Secondary and Reference Standards Management and Tracking System for QC Labs
The USP/NF or other government agencies like CBER, 21 CFR 610.0 are good sources of a reference standard. Primary Standards are typically employed in analytical investigations such as assays, identification tests, and limit tests for closely related chemicals. They are also used to validate analytical methods and to determine the appropriateness of systems for specific spectroscopic and cinematographic analyses.
It is costly to adopt pharmaceutical and biotech industry reference standards. In certain situations, conventional organizations may not have them. The ability to track back to a national or international standards organization is critical.
AmpleLogic Primary Standards Quantity Management Software enables effective quantity management and also informs users in the event of a quantity shortfall.
Reference Standards Quantity Tracker aids organizations in monitoring the number of materials (quantity) used in the production of the working standards.
Working Standards Management and Tracking Software for Life Sciences
A Working Standard sometimes referred to as an in-house or secondary standard, is one that has been assessed and validated against the Reference Standard. This Secondary Standard is interchangeable with the reference standard.
High-purity grade materials are commonly used as working standards. In laboratories, these standards are routinely used and measured based on the primary standards. Working standards are often allocated a validity date based on the material’s long-term stability. As soon as the current Secondary standard has expired, the Analyst must come up with new standards.
Monthly vials are used to keep track of Working Standards. When the quantity for a certain month has been used, further vials are used. Keeping track of the Validity date might be difficult if an organization employs a manual method.
In addition to providing traceability, the AmpleLogic Working Standards Management program helps manage numbers.
The quality team is automatically notified to dispose of expired. In the Quality Control laboratory, the Working Standards Module records utilization and inventory of the working standards.
Laboratory Standards Quantity Management & Tracking System for Biotech
Using manual recording to manage quantities following analytical standards and other important standards such as color and flavour is difficult.
Each standard is kept in a separate Vial. Keeping track of the quantity contained in each vial under various storage conditions is similarly difficult.
AmpleLogic Laboratory Standards Management software enables you to keep track of the number (quantity) of Standards based on the number of vials included in a standard. It automatically refreshes the information on consumed and available vials.
Reminders and Escalations on Standards are sent when the quantity of standards falls below a predefined threshold. There are additional escalation and reminder systems in place for the validity date, retest date, and expiration date.
Reference Solutions Quantity Management and Tracking Software for Quality Control Labs
Quantity Management of Reference Solutions in QC Labs for Companies Using Manual Processes.
AmpleLogic software for reference solutions quantity aids in the proper management of standard quantities, making it possible to trace the use of the standards and eliminate reference solutions as needed without difficulty.
Impurity Quantity Management and Tracking Software for Pharmaceuticals
During the pharmaceutical manufacturing process, impurities can arise when undesired chemicals remain in the active pharmaceutical ingredients (APIs) or develop during the formulation process.
Impurities, even in small quantities, can have a detrimental effect on the product’s efficacy and safety. This is why regulatory agencies impose stringent requirements on the use of reference standards. It guarantees that pharmaceutical products satisfy quality standards and get regulatory clearance.
As a result, ICH recommendations and pharmacopeias define an impurity limit, which manufacturers must adhere to. Impurities must be analyzed following these standards to ensure that the pharmaceutical product is both effective and safe for human consumption. Without an impurity profile analysis, regulatory agencies may deny market clearance for final dosage forms.
The standards for Certified Impurity Standards of recognized or known purity are followed to identify and quantify impurities within the pharmaceutical product unit.
Impurities bought by a pharmaceutical firm must be measured in milligrams to kilograms. It may be difficult or time-consuming for companies to efficiently manage the amounts of contaminants.
AmpleLogic’s impurity management software solution enables companies to control quantities appropriately. It records critical information about impurities. This data is based on the current lot or prior lot grades such as JP, BSP, and BPCRS. This information is accessible, as is the date of validity.
The impurities are correctly labelled and put into the Vials. The impurity batch number range is tracked and the use of the impurities is presented as a report.