Quality Control

Testing, specifications, and release criteria.

Quality Control

Certificate of Analysis (CoA) — Required Elements and Format

What a compliant Certificate of Analysis must contain and how it is typically structured.

Quality Control

Content Uniformity Testing — USP <905> Method and Acceptance Criteria

How content uniformity is tested under USP <905> and how the acceptance value is calculated.

Quality Control

Dissolution Testing — Method Development and Validation Approach

A structured approach to developing and validating a discriminating dissolution method.

Quality Control

Endotoxin Testing — LAL Method per USP <85>

How the Limulus Amebocyte Lysate test detects bacterial endotoxins under USP <85>.

Quality Control

Microbial Limit Testing — USP <61>/<62> Overview

What USP <61> and <62> require for total count and specified organism testing of non-sterile products.

Quality Control

Out-of-Specification (OOS) Investigation — FDA-Compliant Procedure

The phased investigation approach expected by FDA when a QC result falls out of specification.

Quality Control

QC Laboratory Sampling Plan — Statistical Approach (ANSI/ASQ Z1.4)

How ANSI/ASQ Z1.4 sampling plans are applied to set QC sample sizes and acceptance numbers.

Quality Control

Related Substances Testing — HPLC Method for Impurity Quantification

How HPLC-based related substances methods are structured to detect and quantify drug product impurities.

Quality Control

Stability-Indicating Method — Development and Validation Requirements

What makes an analytical method genuinely stability-indicating, and how that is demonstrated.

Quality Control

Sterility Testing — Membrane Filtration Method per USP <71>

The membrane filtration sterility test method and the controls that make results reliable.