טכניון מכון טכנולוגי לישראל
הטכניון מכון טכנולוגי לישראל - בית הספר ללימודי מוסמכים  
M.Sc Thesis
M.Sc StudentHarel Naomi
SubjectAnnual Product Review Model for the Pharmaceutical
Production
DepartmentDepartment of Quality Assurance and Reliability
Supervisor Dr. Avner Halevy


Abstract

An Annual Product Review (APR) is a report required by the FDA according to the pharmaceuticals industry cGMP 21CFR Ch.1 Subpart J 211.180-e. It is universally accepted as an industry quality standard as well.
A written report is required for every drug product, based on data collected at least annually. Contents must specify a list of manufactured batches, release data and reviews of deviations, complaints, recall and returned goods. The GMP does not stipulate methods of evaluation nor sets criteria for quality.
Pharmaceutical companies all over the world face the challenge of complying with this requirement and, at the same time, establish an effective quality system.
The present work is aimed to form a model for utilizing this control tool required and turn it into an active and effective tool for quality management. This concept was implemented in a small Israeli pharmaceutical company, producing a wide range of products in a relatively small production volume. Thus there are numerous annual reports to prepare, but due to small number of batches for each product, there is low volume of data. This creates difficulties in reaching statistical conclusions.
This work describes the implementation steps, problems encountered and solutions reached, combining quantitative and managerial/behavioral tools. Statistical analysis methods make use of individual measurements in each batch as well as relevant parameters common to all batches of similar products. Managerial tools involve the strict planning and execution of management quality discussions.