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RMS Regrow bags 3 major certifications from international accredited body, BSI
Our Bureau, Hyderabad | Thursday, September 15, 2011, 08:00 Hrs  [IST]

Regenerative Medical Services (RMS) Pvt. Ltd. a leading Biotechnology company in India has bagged 3 major certifications, Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) from the International Accredited Body - BSI (British Standard Institution).

RMS Regrow’s main focus is delivering Stem Cell therapy treatment. It is the only company in India which is conducting research on advanced cell therapy treatments and Cord Blood Banking (Babycell). Through its Stem Cell Processing Centre, the firm offers autologous cartilage and bone cell therapeutics to patients. It also aims at applying regenerative medicines to bring effective patient specific therapeutics to bed side.

With the GMP, GLP and GCP certifications, RMS Regrow is placed in the select league of companies in the world complying with standard procedures that are approved international body. There are very few companies in India that have acquired such standards in quality especially in the commercial delivery of Cellular Therapies & Stem Cell Banking.

“This is a landmark achievement for us. It will enable us to advance the global commercialization of cellular therapies, live up to the commitment of customer expectations and maintaining manufacturing excellence” said Dr Satyen Sanghavi, chief scientific officer at RMS.

In the present context of global business, Good Manufacturing Practice [GMP] is an important regulatory requirement for the medicine manufacturing firms. It gives them worldwide recognition for their quality products. Under GMP guidelines, all critical processes are validated to ensure consistency and compliance with specifications. GMP are the systems required to be adapted in development, quality control, quality system covering the manufacture and testing of medical therapies & drugs including active pharmaceutical ingredients, diagnostics, pharmaceutical products, and medical devices.

For Economic Co-operation and Development (OECD) used for establishing non-hazardous nature of company products GLP has become an important criterion to be followed by the organizations. GLP system has been evolved to perform planned laboratory studies, check performance, monitor records and reports. GLP practices are intended to promote the quality and validity of test data.

GCP is an international quality standard that is provided by International Conference on Harmonization (ICH). It also provides assurance of the safety and efficacy of the newly developed compounds. Good Clinical Practice Guidelines include standards on how clinical trials should be conducted; define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors.

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