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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
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
ID number on equipment
Written procedures on receipt, handling and sampling Stored off the floor Each container marked with lot number, name and status (released, quarantined, rejected)
Keep organized
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
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
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
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 info@compliance-insight.com Free consultation over the phone