![]() ![]() In reality, demonstrating a robust product understanding not only underpins a successful submission but also lays the foundation for the effective supply selection and process troubleshooting needed for long-term economic manufacture. But establishing a more comprehensive package of measurements for APIs or formulation is entirely consistent with the QbD approach and can pay dividends throughout the lifetime of a product. The risk of making such requests, however, is that that they may drive up the cost of outsourcing. Rather than dictating conversations with requests like, “I’d like to measure the particle size of these granules by laser diffraction”, companies should consider making more open-ended requests such as, “I’d like to characterize these granules to develop correlations between their properties and those of tablets manufactured from them”. Though companies hold the expectation that outsourcing partners will be able to provide high-quality data in a closely specified timeframe – at competitive prices – a question remains: how do you develop a relationship that best draws upon the strengths of both parties? In my experience, making broad requests of a contract lab offers their experts greater scope to contribute as an equal partner in the research process. In 2018, the global pharmaceutical analytical testing outsourcing market was valued at $5.59 billion and is set to grow by 8.1 percent over the next seven years. Choosing a good contract laboratory or analytical service gives you access to a broad range of equipment as well as in-depth expertise. The accrual of savings holds value for many as the need to invest in and use new instrumentation and train staff falls away. In fact, in 2018, the global pharmaceutical analytical testing outsourcing market was valued at $5.59 billion and is set to grow by 8.1 percent over the next seven years (2). The challenges are significant, so many companies choose to outsource their analytical testing. And beyond CQAs and CMAs may lie many additional variables – powder flowability, porosity and specific surface area, for example, depending on the pharmaceutical product type, can affect development and manufacturing and are, therefore, valuable to measure. The knowledge accrued is also helpful for ensuring secure optimization of the supply chain (1). Though potentially demanding, it facilitates a more flexible regulatory approach – an important consideration when putting together the robust submission package required. QbD places emphasis on process and product understanding, and is intended to reduce risk. ![]() How do you choose which properties to measure when it comes to characterizing APIs, excipients, or even the formulation? The identification of critical quality attributes (CQAs) and critical material attributes (CMAs) is an integral component of Quality by Design (QbD) but decisions around how best to measure them are not always easily made in-house. More than 12,000 punters chose to place their bets via the TABs internet wagering channel. “Sculptor’s success in the SAAB Quality and Efficient’s big win in the 2007 Emirates Melbourne Cup also saw Kiwi punters finally get one up on the Aussies claiming a sizeable share of the SuperTAB pool between both feature races,” said Michael.Ī total of $7.3 million was bet with the New Zealand TAB on the Melbourne Cup. “Similarly, had Sculptor won the Melbourne Cup Kiwi punters would have received NZ$24.90 for a win compared to NZ$7.10 in a stand alone New Zealand pool. ![]() This made a big difference to dividends, for example, Kiwi punters placing a bet on Efficient to win the Melbourne Cup received a dividend of NZ$ 22.40 – if it had been a stand alone New Zealand pool Kiwi punters would have received NZ$19.80. “The combined SuperTAB win pool for the Melbourne Cup was $24.65 million compared to the New Zealand TABs $3 million win pool the previous year. “For the first time ever, Kiwi punters were able to bet into the combined New Zealand and Australian SuperTAB pool which provided much better opportunities to follow New Zealand bred, trained and owned horses. The New Zealand Racing Board’s Racing Manager, Michael Dore, said this years Melbourne Cup offered an added bonus for Kiwi punters through the introduction of commingled pools. ![]() Combined betting pools and a strong contingent of New Zealand bred, trained and owned horses provided plenty of entertainment for Kiwi punters in this year’s Melbourne Cup Carnival. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |