
QUALITY
ASSURANCE
CONCEPTS
OF
QUALITY
ASSURANCE
REFERENCES

4. DEFINATION :-
“Quality Assurance is a wide ranging concept covering all matters that
individually or collectively influence the quality of the product.”

5.  It is the activity of providing evidence to establish
confidence that quality requirements will be met.

6.  “Quality Assurance is sometime the name of department
concerned with many quality management activity such as
quality planning, quality control, quality improvement, quality
audit and reliability.”

7. Quality Assurance measures apply to the laboratory analytical
work overall, which includes;
 Identifying the person having the overall responsibility for
quality.
 Having laboratory equipment calibrated to recognised
standards.
 Using reference materials.
 Joining proficiency testing schemes with other
laboratories doing similar tests.

9.  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).
 Product and control operations are clearly specified in a
written form and GMP requirements are adopted.

10. Managerial responsibilities are clearly specified in job description.
Arrangements are made for the manufacture, supply and use of
the correct starting and packaging materials.
All necessary controls on starting materials, intermediate products,
and bulk products and other in-process controls, calibrations, and
validations are carried out.

11.  Deviation are reported, investigated and recorded.
 There is a system for approving changes that may have an impact
on product quality.
 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.

14. 1. Juran J.M., Godfrey A.B., “Juran’s Quality Planning and analysis
for Enterprise Quality”, Mc Graw Hills Publication, New Delhi,
Fifth Edition, 2007; Pg. No. 519-534.
2. Manohar A. Potdar , Pharmaceutical facility design and layout,
Nirali prakashan , pune page no.5.5 – 5.9 .