Use Case
About Client:
A global pharmaceutical company operating in regulated and emerging markets with an exhaustive pipeline of branded generics, generics and OTC products across various formats and dosage formulations. The company markets its products in 100+ countries and is backed by its own R&D and manufacturing facilities across Europe, Africa and Asia Pacific markets. .
Hassle
Sample stock pick up is manually driven with no segregation of stock by sampling activity.
Laboratory Test Request Form (TRF), creation (paper) and issuance (email) are an administrative task .
Lack of traceability of pharmaceutical finished batch and its quality inspection status post goods receipt .
Batch quality documents (checklist review and release documents) maintained on paper – prone to loss, data integrity and compliance issues
Edge Out with PharmaNET Batch Release Software
- Sampling quantity is based on sampling plan and there is clear segregation and storage of sample quantity by sample category: Chemical, Micro, QP, Stability, Retention, etc.
- Automatic generation and email issuances of TRFs.
- Batch checklist (QA/QP) templates as per your SOPs configured on to the system with data feed complying to 21 CFR Part 11 and Annex 11 guidelines for electronic records.
- Anytime, Anywhere controlled electronic batch release even when batch release activity is outsourced.
- Complete visibility and traceability, finger on the pulse for each batch.
- Measure lead times effectively b/w each stage: GRN, Sampling, TRF, COA Upload, Batch Review & Release and amplify operational efficiencies.
