China Pharmaceutical Track & Trace
All-in-one solution based on unique code for each item for China pharmaceutical Track & Trace compliance
China's NMPA (was CFDA) and pharmaceutical manufactures have dedicating on improve medical safety together for decades. Providing more academic statistics for end user's decision making and upgrading supervision from prodction to end user receiving, which are two common methods that pharmaceutical companies choose to use from product itself and during transportation. Anti-counterfeiting and anti-channeling are two key targets to keep physical secure of pharmaceutical on production and transportation, Track & Trace solution/solution based on unique code for each item is the way of implement China pharmaceutical regulation compliance. Combined JawaSoft's Track & Trace and Product Tracing System (PTS) is the advanced solution for China pharmaceutical regulation compliance in one production line for multi-dose, multi-form of product on packaging. JawaSoft can provide all-in-one service in production which against lifescience threating; the production line upgrading or customized will improve competitiveness from brand reputation, production efficiency, future expansion and implement informatization under big data era.
Compliance - CHINA PHARMACEUTICAL REGULATION
According to national guideline about Food and Drug Administration and Ministry of Agriculture and Rural Affairs of the People's Republic of China, the product for public all required to realize unique code for each item by adopting information technology and automatic identification technology. To sum up, China pharmaceutical Track & Trace project include human use medicine, veterinary medicine, and agricultural medicine. Based on different industry, Track & Trace solution will have some difference.
The trend of regulation is use unique code for each item (smallest sales unit) to realize medical full lifecycle Track & Trace:
• For regulatory authorities, provide a set of informatization technology method to build full lifecycle product traceability system;
• For enterprise, realize anti-counterfeiting, anti-channeling warnings, and recall for unqualified products.
During the development of Track & Trace implementation in China, there are some difficulties for pharmaceutical companies:
• Different industry with different Track & Trace standard/requirement:
Human used medicine traceability: no uniform standard;
Veterinary Drug traceability: national standard;
Pesticide traceability: semi-open unified standard, which leaves a certain flexible space for enterprises to customize the product code;
• Different industry with different investment trend.
Track & Trace project in China pharmaceutical regulation compliance
• Under the conditions of high volum of production, it is difficult to control the quality and safety of medical product for traditional pharmaceutical company;
• Driven by interests, the large demand for medicines makes it impossible for medicines from many supply channels to verify their authenticity and ensure their safety;
• Driven by interests, the price difference of medicines in various regions makes the drug diversion deviation from plan seriously, cause inability to supply medicines to required regions in a reasonable price and timely manner;
• When pharmaceutical companies produce multiple varieties, multiple dosage forms, and multiple categories of products, it is difficult to effectively manage storage.
PTS - YOUR ENTERPRISE MEDICAL INFORMATION MANAGER
PTS is a solution for develop business value based on medicine information interaction.
JawaSoft patented software PTS could manage huge amount of data in easy way and assist on market decision making. PTS could docking with Drug regulatory authorities, enterprise system (e.g. ERP, WMS), and production line (include coding unit, camera, labeller, etc.) with user friendly interface. Supporting all types of coding method, type, item's interface and aggregation is one more reason for improve production efficience.
Coding & Aggregation - YOUR MEDICINE QUALITY SAFEGUARD
Coding & Aggregation software is a solution for anti-counterfeiting on each sales unit.
China pharmaceutical regulation compliance is aim to avoid counterfeiter enter the market and caused life threatening happends. Authorized institution require unique code and aggregation for each smallest sales unit to be traceable from manufacture to end user as regulation required.
Unique code (e.g. Data Matrix, QR Code) on each smallest sales unit is machine readable and it is unique in China to be traceable, alarm, and recall. Aggregation is assign relationships between packaging levels (carton/bottle/vial/bag, bundle, box, pallet), which between lower packaging level and higher level or through several packaging levels to ensure each item is tracable and the record about product can be traced for years.
Track & Trace - YOUR PRODUCT LOCATION TRACKER
Track & Trace is a solution for (at least) lot-level of product traceability and anti-channeling.
The lower level packaging (e.g. carton/bottle/vial/bag) is coding and inspect under high speed to qualify traceability requirement and high volume production requirement. For any type of complicated production line, JawaSoft can provide efficient solution on coding and inspection line of code inkjet printing, inspection, labeling, sealing whether semi-automatically or automatically under ISO standard.
WMS - YOUR WAREHOUSE MANAGER WITH NO MISTAKE
Warehouse Management System (WMS) is a solution for product inbound and outbound management in warehouse.
Optimizing product management by machine readable unique code on each unit of store package in warehouse. User friendly interface could docking with other systems (e.g. transport system), and support inventory product visualization in all types of warehouse with semi-automatic operation or fully automated operation.
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