Equipment maintenance and calibration

The term quality control (QC) is applied to procedures used to provide evidence of quality and confidence in the analytical results. It includes use of blanks, replication, analysing reference materials or other well-defined samples and participation in Proficiency Testing schemes. Several other features of analysis forming part of QC are control of reagents and instrumentation, equipment maintenance and calibration, and procedures for checking calculations and data transfer. It should be noted that what is referred to as quality assurance in the UK is known as quality control in Japan. 

Equipment maintenance and calibration records GLP protocols and amendments QA audit records Standard Operating Procedures Final Study Reports and QA Statements Training records Job descriptions... 

The OECD covers a series of activities and personnel. Responsibilities, training, quality assurance (QA), standard operating procedures (SOPs), study plans and study reports, data production and recording, equipment maintenance and calibration, computers and validation, test systems and test substances, and archiving are the primary areas covered by the GLPs. 

Elimination of equipment maintenance and calibration in a biopharmaceutical environment, these costs and associated records can be substantial. 

Check HVAC maintenance records against equipment lists. Collect existing maintenance and calibration records and check them against the construction documents (e.g., equipment lists and mechanical plans). Equipment that has been installed in inaccessible or out-of-the-way locations is frequently overlooked during routine maintenance. 

Quality systems require that facilities and equipment should be appropriate to the activities undertaken. Surfaces that are easy to clean and maintain in hygienic condition are a requirement in many situations. For example, cloth-backed chairs would not be acceptable in a laboratory that handled potentially biohazardous materials. Equipment should be checked at installation to demonstrate that it can perform its desired function. This is frequently done using an Installation Qualification, Operational Qualification and Performance Qualification (IQ /OQ/PQ) commissioning process. Routine maintenance and calibration programmes are then required to ensure that equipment continues to deliver the specified performance. 

An organized document filing system must be maintained. This could be a paper file, an electronic document file, or a mixture of both. The equipment inventory system contains key information on the components of each system, their performance criteria and maintenance and calibration status. All documents including installation and performance documentation, as with other documents necessary to demonstrate the quality of the data, include SOPs for the qualification procedures, calibration, maintenance, personnel training, etc. If the manufacturer s operating, service, or maintenance manuals are used or cited in the operating procedures, copies of these manuals should be maintained. To facilitate retrieval, documentation should be stored in a central location and be indexed for easy retrieval. 

The purpose of the regulations was to ensure proper operation of laboratories that generated data to support either INDs or NDAs. In particular, they addressed animal studies, including animal care and animal accountability. They also involved the equipment used to do the various procedures for analysis and the maintenance and calibration of the equipment. In general, these regulations now cover the operation of the laboratories and how the data are collected and... 

Maintenance and calibration of equipment Standard operating procedures... 

Design and Construction Equipment Maintenance and Cleaning Calibration Computerized System Documentation and Records... 

Subpart D presents the regulations for the equipment used in a study. There are two subsections in both sets, the FDA and the EPA GLP one for equipment design and one for maintenance and calibration. The text of both sets are virtually identical, stating that all equipment must perform as required by the... 

Check the Code of Federal Regulations, Chapter 40, Part 160.81, and tell whether an SOP is required for maintenance and calibration of equipment. 

When appropriate means that a laboratory only need specify remedial action in response to equipment failure or malfunction when remedial action is appropriate to the piece of equipment. A laboratory may elect to discard rather than repair faulty equipment however, records for the discarded equipment, including records of previous maintenance and calibration, must be retained for the length of time described in 58.195(b) and (f). 

Equipment validation is not reliable, and several special features are required instead. GMP is concerned with several procedures before the equipment is placed into the service. After entrance into service, maintenance and calibration must be made periodically. The following focuses on the procedures required for new equipment to enter into service. 

The coating process (equipment design, process parameters employed, maintenance and calibration programs, etc.)... 

Review maintenance and calibration of equipment, placing special emphasis on QC acceptance criteria. This can be accomplished... 

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