Validation performance qualification

Validation Master Plan Design Qualification Installation Qualification Operational Qualification Performance Qualification Validation Reports... 

Validation master plan Specification Risk analysis Design qualification Installation qualification Operational qualification Performance qualification Validation report Process validation plan Process validation program Cleaning validation plan Cleaning validation program Computer validation plan... 

The validation of ne v facilities, systems or equipment is usually accomplished using a four-stage process of design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). 

The validation process is subject to the following design specifications, user and performance requirements, preparation of a master plan/validation protocol (installation qualification, operational qualification, and performance qualification), execution of the protocol, preparation of a summary report, and on-going validation (and revalidation if changes are made). 

In a GLP-compliant laboratory, a data system must meet explicit requirements guaranteeing the validity, quality, and security of the collected data. Operational qualification (OQ) must be performed after any new devices are installed in the laboratory system and whenever service or repair are performed. The role of OQ is to demonstrate that the instrument functions according to the operational specifications in its current laboratory environment. If environmental conditions are highly variable, OQ should be checked at the extremes in addition to normal ambient conditions. Performance qualification (PQ) must be performed following any new installation and whenever the configuration of the system has been changed. PQ demonstrates that the instrument performs according to the specifications appropriate for its routine use. 

Retrospective validation Qualification Validation carried out by review of historical records How an individual element of an overall validation programme performs. When validation of that specific element is complete, it is qualified . When all elements are (satisfactorily) completed the system is validated... 

This chapter defines the terms, responsibilities, requirements and recommended procedures involved in pre-installation, installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), which are all part of a typical HPLC system validation process. As the FDA does not publish a definitive reference or cookbook for these procedures, the suggestions herein are only recommendations. These have been successfully incorporated into formal standard operating procedures (SOPs) that have been implemented at a number of larger pharmaceutical establishments. As long as proper SOPs... 

Following the successful completion of the IQ and OQ protocols, one can then proceed to the post-installation tasks. These tasks include both performance qualification, as well as re-validation, re-calibration and maintenance. 

As with any data generation or data-handling system, appropriate validation (instrument qualification (IQ)/operational qualification (OQ)/performance qualification (PQ)) is required to demonstrate that the system is accurately and reliably performing in accordance with the user-functional requirements. 

Instrument qualification or validation refers to the process of demonstrating an instrument s suitability for its intended use. The first step is to write protocols to cover the four main qualification elements design qualification, installation qualification, operational qualification, and performance qualification. Another qualification element, re-qualification, can be written as a separate protocol or included as part of the PQ protocol. These protocols must be performed in sequence. If the protocol meets its acceptance criteria, then the next protocol in the sequence can be executed. 

The computer system attached to the instrument provides instrument control, data acquisition, data processing, and reporting. According to the draft Analytical Instrument Qualification chapter of the United States Pharmacopoeia (USP) <1058> The manufacturer should perform design qualification, validate the software and provide users with a summary of the validation. At the user site, holistic qualification that involves the entire instrument and software system is more efficient than modular validation of the software alone. Therefore the user qualifies the instrument control, data acquisition and processing software by qualifying the instrument. ... 

Equipment validation comprises installation qualification, operational qualification, and performance qualification. The intention is to demonstrate that equipment is qualified for processing. 

To describe the procedure for validation of the kneading machine to ensure product homogenization and that equipment meets installation, operational, and performance qualifications... 

To describe the validation guideline for performance qualification of computerized equipment to ensure that it meets the performance requirement... 

Steam sterilization validation. All autoclave operations conform to the Master Validation Plan employed at ABC Pharmaceutical Industries. The autoclave has undergone installation qualification, operational qualification, and performance qualification. The autoclave is revalidated on an annual basis. The equipment steam sterilization cycle revalidation data for the autoclave are provided in validated archives. 

When new equipment is purchased or there is a change in the manufacturing site, qualification exercises are performed as part of the validation process. Qualification (installation qualification, operation qualification, and performance qualification) for any equipment or facility is an extreme process which involves testing, verification, and documentation to assure that the particular equipment or facility is per the specification and meets the appropriate standards as defined by vendor and required by manufacturing and engineering personnel [14]. 

FIGURE 1 Validation phases. URS user requirement specification FRS functional requirement specification DQ, IQ, OQ, PQ design, installation, operational, and performance qualifications SOP standard operating procedure. 

The terms instrument qualification and instrument validation are sometimes used indiscriminately. In this chapter, the term qualification refers to the site preparation and the testing employed to demonstrate that the instrument is properly installed in a suitable environment and the performance meets the predetermined specifications for its intended use. Qualification is a part of the whole validation life cycle. Validation refers to the process to provide assurance that the instrument is suitable for the intended application throughout the lifetime of the instrument. Installation qualification (IQ), operation qualification (OQ), and performance qualification (PQ) are performed to provide evidence that the user requirement specifications (URSs), functional requirement specifications (FRSs), and design qualification (DQs) have been met. The sequence of requirements setting and qualification events as well as the relationships between IQ, OQ, PQ and URS, FRS, and DQ are generally illustrated by the V diagram shown in Figure 2. Installation qualification demonstrates the fulfillment of the DQ. Similarly, OQ demonstrates the fulfillment of the functional requirements and PQ demonstrates the fulfillment of the user requirements. 

Validation protocols are required to describe the objective, methodology, and acceptance criteria for installation, operational, and performance qualifications. They are written to ensure test methods, and acceptance criteria are reviewed and approved before qualification of protocols. In practical terms, there are several stages for the production of protocols. First, an acceptable format needs to be agreed. No universal format exists for protocols, but to some extent, the type of equipment, the size of the project, and the personal preferences will dictate the protocol style. However, some norms have been established. Like other controlled documents, protocols are assigned unique reference numbers and revision numbers. They are titled and numbered on every page and have a particular place for approval signatures. Other common elements in protocols tend to be brief descriptions of the item being qualified and a clear statement of responsibilities. 

Equipment System Validation The GMP has special features regarding the equipment, setting several points for the validation, such as design qualification, installation qualification, operational qualification, and performance qualification. Each point must be given in a different document, so four documents must be generated for each equipment. Without any of these documents, the equipment cannot be considered adequate for GMP purposes. GMPs do not refer equipment validations nonetheless, they refer these four items, and therefore, equipment can only be considered validated after the approval of these four documents. 

Equipment validation is comprised of four critical operations design, installation, operational, and performance qualifications. These operations will confirm that the equipment has adequate specifications, installation, and functions, manufacturing a product with adequate properties. After these procedures, whenever equipment is installed, it must be periodically verified and calibrated in order to ensure adequate performance. 

Equipment qualification covers the entire life of a product. It starts when somebody has an idea about a product and ends when the equipment is retired. For computer systems validation, this ends when all records on the computer system have been migrated and validated for accuracy and completeness on a new system. Because of the length of time and complexity, the process has been broken down into shorter phases design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) [2]. The process is illustrated in Figure 17.1. 

Scale-up ensuring that installation qualification, operational qualification, performance qualification (IQ/OQ/PQ) activities are properly conducted These include cleaning validation, process validation, sterilization validation, and so forth, according to established corporate procedures. 

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