Operational qualification , Good

Recommendation on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation and Cleaning Validation. This document is the basis for Annex 15 to the EC Guide on Good Manufacturing Practices for Medical Products. Figure 4 displays the most commonly used topics to be described in a VMP. 

Software and computer systems used in analytical laboratories that must comply with good laboratory practice (GLP) and good manufacturing practice (GMP) regulations require formal validation to confirm that they meet the criteria for intended use. Both new and existing systems, regardless of age, must be validated for their suitability for indented use. Whereas the first three articles in this series [1-3] focused on validation during development, vendor qualification, and installation and operational qualification of new systems, this article describes the procedures for systems that have been purchased, installed, and used prior to formal validation and that must be newly documented. 

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... 

Samples applied with the ATS 4 can be positioned for normal, double-sided, or circular chromatographic development. Analyses performed with this applicator, combined with densitometric chromatogram evaluation controlled by the same PC with Windows-based WinCats software, comply with good manufacturing practices/ good lab practices (GMP/GLP), installation qualification (IQ)/operational qualification (OQ), and 21 Code of Federal Regulations (CFR) Part 11 (drug analysis) requirements. 

Instrumoit qualification is a necessary prerequisite to method develr ment and validation. In essence, if the instrument is not functioning properly, then the results cannot be considered good. Instrument validation includes four steps design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) [80]. These will be presented separately. 

Some of the chemical treatment testing work may fall to a boiler plant operator or laboratory analyst, and such involvement generally is a good idea because it stimulates interest in the boiler-related treatment processes and the chemical programs provided to a site. However, irrespective of the level of technical qualifications held by site personnel,... 

Establish Personal Qualification Pathways Good business practice, as well as CFR 21 211.25, mandates that each employee possess the education, training, and experience to enable him or her to perform assigned functions in a safe and effective manner. The training plan must contain a policy allowing personnel to demonstrate their qualifications. This should cover training and supervisory personnel as well as those directly involved with operations. 

Users should get involved in the qualification process whenever possible. The qualification exercise provides a very good learning opportunity for users to work with the service engineer and learn more about the system s design and functions. Users will gain valuable experience with regard to operation and maintenance of the instrument. 

Beyond the ROI issues, one of the premises for the use of advanced process analyzers is improved product quality. For many industries, and in particular industries close to consumers, there is the need to define procedures and installation qualification/oper-ational qualification/performance qualification (IQ/OQ/PQ) issues, good laboratory practice and good manufacturing practice (GLP/GMP), audit trails, etc. Such requirements open the door for the use of improved analytical methodology, which can be readily provided by the implementation of good process analyzer technology. 

Pharmaceutical Inspection Co-operation Scheme (2003), Good Practices for Computerised Systems in Regulated GxP Environments, Pharmaceutical Inspection Convention, PI 011-1, Geneva, August. ISPE (2001), Qualification and Commissioning Baseline Guide, First Edition, International Society for Pharmaceutical Engineering (www.ispe.org). 

EU Guide to Good Manufacturing Practice, Draft revised version of Annexl5 Vahdation master plan Design qualification, instaUation and operational quahfication, non-sterile process vahdation, cleaning vahdation. 

Before a process can be validated the equipment, facilities, and services used in that process must themselves be validated. Such an operation is referred to as qualification. Qualification is, therefore, an integral part of process validation which, in turn, is part of good manufacturing practice. 

As mentioned before, their advantage lies in their simple applicability and the limited requirements regarding the qualification of their users and the necessary manpower. One of their important disadvantages is the fact that only those hazards and disturbances are addressed which have been compiled in the list. It is not a creative method in this sense. The quality of the method can only be improved by establishing a good feed-back system on experiences gathered in the operational practice. 

In depth defensive measures should be incorporated into the design and operating procedures for radiation sources to compensate for potential failures in protection and safety measures. Protection and safety should be ensured by sound management and good engineering, quality assurance, training and qualification of personnel, comprehensive safety assessments and attention to lessons learned from experience and research. 

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