Inadequate investigations, lack of appropriate laboratory systems, repeat issues due to improper implementation of corrective and preventive action (CAPA) have now indicated the need to implement quality metrics, according to AG Raghu, technical director, Gland Chemicals.
Regular monitoring of quality metrics at production plants and R&D labs leads to continuous improvement, he said.
Traditionally, the pharmaceutical industry is a highly regulated environment with little flexibility in which regulators have taken the responsibility for product quality.
However, there still exists blind compliance mentality resulting in variability of production batches. This is because the manufacturers are focussed on delivering high quality drugs and limited focus on process understanding. This calls for the industry to rework on rejects, Raghu said at the recently concluded ISPE event.
Specific parameters that will be continuously monitored by quality department that are considered to be key indicators of the quality, as well as the effectiveness of the GMP systems are the laboratory, production, materials, packaging and labelling, facilities and equipment, he said.
Innovations and improvement have been constrained due to inflexible regulatory environment and focus on compliance not science. Now with a string of warning letters, pharmaceutical industry is in a microscopic scrutiny by global regulators. The US Food and Drug Administration Safety and Innovation Act (USFDASIA) mandates implementation of a risk-based inspection program.
A survey conducted by the International Society for Pharmaceutical Engineering (ISPE) also indicates quality problems are the most common cause of drug shortages, accounting for nearly 46 per cent of all drug shortages. ISPE proposed to focus any further activity on manufacturing and quality issues . The survey report identified metrics to detect and address shortages as a potential improvement opportunity, he said.
Strategies to assess and adopt appropriate quality or other alerting metrics within the pharma industry would prove to be a critical aspect to prevent or mitigate future drug shortages, he pointed out.
ISPE has established a quality metrics project with the following goal to produce a “whitepaper” acceptable to industry on quality metrics, which could be reportable to the FDA to support a risk-based inspection programme included in Sections 704 to706 of USFDASIA.
An objective measure of the quality of a product or process makes considerable relevance to patient recovery. This is where the need to measure the quality of a pharma production site is of utmost importance, because it measures the ability of the facility to manufacture products fit for intended use.
Therefore quality metrics evaluation should be employed as part of management process to ensure maintenance of an effective system. There is also the need to create cross functional teams, said the Gland Pharma technical director.