Taken from the APSM website, by Alan Krol
Why are we ethical?
Moorfields Pharmaceuticals’ total focus is on providing high quality medicines for specialist patient care. These are produced in an environment that matches any in the mainstream pharmaceutical industry.
Moorfields Pharmaceuticals are compliant with all regulatory requirements, having full MHRA approval and actually holding five MHRA licenses. These can be found in our licences page. In addition to these approvals, Moorfields manufactures CE marked medical devices. CE approvals, or ISO standards are recognised approvals for the process.
Because Moorfields Pharmaceuticals manufacture sterile products, their facilities are inspected by MHRA every two years, third party customers (e.g. for clinical trial supplies) will also carry out audits and Moorfields carry out regular internal auditing programmes. Records are kept for 5 years and Moorfields take absolute responsibility for the quality of products manufactured.
What standards to we adhere to?
Moorfields Pharmaceuticals operate to cGMP standards and staff remain abreast of the latest interpretation of the requirements for the manufacture of sterile pharmaceutical products through training and attendance of conferences.
All the materials Moorfields Pharmaceuticals source to manufacture Specials come from approved suppliers who are required to meet very high standards of specification.
The system of pharmacovigilance and adverse reporting which is essential for licensed medicines has been voluntarily introduced by Moorfields Pharmaceuticals to cover their unlicensed products as well as their licensed products. Customers are given 24-hour access to speak to a designated person about any problems they may experience, secure in the knowledge that this will be dealt with at the highest level by Head of Quality, who has a direct reporting relationship with the MD.
Why are we useful to society?
Moorfields Pharmaceuticals puts the patient at the absolute centre of what they do, designing the formulation of the product specifically for the intended user and conscious that when the pharmacist calls he has the patient in front of him. Because patients will need their medication to resolve a clinical problem, such as the treatment of an eye infection with a preservative free antibiotic, all Moorfields Pharmaceuticals products are delivered on a next day basis.
Because of the special requirements of patients with compromised eyes, the majority of Moorfields Pharmaceuticals’ formulations are preservative free and products are designed to be buffered to the ideal PH for the eye. This ensures the Special is as well tolerated and as comfortable for the patient to use as possible.
How can we be seen as dynamic?
As is often the case in the development of Specials, the manufacture of Moorfields’ Specials started in the world renowned Moorfields Eye Hospital NHS Foundation Trust and by the mid 1990’s demand began to exceed capacity. For this reason, in 2000 a £12 million investment was made in the brand new purpose built, state of the art facility, which opened in 2004 and from which Moorfields Pharmaceuticals operates today.
More recently, Moorfields Pharmaceuticals has spent a great deal of time developing the highly skilled and experienced customer service team that deals direct with doctors, pharmacists and vets and has begun developing a field force with a remit to support customers and provide feedback so that Moorfields Pharmaceuticals can undertake its commitment to continuous improvement. In recognition of the crucial role that pharmacists play in the supply chain, a specially designed programme is being developed to provide them with additional specialist education on ophthalmology.
How are we patient focused?
Moorfields Pharmaceuticals work very closely with Moorfields Eye hospital’s leading ophthalmic clinicians to develop new products and new methods of delivery. One such productive collaboration has resulted in the formulating together of two ingredients that will allow one less injection in surgery and provide greater convenience for cataract patients.
Moorfields Pharmaceuticals‘ patient focus is further illustrated in an incident that occurred late one Thursday evening when the Technical Director received an urgent request for an unusual ophthalmic antibiotic. The rarely made Special was made and delivered within 16 hours, and since many of these hours were through the night, dedicated staff were to be seen hard at work manufacturing the eye drops at 7am in the morning, having generated batch documents, and before putting the drops through the quality checking process and delivering them to the hospital Pharmacy by Friday lunchtime.
In a groundbreaking new initiative, Moorfields Pharmaceuticals are close to introducing a range of liquid products presented in a unit dose format. The format overcomes many of the problems associated with the limited shelf life of often less than seven days that preservative free Specials have once the bottles are opened. The plastic strip enables single doses of medication to be administered through a super smooth opening and an aperture which is specially designed to gently release a drop of exactly the right size of medication. Thus the patient receives a high quality product, sterile at the point of use.
Why are we reputable?
Moorfield Eye Hospital’s peerless 200 year-old reputation backs up everything that Moorfields Pharmaceuticals do. Records show that Moorfields have been manufacturing unlicensed medicines for over 50 years, which means that the organization has an enviable amount of stability data to draw upon. Because many clinicians train at Moorfields before taking up positions abroad, the hospital has a truly international reputation.
Moorfields has a deliberate policy of spending a great deal of time and effort in training and team building and draws 40 to 50% of staff from the pharmaceutical industry to drive their reputation and ensure that they continue to deliver excellence.