Why FDA's OOS Expectations Exist: The Barr Laboratories Case
Why FDA expects strict OOS handling: the 1993 Barr Laboratories ruling on retesting, averaging and outlier tests, and how it shaped FDA's OOS guidance.
Quality Control
OOS Investigation (US FDA): Phase I Laboratory Investigation
Phase I laboratory investigation of an out of specification (OOS) result under US FDA guidance: analyst and supervisor duties, checks and documentation.
OOS Investigation (US FDA): Phase II Full-Scale Investigation
Phase II of an OOS investigation under US FDA guidance: production review, retesting, resampling, averaging, outlier tests and batch disposition decisions.
HPLC Calibration Guide Part 1: Parameters and Procedures
HPLC calibration explained: example calibration parameters and frequencies, with pressure test, drift and noise, oven, flow and gradient checks for QC labs.
OOS Investigation Phase Ia and Ib: MHRA Laboratory Stages
Out of specification investigation Phase Ia and Phase Ib explained as per MHRA guidance: obvious errors, laboratory checklist, hypothesis testing and when to go to Phase II.
OOS Investigation Phase II (MHRA): Retesting and Averaging
Understand the MHRA Phase II out-of-specification investigation: hypothesis testing, retesting, resampling, averaging rules and outlier tests, explained for QC and QA staff.
Out-of-Trend (OOT) Results: Meaning, Detection and MHRA Expectations
What an out-of-trend (OOT) result is, how it differs from OOS, how stability data are trended, and what MHRA's OOS and OOT investigation guidance expects.
SOP for Management of Reference Standards and Reference Solutions
Example SOP for managing reference standards and reference solutions in a QC laboratory: receipt, storage, validity, working standard qualification, labelling and disposal.
SOP for Good Chromatography Practices in QC Laboratory
Example SOP for good chromatography practices in a pharma QC lab: mobile phase, sequence, system suitability, integration, bracketing standards and data review.
Sterility Test: Meaning, Methods, Media and Limits (USP <71>)
What a sterility test is, how membrane filtration and direct inoculation work, media (FTM, SCDM), 14-day incubation and why it cannot prove sterility (USP <71>, Ph. Eur. 2.6.1).