May Feature

Technology Helps Manufacturers Create a Manufacturing Compliance Platform - continued

Process analytical technology (PAT) FDA’s process analytical technology guidance proposes PAT as a system for designing, analyzing, and controlling manufacturing by examining critical quality and performance attributes (5). For example, by using PAT, manufacturers can make timely measurements during processing by looking at raw data related to in-process materials and processes. PAT systems examine critical performance and quality attributes during processing to ensure final product quality. The net result is that PAT can reduce risk. Pharmaceutical manufacturers, of course, are required to comply with GMPs, which include methods used in the manufacture, processing, and packaging of drugs. Aligning PAT, Lean Manufacturing, Six Sigma, and GMP compliance results in a robust manufacturing compliance platform (MCP). An MCP serves as an analytical tool to help manufacturers comply with GMP regulations, implement PAT, and manage data recording, retention, and retrieval (see Figure 1). An MCP addresses personnel issues, design controls, purchasing, and acceptance. It also manages materials, document and change controls, equipment and facilities, and production and process controls. A robust MCP brings together statistical process controls; corrective and preventive actions (CAPA); identification and traceability; and batch history records. In addition, an MCP controls and analyzes all the data needed to address service problems, customer complaints, and management concerns. Combining Lean Six Sigma with an effective compliance methodology provides manufacturers with a single version of the facts. Often, analytical processes must rely on several disconnected data sources from suppliers, manufacturers, providers, and patients, as well as myriad data collection and analysis systems. One way an MCP can connect various aspects of a business operation is by coordinating global manufacturing data through enterprise business intelligence (see Figure 2). Enterprise system integration combines information from enterprise resource planning (ERP) and laboratory information management systems (LIMS) with data from programmable logic controllers (PLCs) and supervisory control and data acquisition (SCADA) systems in a way that is streamlined and efficient for pharmaceutical manufacturers. An effective compliance methodology also can provide manufacturers with risk mitigation and control. Document control through high-level oversight and policies and procedures enhances the visibility of areas with the highest risk of noncompliance, as does stringent process definition. Delegation of duties and effective communication up and down the line also enhances exposure of potential risk factors. Task control and standardization help to improve task analysis and enforcement of resultant strategies. Standardizing improvements and checking their implementation through audits ensures that the compliance methodology will be implemented effectively and remain in place. (continued)