cGMP
Current
Good Manufacturing Practices
Good Manufacturing Practices
What for us all are here?
To
Make Medicines.
Make Medicines.
What are Medicines?
Medicines
are those which cures a patient without give any adverse reaction.
are those which cures a patient without give any adverse reaction.
A
medicinal product is fit for its purpose only when …………
medicinal product is fit for its purpose only when …………
=> It is the right product ,It
is the right strength ,It is free from
contamination
is the right strength ,It is free from
contamination
=> It has no way decorated
‘GONE OFF’ .It is the right container .It is correctly labeled .It is properly
sealed in the container and protected against damage and Contamination.
‘GONE OFF’ .It is the right container .It is correctly labeled .It is properly
sealed in the container and protected against damage and Contamination.
QUALITY:
‘QUALITY’ IS ONE OF THOSE WORDS THAT MEAN A
LOT OF DIFFERENT THINGS.
LOT OF DIFFERENT THINGS.
SOME
TIMES THE WORD IS USED TO MEAN ‘EXCELLENCE’ ‘GOODNESS’ ON THE OTHER HAND, SOME
PEOPLE SAY THAT A THING IS THE RIGHT WHEN IT MEETS OR COMPLIES WITH
SPECIFICATION.
TIMES THE WORD IS USED TO MEAN ‘EXCELLENCE’ ‘GOODNESS’ ON THE OTHER HAND, SOME
PEOPLE SAY THAT A THING IS THE RIGHT WHEN IT MEETS OR COMPLIES WITH
SPECIFICATION.
THEREFORE
QUALITY IS THE KEY ELEMENT OF MEDICINES
QUALITY IS THE KEY ELEMENT OF MEDICINES
Quality
shall build into the product using GMP, which Assures Quality
shall build into the product using GMP, which Assures Quality
Total Quality Assurance:
1.Consistent
and safe,2.Product Quality by manufacturing. Defect/Error free Operations 3.Consistent Quality of service to
Customers. 4.Product defect
prevention and continued improvement of technical Operations.5.For Shop floor, Upgrading skill
levels is the prime consideration as . 6.Development tool for individuals.7.Looking at problem from the
perspective of Customers
and safe,2.Product Quality by manufacturing. Defect/Error free Operations 3.Consistent Quality of service to
Customers. 4.Product defect
prevention and continued improvement of technical Operations.5.For Shop floor, Upgrading skill
levels is the prime consideration as . 6.Development tool for individuals.7.Looking at problem from the
perspective of Customers
“A
set of practices followed in every manufacturing related operation to obtain
the product
set of practices followed in every manufacturing related operation to obtain
the product
Of predefined specifications with as close to
zero defect as possible”
zero defect as possible”
“GMP
is continuously upgrading hence cGMP”
is continuously upgrading hence cGMP”
Objective
of GMP
1.Avoid mix up and cross contamination,2.Produce
drugs/medicines of reproducible quality to predefined specification (Validated
Process)
drugs/medicines of reproducible quality to predefined specification (Validated
Process)
In Other words GMP is …….
GOOD SCIENCE, COMMON SENSE, A DYNAMIC QUALITY
MANAGEMENT SYSTEM, PHILOSPHY WHAT REGULATORY AUTHORITIES HOPES IS THE BASIS FOR
CONTROL OF OUR PRODUCTS
MANAGEMENT SYSTEM, PHILOSPHY WHAT REGULATORY AUTHORITIES HOPES IS THE BASIS FOR
CONTROL OF OUR PRODUCTS
BASIC RULES OF GMP
1. Be sure you have the
correct written Instructions before start of any job.
correct written Instructions before start of any job.
2.
Always follow those instructions EXACTLY with no ‘cutting corners’. Ask if
don’t understand, if you can’t ask don’t do.3.Ensure that correct material
being used.4.Ensure that correct cleaned equipment being used.5.Prevent
Contaminations and Mix Up.6.Always guard against labeling error.7.Always work
accurately and precisely 8.Keep things (including yourself) clean and tidy.
Always follow those instructions EXACTLY with no ‘cutting corners’. Ask if
don’t understand, if you can’t ask don’t do.3.Ensure that correct material
being used.4.Ensure that correct cleaned equipment being used.5.Prevent
Contaminations and Mix Up.6.Always guard against labeling error.7.Always work
accurately and precisely 8.Keep things (including yourself) clean and tidy.
9.Always
report mistake error and bad practices immediately (Covering up could cost
lives).10.Make clear, accurate records of what has been done and checks carried
out.
report mistake error and bad practices immediately (Covering up could cost
lives).10.Make clear, accurate records of what has been done and checks carried
out.
PERSONAL HYGIENE AND ITS IMPORTANCE IN
THE GM
Personal
Cleanliness is key for Cleanliness at work and ultimately this leads to
achieving one aspect of GMP.
Cleanliness is key for Cleanliness at work and ultimately this leads to
achieving one aspect of GMP.
Word
‘Hygiene’ is of Greek origin. Hygiene is covered with the prophylactic
(preventive) maintenance of health and hence with prevention of disease.
READ MORE ChemistryNotesInfo.com: Chemistry Notes for 9th, 10th, 11th, 12th, BSc, MSc and Spectroscopy: cGMP - Current Good Manufacturing Practices: cGMP Current Good Manufacturing Practices What for us all are here? To Make Medicines. What are Medicines? Medicines...‘Hygiene’ is of Greek origin. Hygiene is covered with the prophylactic
(preventive) maintenance of health and hence with prevention of disease.
Posts
