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

Client

PT Otto
PT Mahakam Beta Farma
PT Meprofarm
PT Dankos Farma
PT Guardian Pharmatama
Lucas Djaja