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At OriginBio, a comprehensive traceability system is implemented to record and monitor every stage of the product lifecycle, from raw material receiving to manufacturing and final product distribution. This system ensures full transparency, regulatory compliance, and rapid traceability throughout the supply chain.
Upon receipt, raw materials are inspected and verified against supplier qualifications and Certificates of Analysis (COAs).
Each approved material is assigned a unique batch number.
Material information is entered into the traceability system and linked to its batch code.
Raw materials are stored in designated areas with clear batch identification, ensuring one-to-one traceability between physical inventory and records.
Prior to production, approved raw material batches are issued according to the manufacturing schedule.
The production batch number is linked to all raw material batch numbers used in the formulation.
Critical process steps, such as blending, sterilization, cooling, filling, and packaging, are documented and recorded by authorized personnel.
In-process inspections and quality checks are performed before materials proceed to the next manufacturing stage.
Upon successful completion of production and quality testing, each finished product batch is assigned a unique traceability code.
The traceability code is linked to the corresponding production batch.
Product information, batch details, quantities, and test results are recorded in the traceability system.
Traceability codes are printed or applied to product packaging for identification and tracking purposes.
Before shipment, finished product batch numbers and traceability codes are verified.
Distribution records include customer information, shipment quantities, and transportation details.
Complete shipment records are maintained to ensure full product traceability throughout the distribution chain.
Comprehensive Batch Production Records are maintained for every manufacturing lot in accordance with cGMP requirements.
Each Batch Production Record includes:
Product name, specification, and batch number
Production start and completion dates and times
Signatures of production supervisors and operators
Verification signatures for critical operations, such as weighing and dispensing
Raw material batch numbers and actual quantities used
Processing parameters, control limits, and equipment identification numbers
In-process control results and QC verification records
Yield calculations and material reconciliation records
Documentation of deviations, investigations, corrective actions, and approval records
These records provide complete traceability, support quality assurance activities, and ensure compliance with international GMP standards.
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