FAQ

What is level of certification?

The facilities operate in accordance with "cGMP" (current good manufacturing practice) and are certified by all FDA equivalent local authorities in destinations where finished products are exported. All our operations are subject to quality audits by our clients at least once a year. In addition, Interphil Laboratories, Inc. is certified by the Australian TGA. 

What is the minimum manufacturing volume?

Dry products 200,000 tablets

Capsules 200,000 capsules

Liquids 1,000 liters

Cream & ointment 100 Kgs

Penicillin / Cephalosporin 200,000 capsules

Penicillin / Cephalosporin 200,000 tablets

Powder for Suspension 150 Kgs

 

Note: Start-up costs are incurred to cover stability, validation pilot batch procedures.

What information is made available to clients?

Batch status report

Service level

Batch record

Materials Inventory

Annual Product Review

QA Deviation Report

Customer Feedback

QA Change Notification Summary Report

QA Analytical Report

QA Certificate of Analysis

QA Stability Tabulation

QA Certificate of GMP Compliance

 

Note: Some of the reports are issued upon client’s request.

How long does it take to change a manufacturing site?

 < 6 months Australia, New Zealand, Singapore 

6-12 months Malaysia, Hong Kong, Vietnam

12-24 months Philippines, Thailand, Taiwan

Which countries are currently supplied by Interphil Laboratories, Inc.?

Taiwan

Hong Kong

Thailand

Vietnam

Malaysia

Singapore

Philippines

Australia

New Zealand

Africa

Saudi Arabia

Kazakhstan