GMP in Pharmaceutical Industry
Made by Kashish Wilson
Assistant Professor,
MM College of Pharmacy,MM(DU) Mullana Ambala
QUALITY
“Quality is never an accident.”
“It is always the result of high intention,
sincere efforts and intelligent direction and
skillful execution. It represents the choice
of many alternatives.”
What is cGMP ?
“cGMP” – where c = creating, Implementing,
and sustaining a culture of compliance of quality
in pharma industry
GMP-Is that part of Quality
Assurance aimed at ensuring
that products are consistently
manufactured to a quality
appropriate to their intended
use
QA-It is the sum total of the
organized arrangements with
the objective of ensuring that
products will be of the quality
required for their intended use
GMP
OBJECTIVES
To understand key concepts of quality
assurance, quality control and GMP.
To understand specific requirements of
GMP regulations.
To understand basic requirements of each
GMP element.
GOOD MANUFACTURING PRACTICES
Medicine : Special Commodity
Potent weapon for deceased human being
Hence potent weapon should be of the highest
• Strength
• Purity
• Quality
Understanding the definition of GMP
GMP is that part of
Quality Assurance
which ensures that product are consistently
manufactured and controlled
for the purpose of their intended use or
as required by the marketing authorization
Thank You

cGMP.ppt

  • 1.
    GMP in PharmaceuticalIndustry Made by Kashish Wilson Assistant Professor, MM College of Pharmacy,MM(DU) Mullana Ambala
  • 2.
    QUALITY “Quality is neveran accident.” “It is always the result of high intention, sincere efforts and intelligent direction and skillful execution. It represents the choice of many alternatives.”
  • 3.
    What is cGMP? “cGMP” – where c = creating, Implementing, and sustaining a culture of compliance of quality in pharma industry
  • 4.
    GMP-Is that partof Quality Assurance aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use
  • 5.
    QA-It is thesum total of the organized arrangements with the objective of ensuring that products will be of the quality required for their intended use
  • 6.
    GMP OBJECTIVES To understand keyconcepts of quality assurance, quality control and GMP. To understand specific requirements of GMP regulations. To understand basic requirements of each GMP element.
  • 7.
    GOOD MANUFACTURING PRACTICES Medicine: Special Commodity Potent weapon for deceased human being Hence potent weapon should be of the highest • Strength • Purity • Quality
  • 8.
    Understanding the definitionof GMP GMP is that part of Quality Assurance which ensures that product are consistently manufactured and controlled for the purpose of their intended use or as required by the marketing authorization
  • 9.