Packaging processes, audit

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). 

OTHER USEFUL INFORMATION Any errors spotted at this stage should be noted as this could be due to a process error that could affect others (e.g. adjacent storage of two similarly packaged drugs). Audit performed by the pharmacist... 

Packaging processes Packaging sometimes requires specialized systems that can generate wastes. Therefore, such processes must also he audited if waste generation or energy consumption is high in such processes. 

Critical to the successtlil completion of this process are the software tools required to store and analyse the inspection and related data. This is a major task and to achieve this OIS has produced, in conjunction with a major specialist technical software provider, the Asset Condition Evaluation Tool (Acet). Acet is a comprehensive suite of programs which draws on the extensive experience of engineers working in this field for many years, to provide a readily usable and highly auditable package for this application. 

The technical package may specify a scope and frequency for periodic audits and performance criteria that could lead to changing the audit frequency. It may be a general safety and environmental performance audit or a special audit for items such as raw material storage and handling, quality control methods and documentation. The proprietary nature of a process or product or the complexity of the toll could be a reason to establish a more frequent audit schedule for certain tolls. Audits can also be conducted to follow-up on previously identified shortcomings to document that they were addressed properly. 

The process of evaluating the firm s overall operation, such as the laboratories, manufacturing sites, packaging and storage areas, quality systems, and personnel practices is usually a long one and may require an FDA team approach, as discussed above. Having invested in a third-party internal audit that mimics the FDA PAI process is extremely prudent and a smart investment of resources. 

The key to the process is to understand the system that is being proposed. It is good practice for the auditor to spend time reviewing the User Requirement Specification and the system descriptions and understanding of what software categories exist for the proposed system. This should be followed up, with the postal audit checklist. This will also provide valuable information to enable the auditor to plan the audit. Available information should be used to customize the audit checklist to address the specific issues that are relevant to both the supplier and proposed project. Consider, for example, a system that includes hardware and software, where some of the software is custom, other parts are configurable and yet others are part of a standard package. The auditor will need to establish how each part of the system will be developed, and how the build phase will be controlled. There may even be more than one supplier. The auditor would need to split up the main elements and examine how each part of the system will be built. 

There should be a quality unit independent of production that has the responsibility and authority to approve or reject all components, in-process materials, packaging materials, and finished excipients. The quality unit should have the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality unit should be responsible for approving or rejecting excipients manufactured, processed, packaged, or held under contract by another company. The quality unit can delegate these responsibilities if proper controls such as periodic audits and documentation of training are in place. 

For all administrative processes such as stocktaking, primary data management, order writing, invoicing, and auditing of invoices in which the entrepreneur cannot set himself apart in any major way from the competition and for those functions which are statutorily mandated, he will purchase a dependable software package from a reliable vendor. This will not present any problems and has probably been... 

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