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Out of Specification (OOS)
Dr. Chinmaya Mahapatra
Learning Objectives
At the end of the lecture, students should be able to:
1.Define Out of Specification (OOS) results.
2.Differentiate OOS, OOT and laboratory error.
3.Explain the major causes of OOS results.
4.Describe the OOS investigation process.
5.Explain Phase I and Phase II investigations.
6.Understand the role of QA/QC in OOS investigation.
7.Apply root cause analysis and CAPA.
8.Explain appropriate handling of OOS results during batch disposition.
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
Out of Specification (OOS) Results in Pharmaceutical Quality Control