Why spare the drug companies

Paul Fehlner, the chief legal officer for biotech company Axcella and a supporter of the WHO patent pool board, said governments that poured billions of dollars into developing vaccines and treatments should have demanded more from the companies they were financing from the beginning. Last month, Dr. Anthony Fauci, the leading pandemic expert in the United States, said all options need to be on the table, including improving production capacity in the developing world and working with pharmaceuticals to relax their patents.

But Suhaib Siddiqi, former director of chemistry at Moderna, said with the blueprint and technical advice, a modern factory should be able to get vaccine production going in at most three to four months. Back in Bangladesh, the Incepta factory tried to get what it needed to make more vaccines in two ways, by offering its production lines to Moderna and by reaching out to a WHO partner.

Muktadir said he fully appreciates the extraordinary scientific achievement involved in the creation of vaccines this year, wants the rest of the world to be able to share in it, and is willing to pay a fair price. Maria Cheng reported from Toronto. Jamey Keaten in Geneva, Jan M. Sections U. Science Technology Business U. Countries urge drug companies to share vaccine know-how.

A member of production checks cell growth and viability of a bioreactor sample under an inverted microscope inside the Incepta plant on the outskirts of Dhaka in Bangladesh Saturday Feb. Accurate reordering is reliant upon accurate issues. An open Storeroom, where technicians retrieve their own parts, can make accuracy in issuing a challenge. First the inventory is off on the item taken, secondly, an item is reordered when it was not required.

Regulatory agencies are not, in principle, concerned with inventory accuracy it may be considered, however, as a lack of control , but they are attentive to reverse traceability. If an instrument was calibrated using a consumable standard in inventory, then the details, e. Anyone who has had to conduct investigations regarding use and installation parts, will be familiar with the effort to ascertain if the correct item has been installed in the equipment in question.

Receiving and inspection procedures are necessary for the consistent and standardized methods to onboard parts correctly. This is the first chance to discover where mistakes may have been made. The person conducting this act should be the one responsible for managing the inventory. If the receiving is done at another location and by another department, then errors will slip through and sometimes may not become detected. Most CMMS systems have the functionality to accommodate a second check inspection.

This can be configured with an e-sig and audit trail report. These instructions will form the foundation of practices and procedures to be followed to operate this Life Sciences Spare Parts Storeroom in a consistent and compliant manner.

Setting up a GXP compliant Spare Parts Storeroom is an investment that will pay out every time an inspection is scheduled. A clean, well laid out, organized facility will provide the assurance to an Investigator that this inventory is under tight control and follows established standard processes. The recommendation to put all parts possible into plastic closable bags has a number of benefits:.

Treating the Spare Parts Storeroom as a critical Quality System Element, like many other processes involved with the manufacture of drug products, will ensure that procedures will be followed, and that the operation will function more efficiently and effectively. Many other more granular aspects of this endeavor will become apparent, but the first step is looking at the Storeroom anew and mapping out current state to future state paths. Another facet of the Spare Parts Storeroom is the significant investment it holds, as well as the impact it can have on the overall efficiency of Maintenance.

The following dialogue will shed light on how this operation can benefit an organization through the implementation of some well-established, comprehensive practices. This may be calculated by the on-hand quantity multiplied by a unit cost. This can be one of three cost values, initial or standard cost, last price paid, or average price.

Each has nuances and will be selected according to your company policies. By a judicial and careful examination of the inventory levels and costs, a person can change that figure and by doing so reduce the overhead cost for the Corporation. So, if we can establish a data point of Inventory Value, we can then assign a cost of holding for that population of parts.

That will become part of the formula for an aggressive inventory optimization process. This figure will include a multitude of elements like payroll, utilities, the cost of capital, etc. A report by anti-poverty campaigners published in February said that rich countries have secured more than a billion more doses than they need, highlighting the divide between rich and poor.

Big drug companies oppose patent waivers, with the Pharmaceutical Research and Manufacturers of America, or PhRMA, saying there is no evidence it would boost vaccine production or access. It said in a letter to U. President Joe Biden on March 5 that eliminating protections would undermine the global response to the pandemic, including efforts to tackle new variants, create confusion that could hurt public confidence in vaccine safety and create a barrier to information sharing.

Britain, Switzerland and the United States, home to big pharmaceutical industries, dislike it too.