About Us
- Summary information
- Key Personnel
Services
Project
Video
GMP-Handbook
Faqs
News
Jobs
Contact

FAQS

PRODUCTION AND PROCESS CONTROL

List of FAQS

GMP GENERAL QUESTION
FACILITY AND EQUIPMENT
PERSONNEL
MATERIAL
PRODUCTION AND PROCESS CONTROL
HOLDING AND DISTRIBUTION
LABORATORY CONTROL
RECORD AND REPORT
AUDIT
OTHER Q&A

For drug products formulated with preservatives to inhibit microbial growth, is it necessary to test for preservatives as part of batch release and stability testing?

17/09/2021 | 2775

Similar question:

Reply:

Yes. Two types of tests are generally used. Initially, firms perform antimicrobial preservative effectiveness testing to determine a minimally effective level of preservative. Once that level has been determined, firms may establish appropriate corresponding analytical test specifications. Firms may then apply the analytical tests for preservative content at batch release and throughout the shelf life of lots on stability.

Related Q&A

What should be considered in performing an assessment of whether a firm's drug product, or its components or... See more What should be considered in performing... See more

Some products, such as transdermal patches, are made using manufacturing processes with higher in-process material reject rates than... See more Some products, such as transdermal patches,... See more

Would a paramagnetic or laser oxygen analyzer be able to detect all possible contaminants or impurities in a... See more Would a paramagnetic or laser oxygen... See more

Do the CGMPs require a firm to retain the equipment status identification labels with the batch record or... See more Do the CGMPs require a firm... See more

Can containers, closures, and packaging materials be sampled for receipt examination in the warehouse? See more Can containers, closures, and packaging materials... See more

A firm has multiple media fill failures. They conducted their media fills using TSB (tryptic soy broth) prepared... See more A firm has multiple media fill... See more

Some products, such as transdermal patches, are made using manufacturing processes with higher in-process material reject rates than... See more Some products, such as transdermal patches,... See more

Do CGMPs require three successful process validation batches before a new active pharmaceutical ingredient (API) or a finished... See more Do CGMPs require three successful process... See more

Is it generally acceptable a CGMP perspective for a manufacturer of sterile drug products produced by aseptic processing... See more Is it generally acceptable a CGMP... See more

In 2004, FDA issued a guidance entitled PAT A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality... See more In 2004, FDA issued a guidance... See more

12 >

GMPc Vietnam JSC
Head Office: No. 18, Mang Cam 1 Street, An Lac Green Symphony, Van Canh Ward, Hoai Duc District, Hanoi City
Business location : No. 32, Vi Cam 5 Street, An Lac Green Symphony, Van Canh Ward, Hoai Duc District, Hanoi City
Tel: 0243.787.2242 | CEO hotline: 0982.866.668
Email: contact@gmp.com.vn
Representative Office: 156/1/1, Cong Hoa Street - Ward 12 - Tan Binh District - Ho Chi Minh City
Tel: 0283.811.7383

Quick link

About Us
Services
Project
GMP-Handbook
Video

Consulting for cosmetic facility
Consulting for health supplement facility
Consulting for GSP warehouse

Fanpage

Facebook

Copyright © 2020 GMPc. All rights reserved.

Home
About Us
- Summary information
- Key Personnel
Services
Project
Video
GMP-Handbook
Faqs
News
Jobs
Contact

Hotline: 0982.866.668 Nhắn tin Facebook Zalo: 0982.866.668