Melbourn Scientific, a leading provider of analytical and formulation support for the pharma and biotech industries, has once again completed a successful UK MHRA GMP (Good Manufacturing Practices) audit providing a seal of approval for its services.
Carol Barbour, Director of Quality, explains that as an approved contract testing laboratory, clients can identify Melbourn as a testing facility on their manufacturing licence applications and be confident in knowing that the facility is acceptable to the authorities reviewing their application.
“GMP is mandatory for various later stages in the development of pharmaceuticals therefore using us as a partner in drug development programmes will enable small companies and larger pharmas to fast track their products through to release, maximising the benefit achieved from early approval of products. There are also advantages where clients are at an earlier stage in the development process."
“Although early research does not need to be performed in accordance with GMP, having work performed to a recognised Quality Standard gives confidence in the results, helping facilitate any due diligence processes if IP is being shared with external partners and potentially increasing the value placed on this data.”
Melbourn is currently expanding its facilities for work on early stage formulation development by the creation of a suite of rooms specifically for this function. These rooms will allow flexibility to support multiple projects running at the same time.
“By offering our clients analysis, formulation development and small-scale production on one site, it is possible to screen a wide range of formulations, in a cost and time effective manner, in order to identify those most likely to succeed,” Carol continues.
The MHRA is the regulatory body within the UK which scrutinises all licensed medicines in the UK to ensure that medicines meet acceptable standards on safety, quality and efficacy, and therefore protect the health of the public. It audits all companies working within this area to assess the compliance of the facilities with GMP and to assure the integrity of the data being submitted.
Having a successful audit confirms that a facility is working in compliance with GMP and gives clients added confidence in the work performed on their behalf.
About Melbourn Scientific www.melbournscientific.com
Melbourn Scientific provides high quality analytical and formulation services to the pharmaceutical and healthcare industry. Clients include major pharmaceutical companies, drug delivery innovators, consultants and virtual companies.
Melbourn Scientific has invested continually in the latest equipment and provides a range of services: pharmaceutical analysis, physical testing; stability trials; HPLC and inhaled product analysis.
Carol Barbour, Director of Quality, explains that as an approved contract testing laboratory, clients can identify Melbourn as a testing facility on their manufacturing licence applications and be confident in knowing that the facility is acceptable to the authorities reviewing their application.
“GMP is mandatory for various later stages in the development of pharmaceuticals therefore using us as a partner in drug development programmes will enable small companies and larger pharmas to fast track their products through to release, maximising the benefit achieved from early approval of products. There are also advantages where clients are at an earlier stage in the development process."
“Although early research does not need to be performed in accordance with GMP, having work performed to a recognised Quality Standard gives confidence in the results, helping facilitate any due diligence processes if IP is being shared with external partners and potentially increasing the value placed on this data.”
Melbourn is currently expanding its facilities for work on early stage formulation development by the creation of a suite of rooms specifically for this function. These rooms will allow flexibility to support multiple projects running at the same time.
“By offering our clients analysis, formulation development and small-scale production on one site, it is possible to screen a wide range of formulations, in a cost and time effective manner, in order to identify those most likely to succeed,” Carol continues.
The MHRA is the regulatory body within the UK which scrutinises all licensed medicines in the UK to ensure that medicines meet acceptable standards on safety, quality and efficacy, and therefore protect the health of the public. It audits all companies working within this area to assess the compliance of the facilities with GMP and to assure the integrity of the data being submitted.
Having a successful audit confirms that a facility is working in compliance with GMP and gives clients added confidence in the work performed on their behalf.
About Melbourn Scientific www.melbournscientific.com
Melbourn Scientific provides high quality analytical and formulation services to the pharmaceutical and healthcare industry. Clients include major pharmaceutical companies, drug delivery innovators, consultants and virtual companies.
Melbourn Scientific has invested continually in the latest equipment and provides a range of services: pharmaceutical analysis, physical testing; stability trials; HPLC and inhaled product analysis.
