2025MP03R1 Instruction sheet and Result Submission link

PT Round 2025MP03R1

Step 1 of 5

Instructions to Participants

Please read carefully before starting analysis

Quick Safety & Handling

Only trained and authorized personnel should handle PT items.
On receiving the PT item/sample, check that it is intact. If there is any issue, inform the PTP immediately. Record this in the sample receipt acknowledgement link shared by email and submit it within two days of receipt.
Record date of receipt and store under the specified conditions until analysis.
Initiate analysis within 48 hours of receipt.
Treat PT items like routine samples and use standard methods unless otherwise instructed.
Read the detailed instructions/information and follow them accordingly.
Open PT containers only when you begin the analysis.

Instructions for Sample Handling

Visually inspect the samples provided in Sterile Tubes.
Endotoxin Limit of products: 0.25 EU/ml
Potency of products: 0.9 % w/v

Program Details

Program Code: 2025MP03R1 Category: Sterile Pharmaceutical Products Measurand: Endotoxin testing Result Submission: 22 January 2026 Storage: 2–8 °C until analysis

Instructions:

Procedure for Sample Preparation:

Calculation for MVD (Maximum Valid Dilution)

MVD = Endotoxin limit of sample × Potency of the product / Lysate sensitivity (λ)
Concentration of sample to be prepared = MVD/2

Tube no	Tube label	LRW	Sample	CSE	LAL
1	NWC	100µL	—	—	100µL
2	NWC	100µL	—	—	100µL
3	PWC	50µL	—	50µL	100µL
4	PWC	50µL	—	50µL	100µL
5	NPC	50µL	50µL	—	100µL
6	NPC	50µL	50µL	—	100µL
7	PPC	—	50µL	50µL	100µL
8	PPC	—	50µL	50µL	100µL

Tube 1 & 2 = NWC = Negative Water Control
Tube 3 & 4 = PWC = Positive Water Control
Tube 5 & 6 = NPC = Negative Product Control
Tube 7 & 8 = PPC = Positive Product Control

Interpretation of results:

Positive reaction is characterized by the formation of a firm gel when inverted through 180°c in one smooth motion. Record the result as Does not comply (+).
Negative reaction is characterized by the absence of gel that does not maintain its integrity when inverted through 180°c. Record the result as Complies (-).

Reporting of results

Report the results as ‘Complies’ or ‘Does not comply’ only.

Raw Data Submission

Clear photographs of all plates (before counting, with readable labelling).
Photographs of all biochemical / confirmation tests performed (if applicable).
Accepted formats: PDF | Max size: 5 MB each.
Ensure photos are clear, in focus, and labelled with sample code, date and dilution (if used).

Note: Ensure images are in focus and labeled with sample ID, dilution, and date.

Reporting of Results

PT Round: 2025MP03R1

Analytes to Report

For this PT round 2025MP03R1, you are required to report results for the following analytes:

Endotoxin testing

Reporting Basis: Complies or Does not comply

USP 43 Chapter 85

Online submission only: Do not download/print this page. Use the Next button to proceed to result entry.

Key Instructions (Read before you begin)

Do NOT download or print this page…results must be entered and submitted online only.
Use the Next button at the bottom to go to the results entry section.
Double-check all entries before submission — changes may not be accepted after Final submission.
Retain all raw data and supporting records (e.g., plate photographs, biochemical results, calibration logs) as per ISO/IEC 17025.
Upload clear evidence where required — unclear/missing records may lead to disqualification.
Avoid collusion — responsibility lies entirely with the participant.
Click Submit once only — unsolicited re-submissions may result in only the first entry being considered.
If you cannot proceed, ensure all required fields are completed.
You will see a confirmation message upon successful submission.
Use the specified methods, or an equivalent validated method capable of required accuracy. Obtain prior written permission for deviations.
Results in inappropriate formats (e.g., “less than”, “More than”, or zero where not applicable) may not be considered.
Read and follow the PT Protocol carefully before starting analysis.

PT Result Submission

Program Code: 2025MP03R1

Last Date for Result Submission: 22nd January 2026

Note: All fields are mandatory.

Before starting the analysis, please ensure you have read the handling and analysis instructions carefully.

Lab Code(Required)

Please enter a number from 0 to 15.

For lab code, refer to the sample forwarding letter sent along with the sample

Name of Participating Laboratory/ Organization:(Required)

Date of Result Reporting(Required)

As filled in the registration form

Name(Required)

Designation(Required)

Phone(Required)

Email(Required)

Start Date of Analysis(Required)

End Date of Analysis(Required)

Section 1

Sample Vial(Required)

Please select the appropriate vial code

Measurand/Parameter(Required)

Please select the appropriate measurand

Participating ?(Required)

Results(Required)

Method Used(Required)

Accredited as per ISO 17025 scope?(Required)

Section 2