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 info@compliance-insight.com Free consultation over the phone

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