Technical Resources
Hygroscopicity and Packaging: Why Bags Clump in...
A fibre drum arrives with an intact seal and an intact certificate. Inside, the polyethylene bag has been folded and taped, and the powder in contact with the fold has...
Hygroscopicity and Packaging: Why Bags Clump in...
A fibre drum arrives with an intact seal and an intact certificate. Inside, the polyethylene bag has been folded and taped, and the powder in contact with the fold has...
Analytical Method Transfer: The Step Most Buyer...
You qualify a second source, both certificates look fine, and the first in-house retest disagrees by half a percent. The method was the same on paper. The transfer was never...
Analytical Method Transfer: The Step Most Buyer...
You qualify a second source, both certificates look fine, and the first in-house retest disagrees by half a percent. The method was the same on paper. The transfer was never...
Data Integrity in a COA: Can the Raw Data Be Pr...
A clean certificate can be produced from a messy file, and a messy file from a clean process. The difference becomes visible when someone asks for the chromatograms, the sequence...
Data Integrity in a COA: Can the Raw Data Be Pr...
A clean certificate can be produced from a messy file, and a messy file from a clean process. The difference becomes visible when someone asks for the chromatograms, the sequence...
OOT Trends and Batch History: Reading a Supplie...
Every result in the file is within specification and the pattern has still moved. Out-of-trend signals sit in the batch record, not in the certificate, and almost nobody asks for...
OOT Trends and Batch History: Reading a Supplie...
Every result in the file is within specification and the pattern has still moved. Out-of-trend signals sit in the batch record, not in the certificate, and almost nobody asks for...
OOS Investigation: What a Buyer Should Receive,...
A result outside specification arrives by email with one line of explanation. Whether that is acceptable depends on which phase of the investigation has been completed, and on what was...
OOS Investigation: What a Buyer Should Receive,...
A result outside specification arrives by email with one line of explanation. Whether that is acceptable depends on which phase of the investigation has been completed, and on what was...
GDP for API Distributors: What an Audit Does No...
A European buyer reviews a new supplier and finds a valid GDP certificate, a GMP certificate for the production site, and a wholesale authorisation. The file looks complete. Six months...
GDP for API Distributors: What an Audit Does No...
A European buyer reviews a new supplier and finds a valid GDP certificate, a GMP certificate for the production site, and a wholesale authorisation. The file looks complete. Six months...