According to a report by the FDA (FY2010), the third most common reason for a 483 (violation) was because of inadequate content of investigations or not completing an investigation in a timely manner. One of the most common mistakes made by the writers of these reports was incomplete investigations which led to poorly written investigations. The FDA requires an investigation to be meaningful, thorough, timely, unbiased, well-documented, and scientifically sound.
Failure mode effects analysis (FMEA) is a form of risk assessment using a step-by-step approach to identify possible failures in a design, process, and/or product enabling analysis to eliminate or reduce future failures. This type of assessment was first used by the US military in the 1940s and further developed by the aerospace and automotive industries. Although engineers have performed various forms of FMEA on their designs and processes for years, it has just recently become a regular technique for risk assessment in the pharmaceutical industry.
A goal of any pharmaceutical manufacturer is the pursuit of the most efficient equipment available. This equipment can increase output, reduce downtime, cut costs, and increase overall productivity while also adhering to strict cGMP requirements. The acquisition of this type of efficient equipment is the main purpose of the expansion at Piramal Pharma Solutions, Lexington, Kentucky.
According to recent trends in the market, the global contract pharmaceutical manufacturing industry is increasing at an average annual rate of 7.5% and is predicted to reach $79.24 billion in revenue by the year 2019. The market research firm, Visiongain, also expects a strong expansion in revenue for these companies to continue through 2025. Some key drivers in this growth include a growing demand for treatments based on highly potent active pharmaceutical ingredients (API) and regenerative medicines.
In Atlanta, Georgia, the Boys & Girls Club decided to do a Christmas experiment. 83% of the children that attend the B&G Club are low-income with some of the families not even being able to afford a Christmas tree. The children were asked what one thing they really wanted for Christmas this year. Then, they were asked what they think their mom or dad would want for Christmas. Most of them gave very thoughtful answers like a new dress for their mom, or a TV for their Dad because they do not have one, or even just a coffee pot. The children were presented with both gifts but told they could only have one of them – either the gift for themselves or the gift for their families. Every single child picked the present for their families over the gift they wanted most. There is a happy ending though as the children were given both gifts in the end.
Lyophilization is a process in which water is removed from a product after it is frozen and placed under a vacuum allowing the ice to change directly from solid to vapor without passing through a liquid phase. Typically, this dehydration process is used to preserve a perishable material and/or make the material more convenient for transport. The process usually involves three phases consisting of freezing, sublimation, and desorption.
Technical writing is not a new idea. Any type of communication written for and about industry and business with a focus on products and/or services is technical writing. Almost everyone within a company has written a form of technical document – from the résumé that was submitted to gain employment to the email sent to a co-worker to writing an investigative report. According to a survey of business leaders, as many as two-thirds of salaried employees have some writing responsibility, and all employees must have writing ability, especially with the increase in company email communication.