4 Best Practices for Strong cGMP Plant Design
April 22nd, 2013 // 7:16 pm @ jmpickett
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Below are some of the most important aspects of designing a cGMP-compliant drug production facility.
#1 Appropriate cGMP Layout
A good cGMP plant layout has separate areas for the most critical functions of the facility. This is very important for any drug products that have a risk of migrating contaminants throughout the whole plant. The most important thing to do is to make separate the receiving and shipping areas to cut down on the chance of having any cross contamination. A good example is having a U shape to the layout so that there are dedicated docks for different products on each leg. If you can actually separate shipping and receiving, consider putting a wall between those two functions.
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In an ideal world, your warehouse for receiving should be used just for raw, incoming products. You should have a dedicated QA lab there to make sure that the product that is labeled A is really A. You also should conduct tests to make sure there are not any microbiological contaminants. You really need to be sure your drug ingredients are pure before they go to processing.
We also recommend that you use fully dedicated handling machinery, such as forklifts, for each dock. Some of the biggest causes of contamination are forklift and personnel going between dedicated areas in a plant.
#2 Controlling Access
You need to take a close look at how people are coming into your cGMP drug plant and how they get around. Most plants now have a separate entrance for employees and guests, which you should definitely do. Also, you want to make sure you keep truckers and other types of delivery people out of your plant. You do not know them and you do not know what type of drug plant they were in before they came to yours. There is no reason at all to have them in your production area.
You should zone the facility to limit access according to job functions. You can do this with security badges or scanners that verify fingerprints. This will guard against potential cross contamination problems in the manufacturing steps that can compromise your product safety.
We recommend that you have sanitation areas near the area for processing. This way, clean equipment never has to go through dirty parts of the plant as it goes back to the line. If you can, make a utility corridor so your clean equipment does not need to go through other working parts of the plant. Personnel for operations and maintenance should have the ability to sanitize all equipment and get it back to the area of production.
#3 Having Good Building Pressurization
Having your whole plant properly pressurized relative to the outside air means there is little possibility for contaminants in the air to get inside. When there is an open door in a plant that has positive pressure, you will see that air is more likely to escape than to enter. Having good pressurization will prevent bugs from getting into the building too.
This is also the case for room to room inside the building. We find that the production room is the cleanest and it needs to be pressurized positively related to the other parts of the building. The area for production should have a higher pressure than the packaging room. Air should be flowing away from clean rooms to less clean rooms.
Sometimes having separate, isolated air systems are good to cut down on any chance of contamination. This is very important if your plant has a lot of dust and contaminants in the air.
#4 Good Airborne Sanitation
Building codes do provide guidelines for the location of air intakes, but common sense is also a factor. You should not install air intakes over your loading dock or next to a waste disposal area. You also want to think about how good the air is outside. Many large drug plants have air intakes mounted on the roof to save on costs. It is hard to control the quality of the air coming in through these units. A better choice is a central, interior air intake.
Having UV lights in your air handling units will cut down the risk of having airborne contaminants in the plant. The light helps to kill insects and bacteria, and will cut down on mold in the areas around your cooling coils and other critical areas of the air handling units. Having the air in your production room cool and dry will cut down on the growth of airborne contaminants.
You need to educate and train staff about the best cGMP practices in ventilation. A good ventilation system is designed for a static situation, but remember that your daily operations will have personnel, forklifts and materials coming in and out. One example is during the summers when employees cause problems by leaving doors open. This is very common during lunch breaks.
Upcoming FDA cGMP Expertbriefings.com Webinars for 2013 include:
- April 23 – Spend $500K on Compliance or $300 Million on Consent Decree? – Essential cGMP Compliance Tips for Sr. Management
- April 25 – How to Survive PREDICT – FDA’s New Import Screening Program
- April 29 – Audit Your Lab Like an FDA Auditor – A Roadmap to cGMP Lab Compliance
- April 30 – How to Prepare Yourself for 21 CFR Part 11 Inspections
- May 1 – Avoiding Warning Letter Disasters With a Strong cGMP and GCP Quality Agreement
- May 2 – Avoid the CDRH eCopy Confusion – How to Prepare a Compliant eCopy Submission
- May 7 – FDA Recall Chief Update – How to Design a Bulletproof Recall Strategy
- May 15 – FDA Chief Counsel Report – How to Deal With and Avoid Warning Letters
Updated Daily – Read our latest FDA, cGMP Compliance News
