In the pharmaceutical industry, the traceability of prescription drugs is increasingly vital to the integrity of pharmaceutical products. By providing more end-to-end visibility into pharma supply chains, companies can better trace serialized products from wholesalers to end customers, enhancing the reliability of supply deliveries while also offering a way to detect counterfeit drugs and track…

One of the overarching themes emerging from the survey was the need for a single, centralized platform for label design, change control, printing, integration and management to overcome the challenges: “Only 14% of those surveyed have achieved 100% integration with their MES/ERP system. Over 34% are still using separate systems to manage their labeling and…

Although standard “office” labels are more than sufficient for routine applications like filing, addressing envelopes, and shipping boxes, they are not designed to withstand the range of conditions and hazards found in harsh industrial settings such as warehouses, production lines, laboratories, or construction sites. Fortunately, film labels are available that are engineered to withstand harsh…

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that is used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. DMFs typically contain critical details required in support of the Chemistry, Manufacturing, and Controls (CMC) elements within a regulatory…

Q: Materials handling seems to be growing in complexity in today’s manufacturing world, especially hazardous production materials. Can you offer some thoughts about key things to consider in relation to handling, as well as facility design and renovations? A: “Fools ignore complexity. Pragmatists suffer it. Some can avoid it. Geniuses remove it.” Alan Perlis While…

In work that could help make possible a faster, longer-lasting, and lower-energy method of data storage for consumers and businesses, researchers at the National Institute of Standards and Technology (NIST) and their colleagues have developed a technique for imaging and studying a promising class of magnetic devices with 10 times more detail than optical microscopes.…

The FDA’s emphasis on laboratory audits in recent years has focused on companies confirming that laboratory data is not fraudulent. With the rise in evidence that justifies the FDA’s fraudulent data concerns — especially internationally — the failure of companies to provide established historical information and ensure compliance on the validation of their analytical methods…

The FDA’s emphasis on laboratory audits in recent years has focused on companies confirming that laboratory data is not fraudulent.

Filtration media technology continues to evolve past traditional materials of construction (e.g. fiberglass fibers) into membranes such as ePTFE and other new materials. This evolution and other advancements result in an industry-wide need for leading-edge documents containing the most current testing and industry practices.

Cleanrooms are a vital part of laboratories and the microelectronics industry, especially semiconductor manufacturing. To maintain and assure quality, there are specific standards that apply to these spaces and guide the process of constructing and operating the rooms. While adhering to these requirements makes designing and constructing a cleanroom more complex than conventional construction projects,…

A study funded by the U.S. Occupational Safety and Health Administration (OSHA) entitled Health and Safety in the Cleaning Services Industry was released in 2009. The study found that the number of Hispanic workers injured on the job in the U.S., when compared to non-Hispanics and whites, was considerably higher. And as far as work-related deaths, the study also reported, “In the United…

Controlled Environments spoke with Richard Aleman, VP Regulatory Compliance at Pharmatech Associates, a Hayward, Calif.-based company that provides consulting and services to the regulated life science industry. Richard began his career with the FDA as an investigator in Dallas, TX in 1972. He has more than 25 years of Supervisory/Management experience in the regulatory and enforcement…

​Cybersecurity considerations have been part of designing an effective Good Manufacturing Practice (GMP) network since the FDA issued its first computerized validation guidance in the 1980s. With FDA’s renewed interest in ensuring data integrity at home and across the global supply chain, what is complicating the cybersecurity discussion today is exposure to threats that come from the interconnectivity that defines modern business. From laptops to smartphones…

For nearly 10 years, the ISO 14644-1 and ISO 14644-2 standards have been reviewed and revised. Recently the members of ISO Technical Committee (ISO/TC) 209 approved the latest revisions to ISO 14644, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness and Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration. The Convener of…

The science-based standards of the U.S. Pharmacopeia (USP) are used and relied upon worldwide. They regulate and set quality control standards for the thousands of drugs produced annually by the multi-billion-dollar pharmaceutical industry. The USP requires pharmaceutical and biopharmaceutical manufacturers making injections and infusions to follow their stringent rules regarding the quantity of particles present in the final drug product. Further, it recommends that liquid…