LAL Proficiency Testing - FAQ

1. How easy is it to learn LALPT?
2. How can I be certain that the samples I receive will provide reliable assessment of my proficiency?
3. Can I pre-schedule my proficiency samples orders?
4. Can I order samples at random?
5. How frequently should I have proficiency testing done?
6. How can I correlate my competency examination to proficiency testing?
7. What do you mean by Global Quality Improvement?
8. How do I enter my supplies?
9. How do I receive my results?
10. How can I pay for my samples?
11. What do you mean by extensive technical support?
12. What do you mean by global validation support?
13. What do you mean by Quality Improvement Strategies?
14. Can I send my samples for collaborative testing by the accredited laboratory?
15. How should I send in my samples?
16. Can I send in samples for method validation and routine testing?

1. How easy is it to learn LALPT? LALPT uses a simple intuitive interface which can be learnt in about an hour. But we have made it even easier for our users. Once you sign up, you can practice on LALPT-demo with simulated runs.
2. How can I be certain that the samples I receive will provide reliable assessment of my proficiency? An experienced team of scientists with over 12 years of experience in LAL-endotoxin testing will do the quality control of the proficiency samples, utilizing ICH methods and the FDA approved guideline. The results will be verified and collaborated independently by 2 accredited laboratories of the National Institute of Hygene in Hungary.
3. Can I pre-schedule my proficiency samples orders? Yes. You can download the info by clicking on this link.
4. Can I order samples at random? Yes. You can download the info by clicking on this link.
5. How frequently should I have proficiency testing done? Proficiency testing should be done in the case of qualifying new analysts, also if OOS-retests occur more frequently than expected for analysts, but at least once yearly. Proficiency needs analysis can also be based on the Global Control Chart for analysts; - for example, if an analyst exceeds the 3-sigma limits, then proficiency testing is required.
6. How can I correlate my competency examination to proficiency testing? CACTUS competency training and examination results for "Good LAL Laboratory Techniques" and "Good LAL Method Development and Validation Practices" can be compared to Proficiency testing results. The correlation can provide conversion efficiency value of competency knowledge to practical laboratory use. For example, if you have received 80% or better for "Good LAL Laboratory Techniques" and your Proficiency testing score is outside of the acceptable limits, then competency conversion efficiency is low. Also, if you have received 80% or better for "Good LAL Method Development and Validation Practices" can be compared to Proficiency testing results and your Proficiency testing score over a period of time is within of the acceptable limits with random distribution, then competency conversion efficiency is good.
7. What do you mean by Global Quality Improvement? By providing explicit data on the supplies, reagents, and instrumentation, we will be able to assess the quality and reliability of the vendors and manufacturers. This information will be statistically evaluated and shared between members of the LALPT Proficiency Testing Group.
8. How do I enter my supplies? LALPT includes a default database to simplify entering of the data. You can view the info by clicking on this link.
9. How do I receive my results? The results can be downloaded from a secured web-site or on request we can send it as an Excel compatible e-mail attachment.
10. How can I pay for my samples? Payments can be made in 2 ways: (1) by on-line charging of your VISA or Mastercard, or (2) by on-line ordering and standard mail invoices.
11. What do you mean by extensive technical support? You can experience the extent of our technical support by asking us further questions on LALPT. Click on the link!
12. What do you mean by global validation support? Based on the Proficiency testing of members' input, we will be developing a global library of LAL tests. It will be free-of-charge to current members.
13. What do you mean by Quality Improvement Strategies? As a current member in good standing, you will be able access free-of-charge all of our other databases including: Forum databases and the Warning Letters Knowledge Base. You will be able to interact with the pharmaceutical and biotech global community and get valuable feedback of their experience in solving such problems as: depyrogenation, cleaning validation, international regulations, inspection, environmental monitoring, sampling, etc. Click on Forum database or Warning Letters Knowledge Base and enter a keyword for the search.
14. Can I send my samples for collaborative testing by the accredited laboratory? Yes. Once a year you can send in a sample, testing will be free-of-charge. You will have to pay only for shipping charges. You will receive the most extensive report possible. Click on report.
15. How should I send in my samples? We can provide endotoxin-free (less than 0.005 EU/ml) sample containers at a very reasonable price. Click on catalog.
16. Can I send in samples for method validation and routine testing? Yes. Our accredited partner facility utilizes the most advanced technology in compliance with the ICH, FDA, EU, and JP requirements for reliable LAL-endotoxin determinations at very cost-effective levels. We can provide fast 24-72 hours turn-around results on-line or in e-mail attachment.