Knowledge Center
Answers with their sources attached
Specific questions about pharmaceutical quality documents, answered in plain language, each citing the primary source it rests on and showing when it was written and last reviewed.
Guides and requirements
How to use PharmaTrust in 4 simple steps: from free account to your first COA report
Four steps and a few minutes: create a free account, upload a supplier's certificate of analysis, click Analyze and read the report. Plus how to switch the language and how to tell us what you think, with a labelled screenshot of the live product for every step.
What is a COA validator? What it checks and its limits
A plain explanation of COA validator software: what it reads on a supplier's certificate of analysis, what it cannot tell you, where it sits between supplier qualification and the identity test, and the questions to ask before trusting one.
How to check a certificate of analysis, step by step
A reviewer's procedure for a supplier's certificate of analysis: tie the document to the batch, establish the governing standard, compare limits before results, then check methods, dates, signatures and the document's own arithmetic. With the failure modes each step exists to catch.
What must a certificate of analysis for an API contain?
The elements ICH Q7 expects on a certificate of analysis for an active pharmaceutical ingredient: identity of the material and batch, the dates, every test with its limit and result, and a dated signature from the quality unit with the manufacturer's details.
Retest date vs expiry date: what a COA should show
An expiry date ends use; a retest date calls for re-examination. What ICH Q7 says each means, and which date a certificate of analysis should carry.
Certificate of analysis or certificate of conformance: what is the difference?
A certificate of analysis lists each test, its limit and the result. A certificate of conformance states only that the batch conforms.
Can a manufacturer rely on a supplier's certificate of analysis instead of testing?
Partly, and only under conditions. US, EU and ICH requirements all allow a supplier's certificate to replace some in-house testing, but each insists on an identity test of every batch, on establishing the reliability of the supplier's results, and on confirming them at intervals.
How much shelf life must remain on delivery?
WHO answers how much shelf life must be remaining on delivery of medicines in months, not as a percentage, and the months change with the delivery point.
Documents to check before importing medicines
Import paperwork answers three different questions. A map of each document, who issues it, what it evidences and what it does not.
Specified, unspecified and total impurities on a COA
The impurity block on a certificate carries three kinds of limit, and each is read differently. This guide explains specified vs unspecified impurities on a certificate of analysis, and why the total impurities figure is often larger than the sum of the rows printed above it.
Definitions and data
Glossary of certificate terms
Assay, monograph, OOS, retest date, impurity profile and the rest: plain definitions, why each matters on a certificate, and a worked example.
Substandard medicines: the numbers, with sources
The WHO 1-in-10 estimate and the US$30.5 billion annual cost, what they cover, and every source cited and dated.