Production processes, audit

Requirement for audit of product realization and production processes to determine the effectiveness of process performance... 

The process audit to verify that the result-producing processes control products and service within the defined limits. This is now required in ISO/TS 16949 clause... 

Produce audit procedures that cover products, processes, and organizations. 

QAI will perform the in-process audit checks hourly for the packaging of products according to SOP (provide number) and record the observations on form. See attachment no. 1700.30(1). 

In many cases, clinical production or trial runs of a new drug are produced in facilities other than the ones used for full-scale production. The facilities and controls used for the manufacture of the batch or batches are audited. For a generic drug product, the biobatch or biobatches are required to be manufactured in production facilities, using production equipment, by production personnel, and the facility is to be in conformance with cGMPs. Accurate documentation is essential so that the production process... 

Assess the need for an audit. What is the criticality of the software product in business terms Evaluate the risk to the pharmaceutical product, production process, and quality data associated with the software. 

The preparation for inspections shonld inclnde a risk assessment based on the drug product being processed, the production process involved, and the technology mix including the use of computer systems and a review of the company s internal audit and regulatory inspection history. 

Quality assurance (QA) testing and recertification of LAF systems and other engineering controls, which support the aseptic process (process auditing), irrespective of quality control, or procedures to demonstrate conformance with product specifications of identity, purity, sterility, and apyrogenicity (product auditing). 

Engineering Development Manufacturing Quality assurance Qualifies for plant, facilities, equipment, and support systems Qualifies for products and their specific manufacturing processes Operates plant, facilities, equipment, support systems and the various manufacturing processes Audits plant, facilities, equipment, support systems, the various manufacturing processes, and their products... 

Opportunities for P2 at the macroscale can be identified from three distinct perspectives. First, waste-generation audits identify flow rates and compositions of materials in the industrial economy, which are potential P2 targets, from natural resource extraction to consumer product disposal. Second, industrial ecology studies examine the uses and the wastes associated with a particular material. Third, life-cycle analyses (LCA) assess the environmental impacts due to the life cycles of individual products/processes by determining waste generation rates, energy consumption, and raw material usage. 

Production processes All unit production processes in the plant need to be audited to check for process inputs, outputs, operating condihons and controls, and process efficiency. 

For example in a typical batch production process (like textile dyeing), quantity of wastewater discharged at the end of each cycle need to be audited, while in a continuous production process (like pulp processing in a pulp and paper industry), discharge of wastewater may be monitored at four-hour intervals. Care should be taken not to disrupt the normal factory processes. 

The FDA may also want to audit R D to gain assurance that the product development has been done satisfactorily. In particular, the FDA may wish to see data that support the manufacturing process and controls from preformulation, product/process optimisation, clinical trials process validation and stability studies. 

Inspection of an excipient operation may depend on the purpose of the audit and intended use of the excipient Operational limitations and validation of the significant processing steps of a production process should be examined to determine that the manufacturer adequately controls steps to assure that the process performs consistently. Overall, an inspection should determine the excipient manufacturer s capability to deliver a product that consistently meets the specifications listed in the marketed application, or the product specifications needed for research purposes. A team... 

Conformity assessment refers to the demonstration that specified requirements relating to a product, process, or system are fulfilled or conform to specific requirements or standards. Conformity assessment helps to ensure that requirements of standards for consistency, compatibility, effectiveness, and safety are met. Conformity to these requirements can be demonstrated through mechanisms such as regular audits and inspections, and is best affirmed through third-party certification or accreditation. 

For SAP, the first Supplier Audit mentioning validation for GMP regulations occurred in 1993. It was only at this point that SAP was made aware that their pharmaceutical customers had to validate their products and their production processes, including the software products that are part of production processes. In prior years, SAP received only poor feedback from pharmaceutical customers. There had been some rumors and complaints about necessary extensive tests of a new release or version. None of these customers explained to SAP why that had to be done. 

Human factors audits can be applied, as can human factors itself, to both products and processes. Both applications have much in common, as any process can be considered as a product of a design procedure, but this chapter emphasizes process audits because product evaluation is covered in detail in Chapter 49. Product usability audits have their own history (e.g., Malde 1992), which is best accessed through the product design and evaluation literature (e.g., McQelland 1990). 

Fundamentally, these failures reflect the manufacturability of the product, and many are due to the lack of an effective quality control system in manufacturing. Thus, these early failures would show up during process audits, in-process or final tests, life tests, environmental tests, and so on. 

Safety audit reports are written document which the auditors compile in accordance with relevant laws and regulations in order to realize the implementation of a safety audit of the audited entity on the basis of production safety audit opinion. Safety audit report is the direct results of audit work. Safety auditors should work in accordance with the content, scope and requirements of safety audit. And the auditors should also process work papers by sorting and analysis, comprehensive, classification, analysis of audit evidence to identify problems and correct the audit opinion as well as conclusions What s more, those responsible should be asked to sign in safety audit reports. 

Conditions of the supervised both operational and system risk was assured in four organisations realising various kind of production processes. The worked out methodology based on the integrated risk assessment and operational control as well as integrated audit and system monitoring was verified for three years. 

The systems audit should consist of a review of the total data production process, which includes on-site reviews of the field s operational systems, the physical facilities for sampling, sample handling, storage, transportation, and the measurement protocols. 

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