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