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.
Our facility located in Lexington, Kentucky is a unique parenteral manufacturing site that uses isolator technology to manufacture sterile products with varying degrees of pharmacological activity in the same facility. The risks associated with handling highly pharmacologically active products (some term as potent or cytotoxic) can cause concern in the industry; however experts in toxicology, industrial hygiene, chemistry, safety, and quality assurance agree that a risk-based approach to safety is most appropriate.1, 2 There are no regulations or guidelines that prescribe a mandated approach or require segregation of products based on pharmacological activity. There is, however, a lot of interpretation and misunderstanding across the industry.
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.
All too often the planning process for clinical supplies begins after the clinical program is set in stone and the clock is ticking. It is not uncommon to have less than 30 days from first discussions to having a requirement for supplies to be at clinic. For this reason many providers can now offer off the shelf solutions using current equipment and technology. While this may be considered acceptable, the consequences of such decisions are often costly not only financially but also because a complex chain of events has initiated that will ultimately prove challenging to undo.