Toll Manufacturing

Quality standards

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

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