As discussed in previous edition, compliance with compendial requirements is a legal and regulatory requirement. While there is good awareness of compendial requirements for drug products and APIs, there is less understanding by excipient manufacturers related to compliance to pharmacopoeial monograph. Companies that manufacture, distribute and use excipients must meet appropriate quality and regulatory requirements.
Formulators use different excipients for formulating a product. The choice of excipient depends on the type of formulations & the role of excipient in formulation. Excipients can be broadly classified in categories such as functional, multifunctional, co-processed excipients; other than these, formulators also use in formulation. The inorganic salts play crucial role in pharmaceutical product w.r.t. to efficacy & stability. In recent past it’s been observed that the increasing regulatory stringency, cost, time-intensive drug development process and the quality concerns of inorganic excipient’s present a significant challenge to the manufacturers & users.
Considering the challenges faced by the manufactures to source the inorganic salts ThermoFisher has introduced new range of products ‘ExciQ™’ – Pharmacopoeial grade chemicals (complying to various pharmacopoeias such as IP/BP/USP/Ph. Eur.).
At ThermoFisher implementation of Quality Management Standards is a primary objective which differentiate us from other players. Accurate assessment of requirements & proactive approach to implementing quality and regulatory standards is the motto of ThermoFisher. Our goal is to offer customer satisfaction while ensuring complete compliance of all relevant standards.
We have a state-of-the-art manufacturing facility certified by FDA(GMP/Schedule-M) & accredited with ISO 9001:2008 certification. The quality systems are continuously monitored and reviewed by Quality Management, to capture areas for improvement and to plan for sustainable growth.
We manufacture & supply high quality products (salts) which can be sued in manufacturing of pharmaceutical products. These products are also backed by regulatory documentation such as technical package with relevant certification (TSE/BSE, GMO). We also support in QA process such as quality audits, vendor qualification documents and many more.