It is Drug substance or any other Chemical in the pharmaceutical industry is called as working standard or secondary standard or a working reference standard, refers to a reference material that is calibrated against a primary reference standard and is used for routine analytical testing, quality control, and method validation within a laboratory or manufacturing facility. Working standards serve as practical tools for ensuring accuracy and consistency in day-to-day operations.
Key points about working standards in the pharmaceutical context:
Calibrated Against Primary Standards: Working standards are calibrated using primary reference standards, which are the highest level of reference standards with the utmost accuracy. The primary reference standard's well-defined properties serve as the basis for establishing the accuracy and reliability of the working standard.
Routine Quality Control: Working standards are utilized for routine quality control purposes within a laboratory or manufacturing setting. They are used to calibrate instruments, verify the accuracy of measurement methods, and ensure the consistency of results over time.
Method Validation: Working standards play a key role in method validation efforts. When a laboratory develops or modifies an analytical method, the working standard serves as a reference material for validating the accuracy, precision, and reliability of the method.
Stability and Traceability: Like primary standards, working standards undergo stability testing and are traceable back to internationally recognized measurement standards. This ensures that the accuracy and consistency of the standards are maintained over time.
Inter laboratory Comparisons: Working standards help achieve consistent measurements across different laboratories. By using the same working standard, laboratories can ensure that their results are comparable and standardized.
Backup and Replacement: Working standards can serve as backup standards in case primary standards become unavailable or require recalibration. They offer a level of practicality and flexibility in maintaining measurement accuracy.
Cost-Effectiveness: While working standards are not as rigorously controlled as primary standards, they are accurate enough for most routine testing purposes. This balance between accuracy and practicality makes them cost-effective tools for daily use.
Establishing Specifications: Working standards are used to help establish specifications for pharmaceutical products. By testing products against working standards, manufacturers can determine if the products meet the required quality standards.
In summary, working standards in the pharmaceutical industry are calibrated against primary standards and are used for routine quality control, method validation, and maintaining accuracy in analytical testing. They bridge the gap between the high accuracy of primary reference standards and the practical needs of laboratories and manufacturing facilities engaged in day-to-day operations.
