The Chemistry, manufacturing, and control (CMC) testing of drug substances and drug products play a critical role guaranteeing the quality of the drug product entering clinical trials. Subsequently, the validated methods and technologies are transferred to Quality Control (QC) in commercial manufacturing.
All ingredients including the methods used during the manufacturing process must be included in the CMC section of both the Investigational New Drug (IND), New Drug Application (NDA), and Abbreviated New Drug Application (ANDA) dossiers. The documents must show the acceptable limits and analytical methods used to assure the identity, strength, quality, and purity of the drug substance and drug product including enough information to support stability. Additional information is required for the drug product such as packaging procedures.
PerkinElmer enables Pharma partners in rapidly developing and commercializing new small and large molecular entities across various therapeutic areas via innovative technology solutions and services, paving the way to support CMC compliance by providing:
Production comes to a halt when impurities are identified above the threshold level and the drug substance must be re-evaluated, increasing cost of production and time to market.
Drug substance is the active pharmacological ingredient used in a finished pharmaceutical product and has a direct effect on both the treatment and prevention of disease. To ensure the purity, quality and safety of a drug substance, it is essential to perform analytical tests to identify if any impurities or adulterants exist.
Our advance analytical tools provide the data to mitigate compliance risk and guide your GMP standards compliance for the identification of incoming raw material testing, drug substance assay and excipient quality.
The suitability of drug substance for its intended use is defined by attributes such as identity, strength, and purity – which can be achieved by using instruments, consumables and services you can find from PerkinElmer.
Drug product or finished dosage form (tablet, capsule, injectables) contain a drug substance (API) and excipients. All drug products must be GMP compliant to be released for commercial use.
The suitability of a drug product for its intended use is defined by attributes such as the identity, strength, and purity – which can be achieved by using instruments, consumables and services you can find from PerkinElmer.
Our analytical instrumentation, microfluidics technology, informatics solutions, and service and support, provide pharmaceutical manufacturers confidence in the quality of their product and compliance in their process from beginning to end.
Regulatory bodies, such as the EMA and FDA, provide increasingly stringent guidelines around impurity limits, control of those impurities becomes exponentially critical during CMC testing. Implementing testing to control impurities is crucial on your path to compliance.
PerkinElmer provides the tools and processes you need to take control of impurities testing for both drug substances and drug products – providing the best technology for the identification and quantification of elemental impurities and the accurate measurement of residual solvents in accordance with strict regulatory guidelines.
The suitability of either a drug substance or drug product for its intended use is defined by attributes such as the identity, strength, and purity – which can be achieved by using instruments, consumables and services you can find from PerkinElmer.