The topics every QC lab runs on.
Longer reads on the subjects that cut across every instrument and test: data integrity, validation, investigations, stability and good lab practice.
- 14 min read
Data integrity and ALCOA+ in the QC lab
What data integrity means, the ALCOA+ principles, raw data and metadata, audit trails, electronic records and signatures, the failures inspectors find most often and how good documentation practice prevents them.
For: Students, new QC analysts and reviewers
Read the guide - 15 min read
Out-of-specification (OOS) and out-of-trend (OOT) results
How a QC lab investigates a failing or unexpected result: the phased OOS investigation, hypothesis testing, the rules for retesting, resampling and averaging, when a result may be invalidated, root cause and CAPA, and how OOT results are found in stability trending.
For: QC analysts, supervisors and QA reviewers
Read the guide - 14 min read
Analytical method validation (ICH Q2(R2))
What method validation is, how it differs from verification and transfer, the validation characteristics with typical acceptance criteria for assay and impurity methods, and how a validation runs from protocol to report.
For: QC analysts, students and new validation staff
Read the guide - 13 min read
Stability testing (ICH Q1A(R2))
How stability studies work: storage conditions by climatic zone, testing frequency, batches and packs, photostability, significant change, shelf-life evaluation, stability-indicating methods and the chambers that hold the samples.
For: QC analysts, stability coordinators and students
Read the guide - 13 min read
Reference and working standards
How a QC lab obtains, qualifies, stores, labels and uses primary reference standards, in-house working standards, impurity standards and volumetric solutions — and the audit findings that come up again and again.
For: New QC analysts, reference-standard custodians and QA reviewers
Read the guide - 14 min read
Good practices in the QC laboratory
The everyday GMP expectations for a pharmaceutical QC lab: specifications and test procedures, sampling, reagent and solution labelling, instrument status and logbooks, calibration, analyst training, review of data, retention samples and basic safety.
For: New QC analysts, students and lab supervisors
Read the guide