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When it comes to manufacturing, there are six big losses: Total productive maintenance (TPM) aims to eliminate all these losses—completely, to maximize overall equipment effectiveness (OEE). I spoke with Duncan Cole, Project Manager at Wolters Kluwer Enablon, about the singular impact that these losses can have on the pharmaceutical production process and the end product. Even though it wouldn’t impact a person, because this product wasn’t directly going into a tablet and the seal fluid was classed as fit for human consumption, we still needed to plan a way to remove the seal fluid contamination. The problem being at this point, the team couldn’t actually do anything to clean/re-work the batches, and this was basically because of the complicated nature of the re-work process meaning it was counterproductive to actually try to do this and would in fact cost more without the guarantee of success.

The ‘S’ in ESG Gains Currency,” writes “Companies are making progress in disclosing their environmental impact and governance standards, but social factors have not been given the same attention — until now. Unlike environmental and governance issues, which are more easily defined, have an established track record of market data, and are often accompanied by robust regulation, social issues are less tangible, with less mature data to show how they can impact a company The purpose of a corporation is to maximize financial returns for its shareholders, but also to deliver value to customers, invest in employees, deal ethically with suppliers, and support the communities where they work. So they began offering free classes such as: English as a Second Language, High School Equivalency, U. S. citizenship, financial literacy and digital literacy.

As the provider of the world’s leading technology platform for EHS and Operational Risk Management (ORM), the convergence of EHS and Operations is a topic that we talk a lot about. “Management of Change” to a professional in Oil and Gas, Chemicals, or Industrial Manufacturing, and most of them will associate it with OSHA’s Process Safety Management standard, and rightly so. Any change creates some form of risk, whether it’s a change in equipment, personnel, products, procedures, or a change to the design of a plant floor. The EHS team may have to assess whether the changes impact social distancing rules (2 meters between each employee, need for extra plexiglass dividers, etc.), whether the maximum capacity of that particular work area is impacted, and whether there are any potential impacts on air quality (e.g. need for different indoor air filters if there are more people in the area).In summary, it’s time to look at Management of Change as a key business function, not just as one element of Process Safety Management.

Though, these companies also want to avoid costly recalls and investigations if the affected product gets to market—investigations and lawsuits that could drag on endlessly for years and continue to rise into billions of dollars. Costs exponentially go up by 100 if the defective product then gets distributed, requiring a detailed recall and investigation process, on top of the potentially devastating consequences of harming a patient. Many costs go undetected because of poor business practices and, quite simply, an inability to accurately report on processes. The Importance of GMP and Traceability in Pharmaceuticals ManufacturingGMP guidelines ensure high quality from batch to batch, with the main purpose to prevent harm to the end user, with an emphasis on process traceability.