Indian pharmaceutical companies eying global markets have much to adopt from the Pfizer Quality Standards (PQS), framed in a global regulatory perspective, feels Dr PN Rajamani, senior corporate quality assurance auditor, Pfizer Inc., NewYork.

Delivering a lecture on quality auditing practices for the pharmaceutical industry and FDA systems based inspections at a meeting organized by the AP chapter of Indian Pharmaceutical Association on Saturday, Dr Rajamani, a veteran who has audited more than 175 pharmaceutical companies worldwide, said that PQS has the potential to become the primary vehicle for integration and global standardization for Indian companies. Global standardization is a key focus area of Pfizer Quality Integration task Teams, he said.

The PQS, meant for applying to all its manufacturing and distribution sites world over, represents the expected GMP requirements of all countries, he claimed. According to him, one of the major objectives of the system adopted by Pfizer is the minimization of consumers' exposure to adulterated drug products. It helps to determine whether inspected firms are operating in compliance with applicable CGMP requirements, and if not, to provide the evidence for actions to prevent adulterated products from entering the market. PQS is also useful in providing inputs to firms during inspections to improve their compliance with regulations and to continue FDA's unique expertise in drug manufacturing in determining the adequacy of CGMP requirements and guidance documents.

He said that the approach of the company helped the FDA very much and felt that a similar approach from Indian companies would ease the work of the enforcement agencies a lot. The system helps the regulatory agencies as it eases their job by enabling the companies achieve all essential quality standards without any regulatory actions.

The quality system as per PQS consists of separate systems for facilities and equipment, materials and equipment, production, packaging and labeling and laboratory control. As the quality system has an oversight for all other systems, it links all the systems for inspectional coverage.

Dr Rajamani said that quality system includes annual product reviews, complaints, discrepancy and failure investigations, change control, products improvement projects for marketed products, reprocessing, validation oversight and training. He also listed out the FDA criteria for each system.