Good Manufacturing Practice maintenance practices

CFR 211.67, Code of Federal Regulations PART 211—Current Good Manufacturing Practice for Finished Pharmaceuticals—Equipment cleaning and maintenance, Subpart D—Equipment. 

The establishment and maintenance of a satisfactory system of quality assurance and the correct manufacture of medicinal products relies upon people. For this reason there must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer. Individual responsibilities should be clearly understood by the individuals and recorded. All personnel should be aware of the principles of Good Manufacturing Practice that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs. 

All Production, Quality Control and Laboratory personnel and all other personnel (e.g. maintenance, service and cleaning staff) whose duties take them into manufacturing areas, or which bear upon manufacturing activities, should be trained in the principles of Good Manufacturing Practice and in the practice (and the relevant theory) of the tasks assigned to them. 

EDMS = Electronic Document Management System MMS = Maintenance Management System BMS = Building Management System RCM reliability-centered maintenance SHE = Safety, Health and Environment OEM = Operation and Maintenance CMP = Good Manufacturing Practice IQ= Installation Qualification OQ = Operational Qualification... 

Reardon and Farina (2002) described implementation of a QAS for one of Nestles coconut suppliers in Brazil. Nestle obliged this company to be part of its QAS, a combination of ISO (International Standards Organisation), HACCP (Hazard Analysis and Critical Control Points) and CMP (Good Manufacturing Practices already defined). The incentives for compliance were the large-scale operation, the creation of a reputation, and cost reduction from efficiency increase. Fulfilment was a critical to the maintenance of the company as a Nestles supplier. 

Koelman, E., De Jong, K., and Piket. K. (2000), Maintenance and Support of Validated IT Systems, in Validating Corporate Computer Systems Good IT Practice for Pharmaceutical Manufacturers (Ed. G. Wingate), Interpharm Press, Buffalo Grove, IE. 

Select a total QC strategy to provide an appropriate balance between statistical and nonstatistical QC procedures. With 90% error detection, depend on the statistical QC component and perform the minimal preventive maintenance, instrument function checks, and method validation tests required by good laboratory practice, manufacturers instructions, and regulatory and accreditation guidelines. 

Based on manufacturers recommendations and experience, laboratories perform regular preventative maintenance procedures on the analyzers, with some additional maintenance procedures initiated in response to internal quality control performance or analyzer malfunctions. Calibration and quality control performances should always be checked after maintenance visits because replacement parts and disturbances of the optical and hydraulic systems sometimes adversely affect subsequent analyzer performance (sometimes called PMT—postmaintenance visit trauma). These procedures form part of good laboratory practice. 

The inspection or testing frequency has to be determined. Traditionally this has been based on manufacturer recommendations or on good engineering practice. A recent trend is to establish inspection intervals for individual types of equipment based on results of reliability analyses. Reliability data serve as necessary data inputs to such analyses. In order to establish a database on barrier reliabiUty, it is necessary to tag each piece of equipment and to record its inspection/test, repair and maintenance history. 

System Evaluation and Supplier Assessment Usually there are many choices and suppliers for common COTS laboratory instruments. The user requirements and the operational requirements will provide the basic criteria for the selection. Obviously the chosen instrument must be able to fulfill the key requirements for its intended use. Other factors concerning the instrument such as its ease of use, maintenance, and reputation of the suppliers in terms of quality, reliability, and support should be considered. From a practical point of view, a supplier audit may not be viable or necessary for commonly used COTS instruments. A supplier assessment is sometimes used to evaluate whether the supplier has a good-quality system in place to support the development and manufacturing of the instrument of interest. The need for a supplier assessment depends on the criticality and complexity of the system to be obtained. 

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