How to Review Pharmaceutical Manufacturing Records for Compliance

Activities from the pharmaceutical manufacturing process is documented in a batch record. The main purpose of the batch record is to have written proof of what was added to make the pharmaceutical product. Good Manufacturing Practices, referred to as (current GMPs written as cGMP) are laws that dictate certain criteria to be followed when making drug products. This article will focus on how an auditor reviews pharmaceutical manufacturing records for compliance to FDA regulations.

Things You'll Need

• Advanced knowledge of Good Manufacturing Practices (cGMP)

Instructions

1. Learn cGMPs.

   First, you need to know U.S. Title 21 CFR Parts 210 and 211 for manufacturing drug products. Drug manufacturers also use six-sigma and ISO-9002 guidelines when manufacturing products to ensure the highest level of quality. Following these parameters reassures the FDA and the sponsor that the product manufactured for human consumption is as safe as it can be.

   to understand the pharmaceutical manufacturing process, think about baking a cake. To cook a cake, you need ingredients and you need to know how much of each ingredient to add. Making a drug product is very similar. Instead of calling it "ingredients", we call them "components", but the ideology is the same. The company manufacturing the drug product must write down what was added and the amount of each item that was added. This information is recorded in a batch record. Most manufacturing is performed automatically using process manufacturing software. However, the Operator is expected to record temperature readings, weights, equipment iedntification and several other required information into the batch record. Everything that happens during the manufacturing process must be documented - even if it is as simple as the lights going out. By documenting what occurred while making the drug; the FDA and the company can determine if the product was made the way it is suppose to be made and whether it meets regulatory requirements.

2. Look at What was Done.

   The person typically overseeing the process and adding and mixing the omponents is called an "Operator". Compare the steps performed and documented by the Operator during the manufacturing process with what the regulations states should be done. For example, if the regulations require weights be written for each ingredient added to the "pot"; verify that each ingredient has a weight recorded. If the regulation require a second signature for the ingredient's added, look at the record and make sure a second signature is present. Determining GMP compliance is always the reviewer's goal. Just make sure the product was made the way the batch record instructed.

3. Performing the Actual Review.

   Regulations require that a Quality Assurance (QA) person, who is independent of the people making the drug product, conduct the compliance review. The QA person should verify that each requirement in the regulation was met while the drug was being made. They should also verify that the process and requirements listed in the batch record were completed. If not, there must be a documented explanation and the record is returned to the production facility for completion and corrections, as applicable.

4. Confirm Lab Results in Batch Record.

   In addition to ensuring the ingredients were added as required, the QA person compares the batch record laboratory results to the actual laboratory printed report and ensure the results were accurately transferred from the report to the batch record. Once the QA person has verified that everything was properly completed and documented in the manufacturing batch record, they must sign the document as approve and released so the production unit can package the pharmaceutical product for storage and shipment.

5. Compliance reviews are very important to pharmaceutial manufacturing. By reviewing the batch record, Quality Assurance have an opportunity to catch errors before the product is released for public consumption or before an error cost the company thousands of dollars.

Resources

• Food and Drug Administration
• How to Write Standard Operating Procedures
• How to Create FDA Auditable Source Documents