Brazilian Academy of Pharmacy, Gonzalez Tablas, Barcelona, Spain
1. CHANGING APPROACHES TO QUALITY
Pharmaceuticals can take a dangerous turn for the patient if they do not have the purported quality. In the past quality was assured by analysis of the finished product and later on by manufacturing in a quality environment which was held on two legs: GMP and validation. Nowadays both approaches are deemed insufficient.
2. THE 21ST CENTURY QUALITY REVOLUTION AND ITS ELEMENTS
Quality of the pharmaceutical products (in its wider meaning that includes biopharmaceuticals, traditional pharmaceuticals, medical devices, specialized foods, etc.) can only be assured by implementing a comprehensive strategy.
Currently quality is the result of the joint application of a patchwork of mutually interrelated elements as shown in the annexed figure.
Figure 1: Quality assurance in the 21st century: the patchwork of quality.
The pharmaceutical quality system is the global frame that ensures quality. It sounds familiar to many because it follows the ISO 9000 model.
GMP is still in the center of the stage but should not be followed blindly. GMP should be analyzed, understood and applied scientifically. Risk management is the element of the PQS through which products and processes are assessed.
Quality should not only be analyzed and manufactured but, previously to that, it should be designed. Only a well understood product can be successfully manufactured.
A product and its manufacturing process can be adequately designed when critical variables are identified and evaluated. This knowledge is gathered during the whole lifecycle of a product. This is why knowledge management can share the experience gathered by pharmacovigilance.
Pharmaceuticals should be patient-oriented. This is why the aim of manufacturing is not only obtaining quality products but delivering them to the patients.
Validation and continual monitoring and improvement rely upon the good knowledge on the product and the identification and management of critical variables.
Quality ensuring processes are continual as manufacturing is.
3. CLUES FOR SUCCESS IN THEIR PRACTICAL IMPLEMENTATION
- The quality apex should be personified by the direction of the organization who carries the responsibility on quality.
- The whole organization should be placed under the umbrella of the PQS and depend on a risk management base (and this requires good hazard knowledge and risk understanding).
- Products and their manufacturing processes should be considered in terms of lifecycle and supply chain.
- Quality is based on knowledge which is acquired during the development and afterwards maintained and progressively increased/modified.
- Validation and continual monitoring and improvement rely upon the good knowledge of the product and the identification and management of critical variables.