Importance of Analytical Testing Laboratory

The analytical testing laboratory plays an important role in the pharmaceutical industry to provide information about the procedure and processes to certify that the results are accurate, consistent, and within the given specified limits for the given pharmaceutical products, drug substances, intermediates, raw materials, pharmaceutical impurities, etc.

Analytical testing in the laboratory involves the advanced testing ability to have services like method development, validation, stability studies, detailed analysis and testing of drug products, drug substances, intermediates, raw materials, impurity profiling, etc.

Today analytical testing is dominated by modern and sophisticated instruments for analysis and analytical investigation and needs to comply with 21 CFR part 11 standards. Analytical provides information about the product quality and purity as per the industry norms and this helps the Pharmaceuticals and Healthcare industry to obtain the required certification.

Analytical testing laboratory

The analytical testing laboratory is responsible for developing and validating the analytical methods that should be precise, accurate, reliable, and suitable for testing. The main purpose of the analytical department is to develop robust methods that should be reproducible. Analytical methods are considered to establish the purity, identity, and physical characteristics of the drugs during various process testing.

In the analytical laboratory, the systems are in strict compliance with Good Laboratory Practice (GLP) with international and national requirements. Quality control starts with the collection of samples till the reporting of the data.

The foremost control is the complete system of the laboratory like the specification of instruments, reagents, solvents gases, etc., also the documentation of the daily performance, and checks should be done to ensure that data is correct and accurate.

Further regular interval investigation is to be done for calibration standards, references, and control check samples to prove the reproducibility of the data. These routine quality checks ensure the control of quality.

The pharmaceutical industry’s importance of analytical laboratories and instruments is constantly increasing as the number of compounds for investigation continues to increase. The Analytical scientist needs to work on every project and develop new methods as per the customer’s requirements and this leads to the development of new analytical testing methods.

The analytical team should be able to demonstrate that the analytical methods are suitable for the required separation, simplicity, and precision for the required compound and can be easily adapted. There is an increasing demand for analytical testing laboratories services across the industry from pharmaceutical, biotech, environment, and other industries.

To improve the accuracy, reliability, and efficiency of drug testing there is the requirement of qualitative and quantitative analysis to check the quality of the final product and also to ensure that raw material meets the required specification the characterization and isolation of impurities is compulsory for acquiring and evaluating data which discloses the need and scope to perform impurity profiling. Nowadays various analytical techniques are used to isolate and quantify the impurities.  

In the pharmaceutical industry, the future of analytical testing has a significant role with new analytical methods, improvement in technology, and data analytics that will increase the precision and speed of the testing process and lessen the time required for results.

FAQs

What is Analytical testing in the pharmaceutical Industry?

Analytical testing is to develop analytical methods that should be precise, accurate, reliable, and suitable for testing. The main purpose of the analytical testing is to develop robust methods that should be reproducible.

What is the purpose of Analytical testing in the pharmaceutical Industry?

Analytical testing involves the advanced testing ability to have analytical services like method development, validation, stability studies, detailed analysis, and testing of drug products, drug substances, intermediates, raw materials, impurity profiling, etc.

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