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When it comes to manufacturing pharmaceuticals quality is critical. Following current Good Manufacturing Practices (cGMP) can help ensure that nothing goes wrong, as these practices lay the foundation for creating quality products. In most countries, cGMP is one of the conditions a company must meet to be allowed to sell its products in one jurisdiction or another.

Any deviation from the standard operating procedure could result in the release of contaminated medications or worse, which could result in the loss of an entire batch of product, leading to potential drug shortages and lost profit, among other things.

Types of Batch Records in Pharmaceutical Manufacturing
The batch manufacturing record (BMR) isa document containingthe instructions that must be followed when manufacturing medication. It includes information like product name, weight and count of each component in the medication, a list of all processes and procedures to follow, and the expected yield of each batch. Essentially, the BMR is the template for producing a drug and so it must be followed with precision and care.

What is a Batch Production Record?
Unlike the BMR, which outlines the manufacturing process, the Batch Production Record (BPR) is a complete history of each stage of the pharmaceutical manufacturing process for each lot, or batch, of medication produced. In essence, it’s a kind of checklist to ensure the instructions in the BMR are followed by everyone involved in the manufacturing process. It exists to provide proof that the BMR was addressed, which is key because, as the FDA states in their guidelines, “If it’s not written down, it didn’t happen.”

Why are BMRs so important?
BMRs detail the manufacturing process to ensure it is efficient, successful, and compliant. Those involved in the process have accurate instruction on things like maintenance, product components preparation, and quantities, among other things.

The Anatomy of a Perfect Batch Manufacturing Record
While the details are different for every product that is produced in a manufacturing facility, the required details of a BMR are the same.

Streamlining Batch Records Review with eBMR & What’s Next
Current practices for BMRs involve a lot of paper records (yes, spreadsheets are still considered paper). These, along with being time-consuming to fill out and manage, don’t give manufacturers easy access to invaluable data. Data they can use to streamline processes and reduce costs, while improving the quality of their batch runs.

Batch Management Dashboard

When you combine the information collected during the manufacturing process with data from the rest of the company, you unlock the potential that all of that data contains. By analyzing all of this combined data, it becomes possible to find operational efficiencies that can help streamline the manufacturing process, reduce costs, and help eliminate human error.

Taking steps towards the future
With the right technology in place and a healthy attitude towards digital transformation, it’s possible for pharmaceutical manufacturers to grow their business. It’s not only about creating a better batch production instructions and documentation processes. It’s about growing the bottom line.

Dot Compliance offers a feature-rich quality assurance and batch record management suite with record-fast deployment speeds and cutting-edge analytics capabilities. Contact us for a demo and discover how our quality management system can help you grow your business and maintain compliance.

When you have taken the time to read this article, chances are you want to be well informed about dental health. You thought of going through the post because your dentist has referred to an endodontist in Springfield, VA and you want to learn more. Here you get to know the difference between a dentist and an endodontist and why you need to visit the later one.

Endodontists are a specialist lot. Just think of as equivalent to the relationship between a doctor and a cardiologist or a doctor and a gynecologist. Basically one is a general practitioner while the other is a specialist. All cardiologists are doctors but not all doctors are cardiologists. In the same way, the American Association of Endodontists states that all endodontists are dentists but only a few dentists are endodontists. Endodontists are referred to as specialists as they have undergone a few more years of specialized training after completing 4 years of dental school.

Although endodontists in Springfield, VA, and general dentists have some overlapping practice areas, however, both treat different dental problems. Endodontists do not clean teeth or place fillings. They perform root canal treatments and other methods related to the tooth pulp and the interior of the tooth that they have learned during the additional training. They are highly skilled professionals dedicated to preserving your teeth. In the majority of the cases, a diseased tooth can be cured with endodontic treatment. If you require a root canal, you may think your dentist will do the treatment. Although the dentist can do it perfectly well, the person may only perform two or three in a week. So, many dentists refer their patients to endodontists as they do an average of 25 root canal treatments per week. Moreover, they are skilled in the updated technology and techniques for painless and smooth root canal treatments.

Many patients get nervous about root canal treatments and endodontists know it very well and are experts in managing the pain and interested to set straight the belief that root canal treatments are tedious and painful. They always ensure that patients feel comfortable during treatments. They are equipped with high-end materials and equipment for making root canals easy and successful. Many endodontists also use the laser during the treatment as they are effective, painless and quiet. There is reputed endodontics in Springfield where the team is specialized to treat problems the inner part of the mouth and also provides tips for maintaining good oral health. Moreover, endodontists in Springfield, VA provide a safe environment for the patients and every member is dedicated to providing excellent patient care. They also focus on building healthy relationships with referring specialists and dentists.

Due to advancement in endodontics, endodontists can be able to use innovative technology for treating and saving your teeth that have suffered damage to your soft tissue present inside the roots of the tooth. Moreover, these highly skilled individuals do your treatment without causing much pain.