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Basic CGMPS: A Basic Overview of The Us Fda'S Regulations For Regulatory Compliance Compliance Insight, Inc

The document provides an overview of the US FDA's current Good Manufacturing Practices (cGMP) regulations for regulatory compliance. It summarizes key aspects of the regulations including organization and personnel requirements, building and facility standards, equipment maintenance, control of raw materials, production and process controls, documentation standards, and laboratory testing procedures. The goal of the cGMP regulations is to ensure quality control and consumer safety in pharmaceutical manufacturing.

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62 views

Basic CGMPS: A Basic Overview of The Us Fda'S Regulations For Regulatory Compliance Compliance Insight, Inc

The document provides an overview of the US FDA's current Good Manufacturing Practices (cGMP) regulations for regulatory compliance. It summarizes key aspects of the regulations including organization and personnel requirements, building and facility standards, equipment maintenance, control of raw materials, production and process controls, documentation standards, and laboratory testing procedures. The goal of the cGMP regulations is to ensure quality control and consumer safety in pharmaceutical manufacturing.

Uploaded by

Sandy Piccolo
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
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Basic cGMPs

A Basic Overview of the US FDAs


Regulations for Regulatory Compliance
Compliance Insight, Inc.

Basic cGMPs
Remember, QUALITY
is the responsibility of
everyone
Dont just make the
product or do your job
and leave it up to
Quality Assurance fix
the problems

The Regulations
cGMP stands for current
Good Manufacturing
Practices
Always improving and
changing (that is why they
are called current)
Regulations are a
minimum that must be met

The Regulations
cGMPs are listed in the
CFR (Code of Federal
Regulations) Part 210
and 211
Part 210 - definitions
Part 211 - basic
instructions
Part 11 - electronic
data

Organization and Personnel


Shall have a Quality Unit
with responsibility to reject
or approve all material,
procedures and
specifications
Everyone will have
sufficient training,
knowledge and experience
to do their job

Organization and Personnel


Wear clean clothing
Wear protective apparel to
prevent contamination
Practice good sanitation
If you are sick or have open
lesions that would impact the
drug, then you will be
excluded from direct contact
with the product

Buildings and Facilities


Building will be
adequately sized for
proper storage of
equipment and
material
Operations will be
performed in specific
areas

Buildings and Facilities


Raw materials received will be
placed in quarantine until tested
Rejected material will be
separated
There will be adequate lighting
There will be adequate
environmental controls
There will be air breaks on drains

Buildings and Facilities


Sewage and trash will be
stored and disposed of in
a safe and sanitary
manner
Adequate washing and
toilet facilities will be
available
hot and cold water
soap
single service towels

Buildings and Facilities


Building will be
maintained in a clean
and sanitary manner
There will be cleaning
schedules with approved
cleaning agents
SOPs on cleaning

Buildings in a good state


of repair

Buildings and Facilities


Buildings maintained
pest and rodent free
Written procedures
and approved
rodentcides,
insecticides and
fungicides
will not affect product

Equipment
Will be maintained in a good
state of repair
written schedule of maintenance

will be cleaned
written schedule of cleaning
clean after each batch

approved cleaning agents


will not affect product

ID number on equipment

Control of Raw Materials


Received in Quarantine
not used until released

Written procedures on receipt,


handling and sampling
Stored off the floor
Each container marked with lot
number, name and status
(released, quarantined, rejected)

Control of Raw Materials


Sampling

shall be representative
maintain cleanliness
in approved area
prevent cross contamination
containers marked showing
samples taken

Production and Process Control


There will be written procedures
Document activities
batch record
log books

Control contamination
Cleanliness
tanks, paddles, piping, probes, etc.

Keep organized

Production and Process Control


Reconciliation to be
done
Make sure areas are
cleared of other lot
information
(packaging, labeling,
etc.) prior to working
with another lot
Double checks

Warehouse
It shall be clean
Sections clearly identified
(quarantine, released, rejected)
quarantine - yellow
released - green
rejected - red

First In - First Out


Track inventory and sold lots
(quantities to where)

Laboratory
Will have specifications, standards,
sampling plans, test procedures
Shall have a calibration and
maintenance program
written with a time period for
performance

Document all testing


use logbooks

Laboratory
Tell supervisor if something goes wrong
dont continue with testing if done
improperly
check results prior to discarding sample
have second person check
check acceptance values

Stability testing will be done


Reserve samples will be kept for final
products over the period of the expiration
date

Documentation
Records will be maintained

batch records
testing
investigations
training
maintenance
cleaning
almost everything

If it was not documented, then it did not


happen!
Written in ink

Documentation
Cross out with single line; initial
and date
No white-out
Dont use scrap paper
Change control on all documents
if changes are made, they have to be
reviewed

Sign only what you performed or


verified

Documentation
Write down correct date
do not write down previous date (back
dating)
If you forgot to sign something on a
previous date, correct the problem by
writing:
Performed on May 10, 2012; written on
May 12, 2012

Questions?
Contact us at:

www.Compliance-Insight.com
513-860-3512
[email protected]
Free consultation over the phone

Copyrighted 2013 by Compliance Insight, Inc. 513-860-3512

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