Standards are one of the significant factors for reliably good quality of pharmaceutical products. They are used as primary or secondary standards for the quality control of active pharmaceutical ingredients (APIs), excipients and finished pharmaceutical products.
Standard material being very highly priced, challenges such as quantity management, missing information and unspecified impurities makes manual handling of standards difficult hence there is a need to automate the Standards Handling process for which AmpleLogic comes to rescue with Standards Quantity Management and Tracking Software.
- Difficulty in maintaining the records of entry and exit of the material/product.
- Lack of tracking the availability of quantity sometimes leads to shortage of Standard for testing.
- Constant verification on expiry date of the product/material.
- Always danger of material wastage.
AmpleLogic Standards Management and Tracking Software comply with 21 CFR Part 11 and other Specifications documents within business areas regulated by the FDA and follows the GMP (Good Manufacturing Practices) and GLP (Good Laboratory Practices) rules.
AmpleLogic Standards Quantity Management and Tracking Software Features:
AmpleLogic Standards Management software allows managing and tracking of the Primary Standards and working Standards with the following field level details.
- Name of the standard.
- Batch number / Lot number
- Pharmacopoeias status.
- Storage condition.
- Reference Standard Used.
- Date and time of standard entry.
- Quantity of standard used for analysis.
- Analyst Name
- Batch number product analysed using this standard.
Our features also include:
- Status update based on expiry date and quantity available. System generated alert notification 45 days prior to expiry date of Standard.
- Usage of vials containing the standard is in sequential order to optimize usage and regular update of available quantity based on individual vial quantities.
- System differentiates the vials to active, inactive, and close vials. Only active vials will be available for booking.
- System restricts the number of bookings of same standard at the same time. No two bookings can be allowed for the same Standard.
- Making up the validity up to date as expiry date provided in website review grid and displaying alerts on the same base.
- The sum of individual quantities used for booking shall be equal to total quantity used for Standard Quantity Usage tracking.
- Expired standards are not displayed for booking.
- Each product/material is assigned with unique number so that it cannot be replicated and also makes it easy for verification and confirmation.
- The software provides the reports based on the analyst, batch number, and reference standard to working standard linkage.
- The label given to vials gives the review of the necessary information.
- Helps to avoid the unintended usage of the expired material. Thus, reducing the cost and minimising human errors.