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

FAQS

LABORATORY 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

What are the sampling requirements for sterility testing when a finished product batch of a terminally sterilised medicinal product is made up of more than one steriliser load?

19/09/2021 | 3209

Similar question:

Reply:

The sampling plan for sterility testing should take ac of the definition of a batch as stated in the glossary of the GMP guideline together with the recommendations of annex 1 section 93 (section 127 in the February 2008 revision). Each steriliser load is considered to be an independent sub-batch. Consequently, one sterility test should be performed per sub-batch. The number of samples per steriliser load should conform to European Pharmacopoeia requirements, section 2.6.1.3.

Related Q&A

Can there be any exceptions to this rule? See more Can there be any exceptions to... See more

For an aseptically produced product, where should bioburden monitoring take place? See more For an aseptically produced product, where... See more

What is the maximum acceptable bioburden level? See more What is the maximum acceptable bioburden... See more

What is the background regarding international incidents of glycerol contamination? See more What is the background regarding international... See more

How is the EU patient protected similar contamination occurring in EU products? See more How is the EU patient protected... See more

The registered specifications of our starting materials include conventional or pharmacopoeial methods for the ation of identity but... See more The registered specifications of our starting... See more

What tools are acceptable to use in quality risk management? See more What tools are acceptable to use... See more

How many repeat tests should be conducted? See more How many repeat tests should be... See more

What should be done when the phase 1 investigation does not reveal an assignable cause or evidence of... See more What should be done when the... See more

When is it acceptable to average test results? See more When is it acceptable to average... See more

12 3 4..>

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