Quality Systems

Articles

Real-time experimentation may offer continuous process improvement.

Tools in Waiting: Time for Evolutionary Operation

Identifying and classifying rouge can help to determine CAPA.

Classifying Rouge Helps Define Remediation Procedures

Applying the recommendations of ICH Q10 to statistical analysis can help prevent product recalls.

A Statistical Review of ICH Q10 Pharmaceutical Quality System

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Experts share insights into analytical tools and techniques.

Analytical Tools for a Quality-by-Design Approach to Lyophilization

Applying current principals to traditional factorial designs.

Placket–Burman Designs

Uniform dose formulation is key to meeting safety study requirements.

How to Assess Preclinical Dose Formulation Homogeneity

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Are pharmaceutical manufacturers really serious about ensuring the quality of their medicines? And do they recognize that cutting corners on controls and quality management can be tremendously costly in the long run?

The Cost of Quality Failures

Understanding the differences between convenience, target, and self-selected samples.

Representative Sampling

The authors provide an overview of the new ISPE Guide Series on Product Quality Lifecycle Implementation and how the guides can be used in a complementary way with existing guidance from FDA and the International Conference on Harmonization.

Product Quality Lifecycle Implementation

The authors detail the possible consequences of noncompliance and a lack of quality control.

Quality Assurance/Quality Control