Supplier Audits Quality Management System

Audits on supplier premises are used to assess a supplier s quality management system at first hand with detailed examination of procedures and documentation relating to a product or service. As discussed earlier, such audits are primarily conducted for suppliers of bespoke (custom) software and systems. 

The pharmaceutical manufacturer is obliged by the regulations to ensure suppliers are suitable to conduct a project. The Supplier Audit is a means to identify the strength of the supplier s Quality Management System and level of experience in the Life Sciences sector. 

Due to the expanding nature of the LIMS market, there are a growing number of suppliers moving into the field. If a pharmaceutical manufacturer proposes to use a new supplier or a new LIMS product, it makes a great deal of sense to conduct a Supplier Audit of the proposed LIMS supplier. If it has been some time since a supplier has been audited (e.g., one year or more), it is recommended that a follow-up audit be conducted to confirm that the supplier s Quality Management System (QMS) continues to be followed. It is important that this audit be conducted prior to placing an order for the LIMS, as there may be some concerns regarding the ability of the supplier to produce a quality product. 

GxP data, records, and documentation including computer vahdation should be archived. Internal audit reports from self-inspections monitoring a pharmaceutical or healthcare company s compliance with its own quality management system do not have to be retained once corrective actions have been completed, so long as evidence of those corrective actions is kept (e.g., change control records). Supplier audit reports and periodic reviews are not internal audits and should be retained. 

The purpose of a Supplier/integrator audit is to allow the pharmaceutical manufacturer to review documented evidence of the application of the supplier Quality Management System (QMS) throughout the development of the LIMS package. The Supplier Audit will also confirm that the supplier is capable of delivering the correct standard of software engineering and documentation for LIMS. 

Because of such uncertainties, each supplier should be audited at the start of the project to establish whether a Quality Management System (QMS) exists that will support the validation of the equipment or process. Where none exists, an agreement must be reached with each supplier as to what quality measures will be used. This should be outlined by each company in their Quality Plan. In our case, we decided that all companies concerned should comply with the GAMP Guide, as this outlines validation documentation that is suitable for the U.S. Food and Drug Administration s (FDA) requirements and may also be used to support the European Union s CE mark accreditation (see Table 40.1). The device was to be released in both the American and European markets. 

During an audit, the supplier aims to present its quality management system, demonstrating the qualification strategy ("say what you do") and the documented evidence that everything is followed during development of a new release ("do what you say"). 

Customers-and the automotive industry in particular-demand certification of a quality management system from their supplier, which is based on one of the earlier mentioned standards. The reason is, that the supplier s own assessment can be dispensed with, as far as possible, because certification is carried out by an independent organization. Granting of a certificate is subject to regular checks (audits). 

The management system is owned by and is the responsibility of the top management, ft is incumbent on the management to review the overall effectiveness and currency of the system and the range of services offered by the laboratory. This should be done annually, and should include input from internal audits, clients, staff, and quality control records. The review should also consider supplier performance, wider management issues, and any changes that have affected the laboratory. The review should be used to... 

Source Code Reviews are used to ensure that controlled development and a consistent programming style have been used. It also checks GMP critical features. Source Code Reviews need a standard against which to check, and programming practices for all programs should be documented. An audit of the supplier s compliance with its own quality management procedures should have been carried out to ensure that appropriate quality is being built into the system. 

It may be useful to supplement self-inspections with a quality audit A quality audit consists of an examination and assessment of all or part of a quality system with the specific purpose of improving it A quality audit is usually conducted by outside or independent specialists or a team designated by the management for this purpose. Such audits may also be extended to suppliers and contractors (see section 8, "Contract production and analysis"). 

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