Before a GMP manufacturing facility implements a software system into their operations, that system must go through a comprehensive software validation process. This multi-part process ensures that a manufacturing facility’s software is…
Maintaining GMP and FDA compliance is crucial to the operations of any pharmaceutical, dietary supplement or biotech manufacturer. To ensure that manufacturers are in compliance with all current regulations and standards, the…
The Electronic Batch Record (EBR) software Industry was the focus of a recent report published by QY Research. This in-depth market analysis of manufacturing execution systems reviewed the current trends, financials, historical…
The responsibilities of contract manufacturing organizations (CMO) go beyond simply producing quality products for their clients. They must also be open to collaborating with them while providing clear lines of communication and…
The goals of any manufacturing company that adheres to Good Manufacturing Practices (GMP) are to effectively, efficiently and accurately produce quality products that are safe for the end customer. However, manufacturers that…
As the leading provider of software solutions for manufacturers, InstantGMP™ is always looking for ways to enhance our products to improve efficiencies, increase productivity, provide greater accuracy and control, and ensure compliance with…
Establishing and depending on a quality system is vital for any facility to ensure Good Manufacturing Practices (GMP) compliance. Without an accurate quality system in place, the risk of error that results…
Master Production Records (MPR) are the foundation for all good manufacturing practices. While sometimes referred to by a variety of other names (Master Records, Master Manufacturing Formulas, Master Formula Records, Master Manufacturing…
From inception to creation to release, InstantGMP™ PRO’s goal was to execute all the necessary Good Manufacturing Practices processes via stand-alone software. Years later, InstantGMP™ PRO software continues to stand alone as…
Manufacturing RNA-engineered cell therapies is not only complex - it’s incredibly expensive. Most cell therapy companies rely on contract manufacturers to complete the process that typically totals $150,000 in final costs. And…
Standard Operating Procedures (SOPs) are an integral part of regulatory compliance for any facility that adheres to Good Manufacturing Practices. These documents ensure consistency and accuracy in every step of the production…
Being Good Manufacturing Practices (GMP) certified is vital for any manufacturing facility’s success. This certification identifies manufacturers who are fully compliant with all FDA regulations and have the necessary systems in place…
In the manufacturing industry costing is crucial. The financials of every element that goes into producing a batch has to be considered. From material costs to operator hours to testing time to…
Upon its arrival, InstantGMP™ PRO revolutionized the industry by eliminating the reliance on purchasing several pieces of expensive software to perform all the necessary processes that support Good Manufacturing Practices. With this…
The switch from paper-based systems to electronic systems was a major advancement for the manufacturing, packaging, distribution and wholesale industries. Gone were the days of physically writing and storing the various documents…
As the foundation for good manufacturing practices, a Master Production Record (MPR) defines the necessary steps manufacturers must take to produce everything from pharmaceuticals to dietary supplements. It’s the manufacturing process equivalent…
Document management systems (DMS) need repositories for both controlled and uncontrolled documentation. Any company that is required to comply with GMP ("Good Manufacturing Practice" quality guidelines and regulations) must have a comprehensive…
Master Production Records (MPR) give the planning department a starting point for determining the materials required for inventory, while Batch Production Records (BPR) consume the inventory during manufacturing. Cutting-edge businesses often store…
One of the cornerstones of an inventory management system is documentation, such as shipping manifests. Especially in the highly regulated cannabis, pharmaceutical, and biologics industries, generating accurate shipping manifests ensures robust inventory…
The COVID crisis has done many things, but in particular, it has showcased the vastness and complexity of modern supply chain management. The branches of the modern supply chain extend far and…
Too many virtual biotech companies are working with disjoined systems trying to manage a variety of contractors and vendors. While doing so, they are working to continually fund their manufacturing and clinical…
The FDA holds virtual biotech companies accountable for the clinical trials they sponsor. If a problem is to arise during a clinical trial, those who use a quality management system are more…
To succeed today businesses must quickly onboard and train new employees, and simultaneously, keep current employees up-to-date with ever evolving procedures and protocols. As the world of work continues to evolve at…