Standards Management

QC Primary, Secondary Reference Standards Tracking Software for for Biotech and Life Sciences

Standards Management plays an important role in manufacturing quality pharmaceutical products. They are used as primary standards or secondary standards for the quality control Laboratory of active pharmaceutical ingredients (APIs), excipients as well as finished products manufactured by pharmaceutical companies. AmpleLogic Standards Usage Log enables the managing and tracking of standards in an organization. These include the 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 establishments. The software can support the tracking and identification of QC logs along with other crucial activities in the labs. This Standards Management Software complies with 21 CFR Part 11, US FDA and EU Annex 11 and helps in adherence to Good Laboratory Practices (GLP)

Different Modules of Standards Management and Tracking Software 

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

Challenges of Primary Standards & Reference Standards Tracking in Pharmaceutical QC Laboratories

  • Managing the Reference/working standards and secondary standards requires time and effort when the procedure involves 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 or primary standards logs, working standards or secondary standard logs, as well as laboratory standards logs are up to date and have been verified and reviewed on time by departmental users
  • Non-Availability of reference standard logs when they are required, will impact the business
  • These challenges are common for Reference Standards, Working standards, laboratory standards, and Impurity Standards

Secondary and Reference Standards Management and Tracking Software for QC Labs

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

The reference standards used in the pharmaceutical and biotech industry are expensive. In some cases they 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 users in case of shortage in the Quantity.

Reference Standards Quantity Tracker supports the organizations ability to trace the Quantity used in the Working Standards too.

Working Standards Management and Tracking Software for Life Sciences

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 typically high-purity grade materials. These standards 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 must prepare fresh working standards before the expiration of the available Secondary standard.

Sometimes Working Standards are maintained in monthly vials. There are additional vials which are utilized when the quantity of the respective month is already consumed. If an organization uses Manual process, keeping track of the Validity date is challenging.

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

Auto alerts the quality team to discard expired vials. The Working Standards Module in the software tracks the usage and inventory of the working standards in the Quality Control laboratory

Laboratory Standards Quantity Management & Tracking Software for Biotech & QC Labs

Managing the Quantities as per the analytical standards and other crucial standards like color, flavors and primary Standard using manual recording is quite challenging.

Each standard is maintained in different Vials. Keeping track of the 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 according to the vials available in a standard. It automatically updates information regarding vials which have been consumed and those that are available.

Reminders and Escalations on Standards when the quantity of standards are lower than a pre-defined level. Escalations and reminders are also in place for validity date, retest date and expiration date.

Reference Solutions Quantity Management and Tracking Software for Quality Control Labs

Quantity Management of Reference Solutions in the QC labs for companies that currently use manual processes.

AmpleLogic software for Reference solutions Quantity helps in managing the quantities of standards in an efficient way which allows for easy tracking of the usage of the standards and the destruction of reference solutions when required.

Impurity Quantity Management and Tracking Software for Pharmaceuticals

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

Impurities, even in the smallest of amounts can impact the efficiency and safety of the product. This is the reason why regulatory authorities require strict adherence to reference standards. It ensures that pharmaceutical product meets the quality parameters and receives approval from regulatory authorities.

Consequently, ICH guidelines and pharmacopoeias identify a limit for impurities providing companies with a threshold value that they must comply with. The impurities must be analysed with these values in mind so that the pharmaceutical product is effective and safe for human consumption. Without an impurity profile study, a product may not receive market approval by the regulatory authorities for finished dose forms.

The identification and quantification of impurity within the pharmaceutical product unit is completed by following the guidelines for Certified Impurity Standards of acknowledged or known purity.

Impurities purchased by pharmaceutical company must be identified in milligrams to kilograms weight. For companies, it may be difficult or troublesome to effectively manage the quantities of impurities.

AmpleLogic Impurity management software package helps organizations effectively manage the quantities. It captures crucial information related to impurities. This information is based on the current lot or on previous lot grades such as JP, BSP, BPCRS. This information is available along with the validity date.

The Impurities are placed within the Vials with correct labeling.

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

Standards Features for all Modules

  • Manage the standards Vials Wise and Quantity wise
  • Barcoding for each Vial will help in avoiding human errors
  • 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 of the vials and the quantity of standards available in the lab. An automated alert is sent to the users 45 days before the expiry date of Standard.
  • This system helps to track and ensure that the equipment logs and other important logs like production and impurity logs along with reference standards logs, 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 are kept and consumed in sequential order. This supports easy tracking of the consumed and available vials through the software.
  • This system standards usage log will differentiate the vials by identifying them as active, inactive and closed. The system will allows users to book active vials only.
  • The standards usage log in the software prevents users from booking 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.
  • Identifying the validity up to date as expiry date provided in the website review grid and displaying alerts on the same basis.
  • The sum of individual quantities used for booking shall be equal to the total quantity used for Standard Quantity Usage tracking.
  • The system does not display expired standards to avoid them from being booked by users.
  • It helps you enforce the procedures that must be followed for log recording, reviewing and verifying the logs as per the approved SOPs and standards
  • The software program is designed to automatically generate an Analytical Standards Destruction Report which includes the date of destruction of expired vials.
  • All entries in the QC logs are available for review and approval through approval workflows

Benefits of Quality Control 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