QUALITY ASSURANCE AT ALIUM
Alium operates in a complex global regulatory environment - patient safety, product efficacy and quality is of paramount importance. We ensure that the medicines we procure, store and distribute fulfil our high standards and are in full compliance with current legislation and guidelines.
The Directors and Senior Management Team at Alium has a continuing commitment to the following objectives:
- To achieve and maintain the highest standards of quality and service in all aspects of work carried out.
- To procure and supply high quality, safe and effective pharmaceutical products that meet or exceed customer expectations in a compliant, timely and cost-effective manner.
- To operate and continuously develop a Quality Management System (QMS) that complies with the regulatory requirements as defined by the Guidelines on Good Manufacturing and Good Distribution Practice of Medicinal Products for Human Use.
- Ensure personnel are fully knowledgeable in the requirements of the QMS relevant to their operational role and responsibilities. Providing sufficient time and resources to follow procedures which are designed to assure quality.
- Ensure customer requirements and expectations are determined, communicated and fulfilled with the aim of achieving complete customer satisfaction.
Alium is licensed and regulated by the Medicines Healthcare products Regulatory Agency (MHRA) and have the following licences:
- Wholesale Dealers Authorisation (Human) – WDA(H) 19054
- Certificate of GDP Compliance
- Manufacturer's Import Authorisation (Investigational Medicinal Products) – MIA(IMP) 19054
- Certificate of GMP Compliance
- Manufacturer's Special Licence - MS 19054
- Controlled Drugs Licence [Schedules II, III, IV (Part 1 & 2), V]
For more information on UK Legislation and Licensing please use the following links
Government Medicines & Healthcare Products Regulatory Agency
MHRA Guidance Note 14, the supply of unlicensed medicinal products (“specials”)
MHRA Guidance Note 14