ADVERTORIAL
QC for biopharma :
Change control , compliance & collaboration
Biopharmaceuticals require some of the most stringent quality control protocols . Produced from living cells using cutting-edge biotechnology with exacting standards , any compromise in material or deviation in process could mean a significant financial loss , drug shortage and / or potential adverse patient outcomes . As biopharmaceutical manufacturers evaluate alternative suppliers due to global supply chain disruptions , close collaboration between the manufacturer and supplier is critical to meet market requirements , minimise risk and ensure quality control .
Change control & consistency
Because the production of biopharmaceuticals such as vaccines , antibodies and recombinant proteins requires more stringently controlled processes and raw materials compared with traditional small molecule drugs , change control is particularly important . This ensures that no unnecessary changes are made and , if they are , they are thoroughly documented and communicated . “ Any unintended deviation can have a significant impact on a drug ’ s performance ,” explains Jigisha
Patel , VP of Quality and Regulatory Compliance for Spectrum Chemical . “ That ’ s why manufacturers should partner with suppliers that have adopted strict , fully functional quality management systems that help ensure change control and materials meet specifications and process needs with validated consistency .” Patel points to Spectrum Chemical ’ s QC protocols , which encompass multiple processes , including change control and batch traceability , monograph compliance , lab testing certifications , scientific documentation , and packaging and labelling . Certifying that raw materials are free of contaminants or foreign particles is critical to bioprocessing . Another example involves current good manufacturing practices ( cGMP ). Suppliers may differ in their application of GMPs and audit programmes can be difficult to develop and implement . Biopharmaceutical manufacturers should ensure that suppliers of raw materials can provide complete GMP audit reports , including documentation of non-compliance events , and corrective and preventive actions ( CAPAs ).
100 % tested . 100 % transparent . 100 % trusted .
Spectrum Chemical ’ s industry-leading bioCERTIFIED™ quality management system and chemicals are intended to help biopharmaceutical manufacturers deliver products with remarkable consistency quickly and efficiently . With more than 50 years of expertise as a supplier to drug developers , Spectrum Chemical knows how to address current issues and challenges while facilitating faster processes and higher quality . For example , each bioCERTIFIED chemical undergoes complete testing including expanded analysis for bioburden , endotoxin and residual solvents to ensure it meets monograph requirements . Additional testing is also available to meet manufacturer specifications .
Collaborative confidence
Spectrum Chemical ’ s bioCERTIFIED programme also provides complete traceability , including change control and batch tracing , a dossier of regulatory and scientific information , auditing and quality management . All products are packaged in ISO Class 8 cleanrooms with very specific protocols . In addition to bioCERTIFIED materials , customers gain a best-inclass support team , robust scientific documentation , and strict quality and certification processes to ensure product consistency , predictability and performance . “ We can serve as an adjunct to the manufacturer ’ s own QC team , providing supply chain transparency , standardised materials and confirmatory testing ,” says Patel . “ Our collaboration definitely brings confidence and peace of mind while helping speed final product to market .” •
For more information , visit SpectrumChemical . com / biocertified
60 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981