cGMP (current Good

Manufacturing Practices)
& GMP (Good
Manufacturing Practices)
What is cGMP and GMP?
GMP ..

- is a system for ensuring that products are

consistently produced and controlled
according to quality standards.
cGMP is …

- cGMP stands for “current Good

Manufacturing Practices” Always
improving and changing (that is why they
are called “current”)
What are the difference of
cGMP and GMP?
The Importance of cGMP and
GMP
GMP a system for ensuring that products
are consistently produced and controlled
according to quality standards

cGMPs provide for systems that assure

proper design, monitoring, and control of
manufacturing processes and facilities.
People

 Needto have a clear roles and

responsibilities
 Need to follow all procedures
 Be fully trained and assessed for the work
they do.
REGULATION

Shall have a Quality Unit with

responsibility to reject or approve all
material, procedures and specification
Wear clean clothing
Wear personal protective equipment
Practice good sanitation
Procedures

 Should be documented and recorded

 Cover all critical processes
 Ensure all non-conformities are
investigated and reported
REGULATION
Records will be maintained
 Job order
 Testing
 Investigation
 Training
 Maintenance
 Cleaning
If it was not documented, then it did not
happen!
Products

 Havespecifications for raw materials,

components, intermediate and finished
products

 Allproduct must undergo constant testing,

comparison, and quality assurance before
distributing to customer.
REGULATION
Received in Quarantine
 Not used until released
Written procedures on receipt, handling
and sampling
Stored off the floor
Each product/design marked with lot
number, name and status
(released,quarantine,rejected)
REGULATION
Sampling
 Maintain cleanliness
 Jumbo marked showing samples taken
Premises & Equipment

 Aredesigned to allow effective cleaning

and prevent cross-contamination

 Arevalidated and calibrated, have

procedures, schedules and records.
REGULATION
Building will be adequately sized for
proper storage of equipment and material
Operations will be performed in specific
areas
Raw materials received will be placed in
quarantine until tested
Rejected material will be separated
REGULATION
There will be adequate environmental
controls
Sewage and trash will be stored and
disposed of in a safe and sanitary manner
Adequate washing and toilet facilities
available
Building will be maintained in a clean
and sanitary manner
REGULATION
Buildings in a good state of repair
Building maintained pest and rodent free
Written procedures and approved
rodentcides
ID number of equipment
Process
 Are clearly defined, consistent and
documented

 Have critical steps and identified

 Strong and healthy change control procedures.

REGULATION
There will be written procedures
Document activities
 Logbooks
 Forms
Cleanliness
 Machine, mixing paddle, drums, etc.
Keep organized
REGULATION
Reconciliation to be done
Make sure areas are cleared of other lot
information (batch number, design, etc)
Double checks
Basic Concepts ..

 Remember, QUALITY is the

responsibility of everyone.

 Don’t just make the product or do your

job and leave it up to Quality Assurance
fix the problem.