Toll Manufacturing
Toll Manufacturing
Quality standards
- cGMP Compliance Class-A
- ISO 9001 : 2000 (since 1999)
- ISO 14001
- ISO 18001
- SMK3
Contract Manufacturing Receiving System
- Buying Product System
- Receiving toll in request
- Filling toll in application
- Investigation by engineering team
- Quality audit by customer
- Commercial Investigation
- Submitting Registration Document
- Starting production following the issuance of Registration Number
- Toll Product System
- Receiving toll in request
- Filling toll in application
- Investigation by engineering team
- Quality audit by customer
- Commercial Investigation
- Product Trial
- Submitting document for production terms: master of batch record, product specification, material specification, method analysis, etc
- Starting production following the issuance of Registration Number
Plant Location
- Semarang City - Central Java
Production Facilities
- Non Betalactam
- Tablet
- Coated Tablet
- Capsule
- Ampoule Injection
- Vial Injection
- Cream
- Syrup ( Sachet dan Bottle)
- Powder (Sachet dan Bottle)
- Betalactam
- Tablet
- Capsule
- Vial Injection
- Dry Syrup
Sterile Facility Overview
- Located at 3rd Floor within the Production Plant
- Facility Standards consist of :
- Sterile rooms and clean equipment for production
- Purified Water, Water for Injection, and Clean Steam System
- Chemical and Microbial analysis Laboratory
- Temperature Controlled Warehouse
- External Infrastructures, Wastewater Treatment Facility and Cafeteria
- Fill - Finish Operations
- Aseptically filled into vials or ampoules
- Terminal Sterilisation if needed
- Dedicated HVAC for White / Sterile Area
- Terminal HEPA Filters for every Aseptic Processing Machine
Selengkapnya di : http://bit.ly/TollManufacturingPhapros
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