Introduction to Quality Control

Pharmaceutical Analysis

A branch of practical chemistry that involves processes for identification, determination, quantification, and purification of substances.

Quality Control (QC)

A tool that ensures a product conforms to standards and specifications through inspection, analysis, and action.

Quality Assurance (QA)

A sum total of organized activities performed to ensure all active pharmaceutical ingredients meet the required quality for their intended use.

Accuracy

The closeness of a measurement to the true value.

Precision

The reproducibility of results and measurements in experiments.

Total Quality Management (TQM)

A management approach centered on quality, including participation of all members to achieve long-term success through customer satisfaction.

International Conference on Harmonisation (ICH)

Initiative aimed at standardizing requirements for medicines regulation globally, focusing on quality control methods and validation.

Systematic Error

Errors that arise from controllable variables, including environmental, observational, and instrumental errors.

Random Error

Errors that occur irregularly due to unpredictable fluctuations in experimental conditions.

Determinant Error

Errors that may be avoided or corrected once uncovered, typically known and understood.

Validation of Analytical Procedure

The process providing an exact description of how an analysis is carried out, ensuring methods are accurate and reliable.

Accreditation (ISO)

Quality assessment granting an organization the right to exist in a system, often renewed periodically.