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.
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.
The manufacture of parenteral pharmaceuticals is a high stakes endeavor because any product imperfections, whether chemical or biologic in nature, are equally as bioavailable as the active ingredients. Patient safety and product quality are always a concern in pharemaceutical manufacturing, however, the risks are amplified for parenteral products that in many cases are directly injected into the bloodstream. This means the impact of product quality risks are higher than for any other pharmaceutical presentation. The use of isolator technology is a state-of-the-art engineering solution to mitigate manufacturing risks, improve the safety of injectable drug products, and provide a measure of safety to those who are manufacturing the products.
Studies of extractable and leachable components (E&L) within packaging systems and pharmaceutical container closures have become mandatory to meet the safety requirements for marketed medicines over the past two decades. The regulatory guidance for E&L provides only general recommendations to ensure safety. The development and analysis of E&L for inhalation, ophthalmic, and injectable drug products is challenging since studying them depends on the type of formulation and packaging material being used.
Cancer is a widely known disease involving abnormal and uncontrolled cell proliferation resulting in solid tumor development or blood cancer conditions. Therefore, when it comes to fighting cancer, the aim is to kill the cancerous cells and/or inhibit the uncontrolled proliferation.
At Piramal Pharma Solutions customer satisfaction is of utmost importance and we strive to meet our customers’ needs in every way we can. Our main goal is to deliver quality products within scope while still keeping budgets and timelines under control. One of the ways Piramal Pharma Solutions does this is by training project managers on best practices in the project management industry; an effective way to learn this methodology and keep current on best practices is to obtain a Project Management Professional (PMP) certification.
Cleaning verification represents the start and finish of each batch in pharmaceutical manufacturing. Two commonly applied analytical approaches to verify pharmacological cleanliness are: total organic carbon (TOC) and high-performance liquid chromatography (HPLC). TOC is a non-specific technique with analysis times ranging from 2 to 10 minutes, depending on the analytical instrument. HPLC has the advantages that methods can be developed for specific analytes and the limit of detection can be one to two orders of magnitude lower than TOC. Due to this, HPLC-UV is a popular cleaning verification (CV) method.