This document outlines a suitability protocol for microbial limit testing of the drug substance 'ABC' in accordance with European Pharmacopoeia and United States Pharmacopoeia guidelines. The protocol details test methods, performance characteristics, and safety precautions involving various microorganisms. Materials and equipment used in the testing process are also listed, along with references to relevant standard operating procedures.

1. PHARMALIFE-CYCLECONSULTANCY
© Pharma Life-cycle Consultancy
2020
Dimitris Papamatthaiakis
Author
Analytical Quality
by Design
Implementing a compliant validation

2. Microbial limit testing
Method suitability Protocol
1. Purpose
The purpose of this suitability protocol is to set forth the testing
strategy and acceptance criteria for test method “Microbial
Enumeration TAMC/TYMC for ABC Drug Substance”.
This study is conducted according with EP 2.6.12 and 2.6.13
and USP <61> and <62>
The protocol is based on method QC-SOP-MA-xx.
The following performance characteristics will be determined :
• Recovery
• Negative control
• Product control
Five (5) microorganisms are tested for microbial enumeration:
• Bacillus subtilis
• Staphylococcus aureus
• Pseudomonas aeruginosa
• Candida albicans
• Aspergillus brasiliensis
2. Definitions
EP: European Pharmacopoeia
USP: United States Pharmacopoeia
QC: Quality Control
SOP: Standard Operating Procedure
MA: Microbial Analysis
CFU: Colony Forming Unit
TAMC: Total Aerobic Microbial Count
TYMC: Total Yeast and Mould Count

3. Microbial limit testing
3. Materials
The following materials and will be used during the execution
of this protocol:
3.1. Product and media
3.2. Equipment
Name Lot Source Description Exp. Date
ABC xxx Your
Company
API under
examination
02 Jan
2022
Casein soya bean
digest agar
yyy Vendor’s
name
Cultivation
Medium
02 Jan
2022
Sabouraud Dextrose
agar
zzz Vendor’s
name
Growth
Medium
02 Jan
2022
NaCl-peptone broth
(buffere)
aaa Vendor’s
name
Dillution 02 Jan
2022
Name ID SOP reference Calibration Date
Incubator QC-ID-xx QC-SOP-ID-xx 02 Jan 2020
Incubator QC-ID-yy QC-SOP-ID-yy 02 Jan 2020
Laminar air flow QC-ID-aa QC-SOP-ID-aa 02 Jan 2020
pH-meter QC-ID-bb QC-SOP-ID-bb 02 Jan 2020

4. Microbial limit testing
4. Safety
Refer to the Material Safety Data Sheets for ABC, Bacillus
subtilis, Staphylococcus aureus, Pseudomonas aeruginosa
Candida albicans, Aspergillus brasiliensis and all compounds
under the materials section of this report.
Take all necessary precautions when using each compound.
Laboratory safety wear will include a lab coat and safety
glasses. Samples and test solutions containing these
compounds will be handled, stored and disposed in
accordance with applicable Your company Standard Operating
Procedures, and all applicable regulations.
5. Reference
EP Chapter 2.6.12
EP Chapter 2.6.13
USP Chapter <61>
USP Chapter <62>
Your company’s SOP: QC-SOP-MA-xx

5. Microbial limit testing
Are you looking for a personalized solution
towards your own needs?
Please contact us:
https://pharmalifecycle.kartra.com/page/conta
ctus