‣ apparatus provides the in vitro corelation for successful formulations in comparison to referencelisted products . The use of different detectors , like refractive index detectors , fluroscence detectors , evoporative light scattering detector and QDa detectors , during method development ensure product safety and efficacy , which in turn helps to provide substantial data for regulatory authorities . In addition , orthogonal analytical techniques help to better understand the product composition in terms of compliance towards Q1 ( qualitatively ) and Q2 ( quantitatively ).
Considerations during testing
It is important to use formulation development and manufacturing knowledge when determining analytical and QC testing methods . Various points should be considered during method selection . Methods should be stable and sensitive enough to successfully detect and quantitate as per current regulations . In addition , the development of analytical methods for genotoxic impurities needs to be taken into account , as this will be subject to a critical review by regulatory agencies . Alcohol dose dumping studies must also be considered for extended release dosage forms and stability studies should follow the format as recommended by regulators . In place of three separate HPLC methods , a single method has been developed with the required predetermined reproducibility and resolution . This saved costs during each stability run . Table 1 shows the results . Validation documents facilitate access into regulatory agencies . In order to speed up time-to-market , it is essential that the documents are completed to a high standard and that you can respond to queries efficiently . To ensure that data is error-free , a strict GMP environment , custom field calculation and the capability for electronic data back-ups are required . QbD method validations enable a full understanding of the vital parameters of the analytical method and allow trouble-free methods throughout the product life cycle .
Final thoughts
A comprehensive understanding of current techniques underpins a successful analytical testing strategy . CDMOs are also paving the way in the development of shorter methods , which is a primary factor driving significant reductions in testing times .
Capacity is also a key challenge when planning an analytical testing programme . As CDMOs have the capacity to support a customer ’ s QC and analytical laboratories , at the necessary scale , this frees up Marketing Authorisation holders to focus their attention on other activities . Even large pharma companies can struggle to have the resource to run large analytical testing programmes , especially when it is beneficial to timelines to perform activities in parallel . CDMOs can add significant value here . Remaining at the forefront of regulatory updates and pharmacopeial changes is also key to developing and validating suitable methods . In summary , an innovative approach to analytical chemistry , paired with knowledge of drug product development and manufacturing , is the best strategy to improve time to market for novel drug products . •
J j
Dr Ramesh Jagadeesan
SNR . DIRECTOR FOR ANALYTICAL DEVELOPMENT
30 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981