Indian pharmaceutical industry should now work to implement the Lean Validation Concepts: ASTM E 2500 to enable continuous process improvements and real-time monitoring. The concept is a latest trend in the quality control of drug manufacture. The pharma industry should take a cue from global pharma majors like Amgen, Pfizer, Genentech and Bristol Myers Squibb (BMS) which have adopted ASTM E 2500 to achieve 80 per cent reduction in duplication of testing and validation, stated S C Singhal, vice president - Formulation Tech Ops, Dr Reddy’s Laboratories Limited.

ASTM E 2500 concepts are centred on a risk and science-based approach to pharmaceutical and biopharmaceutical manufacturing systems and equipment. In an era where global regulatory authorities are now issuing stringent guidelines, ASTM standards which focus on verification rather than validation, would allow companies in India to speed up many of the process. “This is an alternative to ISPE Baseline Guide. It replaces design qualification with a design review by subject matter experts (SMEs),” Singhal stated while delving on the technological advances in meeting regulatory challenges at the recent DIA conclave.

“The concept is fit for intended use and is not bound by the formal IQ, OQ PQ phases which are industry terms and standards that are not FDA mandated. Now if the pharma industry in India  implements Lean Validation Concepts: ASTM E 2500, it would help enhance knowledge and have a better comprehension of quality by design (QbD),” he said.

“Issues with current validation practices adopted are costly and time consuming. We need to focus on what is critical. This is where Lean Validation Concepts: ASTM E 2500 expunges many of the non value added qualification practices,” said Singhal.

The big advantage of Lean Validation Concepts: ASTM E 2500 over and above its time and cost reduction is that its use is voluntary and therefore going by the value-added benefits it must be implemented in its entirety. There is also a better technical understanding, less waste and repetition. It separates good manufacturing practice (GMP) requirements from ‘folklore’ qualification practices and expectations invented by us in last two decades to avoid regulatory risks. There is definitely more use of Good Engineering Practices, Singhal noted.

The extent of verification and the level of details on documentation are for product quality, patient safety along with the complexity and the novelty of manufacturing systems. The evaluations of the risk and performance is done by subject matter experts who call for the pre-commercial changes with a notification to quality unit for critical aspects only. Therefore it is high time that the Indian pharma industry should go in to implement Lean Validation Concepts to reduce duplication in testing and validation, he said.