Basic cGMPs

A Basic Overview of the US FDA’s Regulations for Regulatory

Compliance

Basic cGMPs

• 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 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– don’t 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• Don’t 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

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