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Standards Management

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Standards Management Software

Standards management is critical in the manufacture of high-quality pharmaceutical goods. They are employed as primary or secondary standards in pharmaceutical firms’ quality control laboratories for active pharmaceutical ingredients (APIs), excipients, and finished products. AmpleLogic Standards Usage Log helps a company to manage and track its standards. These include main standards, impurity standards, reference standards, and working standards.

AmpleLogic’s Standards Management and Tracking Software are ideal for pharmaceutical, contract research organization (CRO), contract development and manufacturing organization (CDMO) and biotech companies’ QC (Quality Control) laboratories.  QC logs and other critical lab operations may be tracked and identified with the program. This Good Laboratory Practices (GLP) Compliance Software conforms with 21 CFR Part 11, the US Food and Drug Administration (FDA), and EU Annex 11.

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

  • When manually reconciling quantities and use, managing the reference/working standards and secondary standards is time-consuming and stressful
  • Keeping track of expiration dates is difficult
  • Inability to track and ensure that equipment logs, production logs, impurity standards logs, reference standards or primary standards logs, working standards or secondary standards logs, and laboratory standards logs are current and have been authenticated and evaluated on a timely basis by departmental users
  • Inability to obtain reference standard logs when needed will affect the business
  • Reference Standards, Working Standards, Laboratory Standards, and Impurity Standards all face these difficulties

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.

Standards Features for all Modules

  • Manage standards based on vials and quantity
  • Barcoding each Vial will aid in the prevention of human mistakes
  • Consumed Quantity and Available Quantity are generated automatically based on the use
  • Chemical usage logs will provide users regulated data access depending on their roles
  • Status update depending on the expiration of the vials and the number (amount) of standards in the lab. Users receive an automatic notice 45 days before the expiration date of the standard
  • This system assists in tracking and ensuring that equipment logs and vital records, such as those on production and impurity levels and standard working standards logs, and laboratory standards logs are current and have been checked and approved by users on time
  • The standard vials are maintained and used in successive sequences. This enables efficient tracking of used and available vials through the program
  • This system standards usage log will categorize the vials as active, inactive, or closed. Users will be able to reserve only active vials using the system
  • The software’s standard usage log restricts users from reserving the same standard concurrently. No more than two reservations for the same Standard can be made concurrently for the same product
  • Detecting the most recent validity using the expiry date supplied in the website review grid and showing notifications on that basis
  • The overall amount utilized for Standard Quantity Usage tracking must be equal to the sum of individual quantities used for booking
  • To prevent users from booking expiring standards, the system hides them from view
  • Using it makes it easier to implement the log recording, review, and verification procedures required by authorized SOPs and standards
  • The software generates an Analytical Standards Destruction Report, which contains the date on which expired vials were destroyed, in an automated way
  • All entries in the quality control logs are reviewable and approvable using approval processes

Benefits of Quality Control Standards Management and Tracking Software

  • All products/materials are issued a unique number to ensure that they cannot be duplicated and to facilitate verification and validation
  • Its barcoding function allows for easy tracking of standards and printing of numerous QC log reports of various operations in the Quality Control Lab
  • The analyst, batch number, and reference standard to working standard linkage are all taken into consideration by the program when producing reports
  • The label on the vials provides a summary of the required information
  • It helps in avoiding the unintentional usage of expired material. As a result, costs and human mistakes are reduced
Our On-Premise and Cloud-Based Standard Management Software can also be used in the following fields:
  • Biologics
  • Medical Devices
  • Contract Development and Manufacturing Organization (CDMO)
  • Chemical Industry
  • Contract Manufacturing
  • Generics
  • General Manufacturing
  • Contract Research Organization (CRO)
  • Food & Beverages

Send us an email at info@amplelogic.com if you’d like to see a demonstration of the AmpleLogic Standards Management Solution.

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