Standards

Standards (Primary and Working)Quantity Management and Tracking Software

Standards Management are one of the significant factors for reliably good quality of pharmaceutical products. They are used as primary standards or secondary standards for the quality control of active pharmaceutical ingredients (APIs), excipients and finished pharmaceutical products. AmpleLogic Standards Usage Log allows in managing and tracking of Primary Standards, Impurity Standards, Reference Standards, and working Standards based on vial usage and quantity.

AmpleLogic Standards Management and Tracking Software will be the best fit especially in the QC labs (Quality Control) of Pharmaceutical and Biotech Companies to identify, track the QC Logs and other activities in the laboratory. This Standards Management Software also comply with 21 CFR Part 11, US FDA and EU Annex 11 and helps in adherence to Good Laboratory Practices (GLP)

Standards Management and Tracking Software contains separate modules

  • Reference Standards (Primary)
  • Working Standards
  • Laboratory Standards
  • Reference Solution
  • Impurity Standards

Challenges of Standards Quantity Management

  • Managing the Reference/working standards logs and Secondary Standards using logbooks is quite challenging as it requires manual reconciliation of quantities and Usage.
  • Challenges in keeping track of Expiry dates.
  • Unable to track and ensure whether the equipment logs, production logs, impurity standards logs, reference standards logs, working standards logs and laboratory standards logs are up to date and have been verified and reviewed on time by departmental users
  • Non Availability of reference standard logs in Right time will impact the business
  • These challenges are common for Reference Standards, Working standards, laboratory standards, and Impurity Standards

Primary Standards Management and Tracking Software

A reference standard may be obtained from the USP/NF or other official sources (e.g., CBER, 21 CFR 610.0). It also referred to as the primary standard.  Primary Standards are primarily used in analytical studies namely Assay, Identification tests, Limit tests for related substances, Analytical method validation and system suitability in particular spectroscopic and cinematographic analysis.

The reference standards used in the pharmaceutical and biotech industry are expensive for even milligram range quantities and also sometimes may not be available from standard bodies. The traceability to a national or international standards body is very important.

AmpleLogic Primary Standards Quantity management software helps in managing the quantities efficiently and also alerts in case of shortage in the Quantity.

Reference Standards Quantity Tracker helps in generating the traceability of the Quantity used in the Working Standards too.

Working Standards Management and Tracking Software

A Working Standard is also known as In house or secondary standard that is tested and qualified against the Reference Standard. This Secondary Standard can be used instead of the reference standard.”

Working standards are also high purity grade materials which are quantified in relation to primary standards and put to routine use in laboratories. Generally, the working standards are assigned with a validity date depending on the stability of the material. The Analyst will need to prepare the fresh working standards before the expiring the validity of the available Secondary standard.

Sometimes Working Standards are maintained in monthly vials. One vial for each month and additional vials. The additional Vial can be used when the quantity of the respective month is already consumed. Following Manual process keeping track of the Validity date is challenging.

AmpleLogic Working Standards Management software helps in managing the quantities and also provides the traceability with the Reference standard.

Auto alerts the QC team to make sure the removal of Vials which are crossed validity date. Working Standards Module keeps track of usage and inventory of working standards in the Quality Control laboratory

Laboratory Standards Quantity Management and Tracking Software

Managing the Quantities for the Analytical Standards, Color Standard, Flavored Standards and Primary Standard using the manual recording is quite challenging.

Each standard will be maintained in different Vials and keeping track of Quantity in each Vial maintained at different storage conditions is also Challenging.

AmpleLogic Laboratory Standards Management software helps you in keeping track of Standards Quantity Vial Wise, Auto updates the Available and Consumed Quantities.

Reminders and Escalations on Standards does down below certain defined quantity, Validity date, Retest date, and Expiry Date

Reference Solutions Quantity Management and Tracking Software

Quantity Management of Reference Solutions in the QC labs of Pharmaceutical Industry currently managed thru the manual process.

AmpleLogic software for Reference solutions Quantity helps in managing the Quantities efficiently, helps in tracking the quantity usage and Destruction of the reference solutions

Impurity Quantity Management and Tracking Software

Impurities within the pharmaceutical production unit the unwanted chemicals that remain or stay with the active pharmaceutical ingredients (APIs) or develop throughout formulation, or upon aging of every API and to medicines.

The presence of these impurities even in trace amounts would possibly influence the efficiency and safety of the pharmaceutical product. Identification and quantification of impurities (Impurity Profile) unit presently turning into necessary essential product quality parameter and obtaining a review from restrictive regulatory authorities.

As a result of this, limit and threshold values for impurities unit nominal by pharmacopeias and ICH guidelines. Analysis of impurities in keeping with this set of specifications is obligatory for the pharmaceutical product to unharness for human consumption. Impurity Profile study is very important for market approval for finished dose forms from regulatory authorities.

The identification and quantification of impurity within the pharmaceutical product unit carried by using Certified Impurity Standards of acknowledged or known purity.

Impurities purchased by the pharmaceutical company Company’s milligrams (mg) to kilogram weight unit basis. Managing the quantities of the impurities is difficult or troublesome

AmpleLogic’s Impurity management software package helps in managing the quantities. Impurities information data captured based on the present lot or previous lot Grades like JP, BSP, BPCRS, and Non-pharmacopoeial alongside the validity date

The Impurities are placed within the Vials with correct labeling.

The usage of the Impurities recorded and also the same is available as a report against the impurity batch number range

Common Features for all Modules includes

  • Manage the Vials Wise and Quantity wise
  • Barcoding for each Vial will help in avoiding human errors and easy
  • Auto-generation of Consumed Quantity and Available Quantity based on the usage
  • Chemical usage log will provide controlled data access to users based on their roles 
  • Status update based on expiry date and quantity available. System generated alert notification 45 days prior to the expiry date of Standard.
  • This system helps to track and ensure that the equipment logs, production logs, impurity standards logs, reference standards logs as well as working standards logs and laboratory standards logs are up to date and have been verified and reviewed/approved on time by users
  • Usage of vials containing the standard is in sequential order to optimize usage and regular update of available quantity based on individual vial quantities.
  • This system standards usage log will differentiate the vials to active, inactive, and close vials. Only active vials will be available for booking.
  • The Standards usage log will restrict the number of bookings of the same standard at the same time. No two bookings can be allowed for the same Standard at the same time for the same product.
  • 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 the total quantity used for Standard Quantity Usage tracking.
  • Expired standards are not displayed for booking.
  • Enforce the steps for log recording, reviewing and verifying equipment logs as per the approved SOPs and standards
  • Auto Generation of Analytical Standard Destruction Report along with Date of Destruction
  • The entered details or QC logs can be reviewed and approved through approval workflows

Benefits of Standards Quantity Management and Tracking Software

  • Each product/material is assigned with a unique number so that it cannot be replicated and also makes it easy for verification and confirmation.
  • Barcoding Feature helps in easily tracking the standard and able to print various QC log reports of various activities in Quality Control Lab
  • 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 use of the expired material. Thus, reducing the cost and minimizing human errors.
Standards Management
Standards Management – Status Wise Standards
Standards Management
Standards Management – Department Wise Standards Status
 
Standards Management  - Department Wise Standards Status
Standards Management – Types of Standards