One of the top 5 most often cited FDA violations is for missing procedures or inadequate procedures or quality systems. B&R offers a broad range of solutions to assist firms that include:
- Gap Assessment – Let us help you understand where any deficiencies or weakness in your procedures and quality systems are, and then help you set priorities for improvement.
- Procedure Manual Templates – We have on-the-shelf generic templates for procedure manuals that cover traditional true batch operation as well as continuous batch operations. These templates include key form templates for items such as batch records, material and component receipt, management of change, complaints, recalls and more.
- Update Your Existing Systems – B&R can update your existing procedures to meet current FDA regulatory requirements. We can take this kind of project on as a turnkey project, or we can provide you with the updates needed for each procedure, and you can update your procedures.
- Turnkey Compliance Packages – From our extensive procedure library we can assemble a turnkey program. This option is often the best for firms new to the drug industry.
- Medical Gas Compliance Program – We offer a complete compliance program, often referred to as “Compliance In A Box”. This program has been shown to meet all FDA requirements and comes with everything a medical gas firm needs, right down to the file folders.
Medical Gas Compliance Program
A Complete System – The B&R manual is fully developed and ready to go. You do not have to assemble your SOP manual from a cut and paste library of procedures, hoping you make the right choices for your business and compliance needs. It comes with your company name and logo on the procedures and forms.
Modularized Manual – Our SOP Manual allows you to select the operating procedures you need to fit your business. You can select from the following manufacturing modules. No matter what you need, we have it.
No More Tracking Regulations – At B&R we regularly monitor all FDA and industry activity related to medical gases. We ensure our customers are kept informed of the latest information regarding medical gas compliance.
Automatic Updates – As FDA requirements change, industry practices evolve, or enforcement trends emerge B&R Compliance Associates ensures that your SOP manual is always up to date with the latest procedures and data.