Analytical Method Development

Analytical Method Development What are the capabilities of ITL Labs in method development ? ITL Labs has the trained expertise and all the state-of-the-art-facilities required for developing new methods of analysis for all kinds of components in different complex matrices. The methods developed by ITL Labs can be used by other laboratories. The capability of ITL Labs in this area has been acknowledged by the international bodies concerned with the quality standards and systems.  Method Validation / Evaluation Method validation is the process of documenting or proving that : Analytical Method provides analytical data for the intended use   Why is analytical method validation required ? Method Validation is required for the following reasons » Assuring quality and achieving 3 a levels » Achieving acceptance of products by the international agencies. » Mandatory requirement purposes for accreditation as per FDA , ISO 9001 & 17025 guidelines » Mandatory requirement for registration of any pharmaceutical product or Pesticide formulation » Validated methods are only acceptable for undertaking proficiency testing.   What are the various parameters studied for Method Validation ? For validation the developed method is subjected to following studies : » Precision / Reproducibility » Accuracy » Linearity » Specificity / Selectivity » Limit of detection » Limit of quantitation » Robustness / Ruggedness   Analytical Method Development is required for : » Herbal Products » New process and reactions » New molecules » Active ingredients (Macro analysis) » Residues (Microanalysis) » Impurity Profiling » Component of Interest in different matrices   What does analytical methodology consist of ? An Analytical Methodology consists of the following » Techniques » Method » Procedure » Protocol   What does analytical methodology provide to an analyst ? » The required data for a given analytical problem » The required sensitivity » The required accuracy » The required range of analysis » The required precision i.e. the minimum requirements which essentially are the specifications of the method for the intended purpose: To be able to analyse the desired analyte in different matrices with surety and certainity. Training

ITL's  employees consist of a unique blend of seasoned professionals, young, qualified and enthusiastic researchers/analysts and capable support staff. ITL’s employees are its greatest strength and intellectual property. As staff strength is the critical factor for ensuring success, Human Resource Department at ITL aims at enhancing employees' caliber by imparting training, in-house as well as from outside sources. Training programmes are conducted at ITL on a regular basis where faculties are sometimes from within the Institute and also invited professionals from external sources. The Experts of ITL Labs conduct specialised training programmes on behalf of various organisations in different fields of Science and Technology. The scientists also undertake several projects related to social sectors wherein extensive training is provided to the various agencies for the development of rural sectors.

Training Needs

Training needs of the ITL Labs staff are assessed on a continuous basis. The assessment is done at individual as well as organisational level. An annual Training Calendar is prepared at the beginning of the Financial Year, through personal discussion with the Laboratory Incharge, Divisional Head and the Director. The feedback is provided by the Trainee and the Divisional Head reports about the effectiveness of the training.

Induction Training Programmes

Under Induction Training Programmes, all the new employees in the Institute are provided training. Every new employee is put under a senior colleague capable of providing support, advice and help to provide certain basic inputs that would help him/her in functioning effectively. Orientation programmes are also carried out for new employees.

Specialised Instrumentation

Depending upon aptitude, employees are also imparted training on operating the sophisticated instruments like FTIR, GC, HPLC, GCMS , ICP,AAS etc.

External Training

From time to time ITL Labs sends employees to attend specialised courses/workshops to attain proficiency in their respective fields. The employees are also encouraged to attend seminars/conferences etc to update their knowledge.

Practical Training To Students From Academic Institutions

ITL Labs  has memorandum of understanding signed with various Universities and Institutes of Technology in the country for exchange of research programmes and joint research projects. ITL is associated with various academic Institutions all over India for providing training facilities to their graduate and post graduate students. The students are required to complete a project and prepare a report as part of the practical training/project, which is an integral part of their curriculum.