What technologies and/or practices can Asian pharma manufacturers adopt today, to ensure quality in their products?

Implementation of an effective inspection and controlling system.

The implementation of a quality management system is one aspect, while the appropriate control of it, is just another chapter towards a fully-grown and developed GMP system for quality awareness and good principles in pharmaceutical organizations. So, while the development of inspection systems by government bodies is important, the organization's own internal self-inspection system is also necessary.

Overall, it is important to understand that all of these inspection and audit systems are fulfilled in an independent and objective way so that conflicts of interest (personal, or financial) cannot exist. A good example of this where independent organizations have received accreditation or notification from an official body (for example a government agency) to perform these inspections and audits, this seems the best guarantee for an independent and objective approach.

Quality In process and control testing.

An optimal quality management system is a guarantee for good quality products. But the supply chain is not complete just by organizing and implementing appropriate and effective quality standards. The manufacturing process also should contain testing during the manufacturing operation (quality in process controls) and again at the end of the manufacturing process (quality control testing for release of the medicinal product to the market), during the quarantine stage of a given lot of medicinal product. For example:

- Microbiological in process and quality control testing.
- During the manufacturing operation to check for bio burden on surfaces, in the air of the clean room, and in the vessels used to prepare for the medicinal product.
- After the manufacturing process by a precisely described and statistically valid sterility testing method on the finished dosage drug.

There are many more examples but the testing for microbiological contamination is an important example of how organizations should deal with their quality in process and final product release testing for an optimal patient healthcare environment around the globe.

Use of harmonized and globally accepted quality guidance.

This is important to run globally accepted quality management schemes which are easy to train to people in different regions and that can also be inspected on a global scale. It is also important for the developing pharmaceutical industries in different countries to rely on accepted quality guidance.

By Eize de Boer, PhD, Systems & Services Certification, Global Manager Life Science Auditing