PHARMACEUTICALS
Dr Vivek Kumar
BIOPHARMA MARKET DEVELOPMENT MANAGER
Consistent cGMP standards by raw material suppliers enable pharmaceutical manufacturers to achieve higher product manufacturing quality .
SPECTRUM CHEMICAL MFG . CORP . k + 1 732 214 1300 x 4655 J vkumar @ spectrumchemical . com j www . spectrumchemical . com manufacturing , and constitute compliance and quality challenges for pharmaceutical companies .
To mitigate these variations , pharmaceutical manufacturers can ally with a global partner who knows the lay of the land , a supplier with experience and knowledge of international quality standards and the global supply chain , who can provide global network advantages to deal with compliance variations worldwide .
No compromise with quality
The emphasis on quality in pharmaceutical manufacturing is not only due to regulations but is paramount because the quality and purity of drugs protect patients , who rely on the medicines they are prescribed to be both safe and effective . It also protects manufacturers from costly financial losses , failures , recalls and damage to reputation and credibility .
For example , pharmaceutical companies must choose very carefully when selecting a raw materials supplier . The supplier needs to provide testing , validation and documentation with the materials . The raw materials must be of the highest quality , purity and potency . This not only provides a likely greater degree of success in R & D , it can shorten the time it takes to bring a drug to market .
Using the same , standardised raw materials used in R & D during the development process and the production process can accelerate time to market . Thus , manufacturers are mitigating risk throughout both the development and the production process , and ensuring quality with the same materials that are standardised , thus eliminating variation . This speeds time-to-market by eliminating the need to validate certain raw materials all over again .
Conclusion
Pharma and biopharma companies face many challenges in moving drug products through discovery and development to market . In meeting these challenges solutions that can facilitate faster time to market include ensuring regulatory compliance and quality at every stage at each of their manufacturing locations , consolidating process improvements , and selecting a drug development services partner that can provide expertise and customisation to accelerate pharmaceutical production . ●
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