Core process quality

A system built around the organization s core processes - see ISO 9000 Quality System Development Handbookby David Hoyle (Butterworth-Heinemann, 1998). 

Following approval of the bulk cores by quality control, they are shellac-coated. According to the manufacturing directions, one or two coats may be applied based on the process operator s judgment. A third coat is permissible but only in response to directions from the supervisor. In any event, the actual number of coats applied is recorded in the batch record. Because of its potential impact on drug availability, this information is listed as a critical parameter in Table 3. 

The creation of a process to meet FDA requirements is a multidisciplinary activity. Although the Chemical Process Development organization generates the core process, its shaping and implementation to meet the needs of all other parties involved (particularly Regulatory, Manufacturing, Pharmaceutical Sciences, and Quality Assurance) requires an extraordinary level of collaboration. The principal objective is to produce, and to demonstrate that you have indeed produced, a high-quality API in a well-controlled system of operations. 

Core—the core processes are those that produce product for sale to a customer. For each step in the core process, the critical control points or variables and the acceptable ranges of these variables must be identified. The controls may be done in process by production or off-line in the QC labs. The quality of the core process depends principally on the design of the process and its validation i.e., on its intrinsic capability. 

Supplier—the supplier process is essential for the proper functioning of the core process. The quality of the core process depends to a large degree on the quality of incoming raw and packaging materials. The goal is supplier partnership. The quality of the supplier s own processes directly impacts the quality of your core process. 

Recognized remanufacturing challenges include the procurement of used products, management of core inventory, quality of returned cores, product disassembly, processing/remanufacturing of components, assembly of remanufactured components, quality of remanufactured products, and appropriate pricing of remanufactured products. 

At Systelab, in order to be compliant with safety and customer requirements, we have progressively defined a quality system that integrates as core processes those specified by ISO 62304 (ISO 2006) and that applies a risk-driven approach also to supporting process such as contract and supplier management. 

Core processes that are unique to the laboratory have to be identified and documented preferably using flowcharts (Fig. 1). This stepwise approach allows characterization of each single step, for example, in sample analysis in laboratories (shipment of samples, pre-analytical processing, analysis and post-analytical processing, reporting of results), determination of responsibilities, and documentation of analysis-specific SOP s. All documents are summarized in identical copies of the Quality Handbook that serve as important source of information for the laboratory staff (Fig. 1). 

The simple concept of a Plan, Do, Check, Act (PDCA) methodology called the Shewhart cycle (Shewhart, 1980) can be applied to any safety system. The PDCA has been at the core of quality management efforts for many decades. The cycle has been adapted within the framework of voluntary compliance standards such as ANSI/AIHA/ASSE ZIO Occupational Safety Process (Occupational Health and Safety Systems, 2012) (Figure 13.1). Refer to Appendix P for examples of Advanced Safety Management Systems, (Occupational Health Safety Management Systems, 2012). 

The relationship between the main subsystems and other minor systems is illustrated schematically in Figure 12.4. This places management at the core of the quality system, with the other systems arranged as major and minor satellites that revolve around it. This perspective provides the basis for the Quality System Inspection Technique (QSIT), which the FDA uses for auditing medical device facilities. This is based on a top-down approach, which starts with management controls and then looks at three other key subsystems of Design Controls, Corrective and Preventative Actions (CAPA) and Production and Process Controls. The belief is that by focussing on just these four subsystems, you will actually touch on all the other subsystems and obtain a sufficiently satisfactory overview of the state of compliance of the facility. 

---