Process definition, documentation

The management system for process definition documentation should ensure that the contents of the process documentation package are accurate and complete. A suitable review and quality assurance program should be implemented for the process documentation. This may involve a hierarchical review process, and/or using external experts in a review capacity. 

Procedural controls, process controls, 98-99 Process controls, 96-100 active controls, 98 inherently safer approach, 97 mitigation techniques, 99 passive controls, 97-98 procedural controls, 98-99 safe operating limits, 99-100 Process definition, documentation, 102-104 Process design, documentation, 105 Process hazard analysis (PHA) risk assessment, 92-93 screening methods, 63 Process risk management decisions, documentation, 105-106... 

Process definition and design criteria Process and equipment design Company memory (management information) Documentation of risk management decisions Protective systems Normal and upset conditions Chemical and occupational health hazards... 

As the process flow-sheet is the definitive document on the process, the presentation must be clear, comprehensive, accurate and complete. The various types of flow-sheet are discussed below. 

Process Knowledge and Documentation—The main features here are process definition and design criteria, process and equipment design, company memory (management information), documentation of risk management decisions, protective systems, normal and upset con-dtions, and chemical and occupational health hazards. 

This documentation starts with the process definition. The process definition should include the fundamental process chemistry and conceptual process flow configuration, including major steps or unit operations to the extent known. 

The process definition should be documented in a single document or set of documents, bringing all process-related information together. The management system for this component must reflect many considerations. 

Figures 3 and 4 illustrate how a biennial document review process and document processing cycle time metrics faltered in their early stages due to lack of process ownership, definition, and management review. This situation presented a compliance risk to the organization and resulted in poor business efficiencies. Improve-...

The contents of the manual are divided into three major sections objectives, quality manuals, and standard operating procedures. The first section addresses the definition of quality, basic changes, correspondence between international standard ISO 9001 (1994) and ISO 9001 2000, and the process of documentation development and application for registration and certification. 

Unfortunately, there is still much confusion as to what process validation is and what constitutes process validation documentation. At the beginning of this introduction several different definitions for process validation were provided, which were taken from FDA guidelines and the CGMPs. Chapman calls process validation simply organized, documented common sense [6], Others have said that it is more than three good manufactured batches and should represent a lifetime commitment as long as the product is in production, which is pretty much analogous to the retrospective process validation concept. 

Evaluation is defined as the practitioner s determination of the patient s outcome and clinical status at planned intervals. Evaluation represents accountability in the definition of a pharmaceutical care practice. This accoxmtability is witnessed at the patient level by the practitioner assuming responsibility for finding out exactly what happens to the patient in the medication use process and documenting these results or outcomes. 

Therefore, it is the first task of the business process owner to define which records under his area of responsibility are electronic records and which not. The best approach is to have a defined and documented business process. Then the records growing out of this process can be determined. In the next step, systems supporting the process are identified, and records in the system assessed. The business process definition will also be needed as a basis for the record risk assessment and validation activities of a system. An example on how this can be documented is given in Fig. 2. 

There is much confusion regarding the definition of process validation and what constitutes process validation documentation. The term validation is used here generically to cover the entire spectrum of current GMP concerns, essential most of which are facility, equipment, component, method, and process qualification. Based upon the FDA process validation guidelines, the specific term should be reserved for the final stage(s) of the product and process development sequence. The essential or key steps or stages of a successfully completed development program are shown in Table 1. 

WS1] WfMC. 2002. Worlflow Process Definition Interface—XML Process Definition Language (XPDL), Document WFMC-TC-1025 FINAL. 

Examples of deliverables are system requirements definition document request for proposal (RFP) document systems-evaluation criteria software and hardware configuration design system-implementation project plan and facilitation assistance during the system-implementation process. 

Document registration and coding Version and configuration control Storage, retrieval and backup Editorial standards Common terms and definitions Document templates, branding and copyright notices Peer review and sign-off processes... 

Definition of master documents, specification and verification documents for all regulated processes Definition of regulated processes (SIPOC model) [3]... 

Production launch, distribution and service Process definition Working instruction, Spare part need to be well documented 7.1,7.2, 7.4 ... 

Figure 1 illustrates how the reference to evidence, using summary documents and process definitions fiiat justify the process, might appear in a safety argument constructed using GSN. 

Complete process knowledge System definition document... 

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