Quality records maintenance

The standard requires the supplier to establish and maintain procedures for the maintenance of quality records. In addition it requires records to be retained in such a way that they are readily retrievable and legible. 

There are three types of maintenance regarding quality records ... 

The procedure is established and maintained for identification, collection, indexing, filing, storage, maintenance, and disposition of quality records. 

Records shall be prepared concurrently with the performance of each step of manufacture, quality control, maintenance, sanitation, etc. 

It should be able to record executed activities in production, quality control, maintenance, storage, distribution and other specific matters related to GMP. 

A system of planned maintenance may be introduced progressively, commencing with limited maintenance routines only on key items of plant and equipment. This may then be extended to a wider range of plant, utilising more complex routines, until such time as a 100% planned maintenance system has been implemented. As with quality systems, maintenance records and histories are essential to ensure smooth operation. 

Objective evidence of the achieved features and characteristics of a product or service and the processes applied to its development, design, production, installation, maintenance, and disposal as well as records of assessments, audits, and other examinations of an organization to determine its capability to achieve given quality requirements. 

The software life cycle activities extend until retirement of the software. However, in a manner of speaking, life cycle activities extend even beyond retirement since the data must be able to be reconstructed at any time during the life of the product, i.e., the archived record must always be accessible and readable even if the software is no longer commercially available or typically employed in the laboratory. Additional software validation includes implementation of the code and integration and performance testing. There also must be system security, change control procedures, audit trails, calibration, preventative maintenance, and quality assurance. 

The computerized systems, both hardware and software, that form part of the GLP study should comply with the requirements of the principles of GLP. This relates to the development, validation, operation and maintenance of the system. Validation means that tests have been carried out to demonstrate that the system is fit for its intended purpose. Like any other validation, this will be the use of objective evidence to confirm that the pre-set requirements for the system have been met. There will be a number of different types of computer system, ranging from personal computers and programmable analytical instruments to a laboratory information management system (LIMS). The extent of validation depends on the impact the system has on product quality, safety and record integrity. A risk-based approach can be used to assess the extent of validation required, focusing effort on critical areas. A computerized analytical system in a QC laboratory requires full validation (equipment qualification) with clear boundaries set on its range of operation because this has a high... 

Cell Bank Maintenance and Record Keeping Cell Culture/Fermentation Harvesting, Isolation, and Purification Viral Removal/Inactivation Steps APIs for Use in Clinical Trials General Quality... 

Each piece of equipment, which is relevant to the tests performed, must have a log book. All changes, calibrations, maintenance etc. must be recorded there. Usually these records are not kept in the quality manual. But a list of all existing log books has to be included. It might be useful to have a guideline on what has to be included in these records. 

The purpose of the GLP regulations is to assure the quality and integrity of the data submitted to the FDA in support of the safety of regulated products. To this end, most of the requirements of the proposal would have been considered familiar and reasonable by any conscientious scientist. Protocols and standard operating procedures (SOPs), adequate facilities and equipment, full identification of test substances, proper animal care, equipment maintenance, accurate recording of observations, and accurate reporting of results are... 

Other instruments for evaluation of electron beam process are real-time monitors. They provide a continuous display in real time of dose delivered to product, as well as the energy of the electron beam. Moreover, they can show the variations in dose across a wide web if multiple detectors are installed and provide alarm signals to warn the operator of high- and low-dose conditions, and record the performance of the processor for production control, quality assurance, and maintenance needs. The major advantage of these real-time instruments is that they monitor the current and beam energy independently. ... 

Quality assurance (QA) involves (a) review and approval of all procedures related to manufacturing and maintenance, (b) review of records, and... 

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