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Supplier Qualification of Your Contract Laboratory
Do you need to audit your contract laboratories as part of your supplier qualification process? Qualifying new vendors can be a labor-intensive, frustrating process with the answers you need oftentimes difficult to obtain. Our team at Particle Technology
USP <1010> for Beginners: An Introduction to Procedure Comparison Studies at PTL
USP <1010> Analytical Data – Interpretation and Treatment provides information regarding the statistical treatment of data generated for chemical and other analyses, with a goal of sound decision-making throughout pharmaceutical development and production. The chapter touches on evaluating
PTL’s Capillary Flow and Technical Cleanliness Test Receive NEW ISO/IEC 17025: 2017 Accreditation
In addition to a recent ISO/IEC accreditation extension, PTL received a new accreditation for two highly sought-after tests. “Our latest tests garnering ISO compliance are the standard test method for pore size characteristics of geotextiles by capillary flow
Behind the Scene Heroes: A Look into PTL’s QA Team from Our Newest Reviewer
At Particle Technology Labs, it may sometimes seem as though our quality assurance team is working in the background—their presence always felt but rarely seen. But, for our clients that rely on results following cGMP guidelines and ISO/IEC
PTL Extends ISO/IEC 17025: 2017 Accreditation Status
Particle Technology Labs, the premier particle characterization service laboratory, is pleased to announce its newest ISO/IEC 17025:2017 accreditation status. “This accreditation is by far the most recognized international standard establishing a lab’s competence and quality,” explains Amy Ganden,
Electronic Records and Signatures: Compliance in the 21st Century
Data integrity is crucial to assuring reliable data. For that reason, PTL has considered and implemented systems that ensure information and data security, integrity, and compliance. 21 CFR Part 11[1] is the key guidance for handling electronic records
OOS Investigations at the Contract Lab
Out of specification (OOS) results are bound to occur at a testing laboratory. It is important that your contract lab investigates the unexpected results in a timely and thorough way. An OOS result occurs when an analytical result
Three Things Your Particle Size Contract Lab Needs to Know to Match Your Specifications
Particle size specifications are designed to ensure raw ingredients and products perform as expected. Often, companies are required to verify that their material is meeting these specifications regardless of which supplier is used. Using a contract lab for
What Is Method Validation and Might You Need It?
By Shane Hill Confidence, reliability—ultimately peace of mind. In short, this is the takeaway following an analytical test method validation. Do you work in pharmaceuticals, cosmetics, or the environmental realm? All of these fields, and more, benefit greatly