Principle #3 - Promptly and Accurately Documenting Work For Compliance and Traceability

A record is a document that recalls or relates past events. It is a body of known facts. The records your company keeps to comply with the GMP regulations concern the people, the equipment and the step-by-step processes of manufacturing a quality processes of manufacturing a quality product. These records provide a complete history of your product and provide a means of evaluating the source of any complaints regarding your products.

The records you keep on the job are like the records doctors keep in a hospital. Patient charts record current condition and medical history records are reviewed to ensure quality health care. These records relate the exact activities that were performed on the patient. Your records also relate the exact steps that were completed to manufacture the product.

Accurate Records Are Important

Although it may seem unnecessary to write down every step in the production process, keeping accurate records is really very important to your company. The GMP regulation requires the company to keep complete and accurate records about its products. Because the GMP regulation has the force of law, the Food and Drug Administration (FDA) has a right to examine these records when they inspect your plant. Poor and inadequate records are violations of the law and are often cited by FDA inspectors in their reports of plant inspections.

It also makes good business sense to keep accurate records. Accurate records tell us whether or not you are consistently manufacturing quality products. Just as a witness's testimony serves as proof of a series of events, our records show proof that we manufactured a product of the highest possible quality.

Finally, when you record each step of the manufacturing process promptly and accurately, and in accord with written procedures, you prevent mixups and errors.  Preventing mixups and errors is the best way to avoid costly recalls and protect the customers.

GMP Records We Must Keep

The GMP Regulations requires that records be kept for each step of the manufacturing process, from the time components enter the plant as raw materials until the finished product is distributed. The regulation also requires that we record the results of all laboratory tests necessary to assure that we comply with established specifications and standards.

Some required records include:

Written Procedures - Our Roadmap

Written procedures are the best guide to good record keeping. These procedures state exactly what records must be kept and how they must be maintained.

Written procedures also designate the persons responsible for preparing, dating, and signing the GMP records. For significant steps in the manufacturing process, a second person is designated to check and sign the work.

Guidelines for Good Record Keeping

You can make good record keeping part of your everyday GMP lifestyle provided you follow some basic guidelines:

1. Record all necessary information immediately upon completion of a task - don't trust your memory.
2. Where a signature is required, write your name legibly and in ink - no white out or erasures allowed. 
3. Report any deviation from written procedures to your supervisor. All deviations must be approved and documented.
4. Don't document someone else's work unless you are designated to do so.
5. Don't assume that undocumented work has been properly completed.

Summary

Before any product is released to the market, a complete check of your records is made to make sure the product meets our high quality standards. When you sign your name on the appropriate records, you are, in essence, becoming an historian for that product. Should you receive a customer complaint, the product history records become very important documents. They allow you to carefully examine each step of the manufacturing process to determine the seriousness of the complaint and decide what action should be taken. When you care enough to make GMP a lifestyle, not just a regulations, you do more than sign records - we
put our name on a job well done. So remember: Write it Down - Keep Good Records.

Note: Some parts of this page may not apply to food manufacturers who follow 21 CFR Part 110.