Validation equipment

All equipment has limitations, for example, the amount of a substance it can detect or the accuracy with which it can make a measurement. If you attempt to make the equipment perform beyond its capabilities, it does not matter how carefully the equipment is operated, it will not be possible to get meaningful results. In terms of a particular instrument, fitness for purpose is interpreted as having appropriate performance capability to do the work required. This applies to all equipment, large or small. For example, a stirrer needs to perform the intended task satisfactorily while remaining essentially inert. There is a formal process for assessing the suitability of equipment to perform a given task - this is called Equipment Qualification or Equipment Validation. This is dealt with in Section 5.6.3. 

Indeed, the need for capital investment in a CMO may not have been originally anticipated or planned for and may impact on the whole decision making process. Additional costs and time need to be set aside for training and equipment validation, e.g. PQ/IQ/OQ (process qualification/ installation qualification/ operational qualification), and if this includes equipment with radically different operating principles than currently available on site then additional costs will be required for equipment-specific operating personnel and training. 

Equipment List of equipment used, validation of the equipment, validated methods for cleaning, and procedures for contamination control... 

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

Process and equipment validation certification guideline Hot air sterilization tunnel certification/validation guideline Steam sterilization certification/validation guideline Validation and certification of hot air sterilization tunnel Validation and certification of SIP preparation/mobile vessel Validation/revalidation of sterilization cycles in sterilizer by Kaye validator... 

Cloud R, Pharmaceutical Equipment Validation Qualification, Interpharm Press, Buffalo Grove, IL, 1998. 

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 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. 

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. 

Process validation Inspection of the establishment to determine compliance with cGMP requirements and adherence to application requirements is a Field responsibility. CDER may request data to support validation of sterile processing operations for example, environmental monitoring, equipment validation, sterile fill validation, and associated sterile operations. 

Running these in series and in parallel, much time can be conserved. The three stages with respect to equipment qualification are sometimes referred to as Equipment Validation, comprising IQ, which ensures that a piece of equipment has been correctly calibrated and installed in accordance with the equipment manufacturer s recommendations (proper voltage, amperage, clearance from wall, exhaust requirements, etc.). It is important to understand that IQ is also required for all utility systems. In most instances, once... 

Syed Imtiaz Haider has a Ph.D. in chemistry and is a quality assurance specialist with over 10 years of experience in aseptic and nonaseptic pharmaceutical processes and equipment validation, in-process control, and auditing. Dr. Haider is the author and co-author of more than 20 research publications in international journals dealing with products of pharmaceutical interest, their isolation, and structure development. He is a professional technical writer and author of more than 500 standard operating procedures based on FDA regulations, ISO 9000, and ISO 14000 standard. 

Cloud, P. A. Pharmaceutical Equipment Validation—The Ultimate Qualification Guidebook. Englewood, CO Interpharm Press (1998). 

Where the results of a process cannot be fully verified by subsequent inspection and tests, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented. 

Figure 10 Related activities for transdermal process and equipment validation.

One interesting variation of CRS validation when compared to equipment validation is that software is not inherently linked to a unique piece of computer equipment, yet it does require some form of suitable computer equipment for operation. One can streamline the CRS validation process by testing the software using computer hardware other than the final hardware on which the software will eventually be installed for use. This means that validation testing can start using a pilot hardware system while the final hardware is, for instance, still being procured and installed. 

Contract process SOP + segregation summary of systems and equipment validation... 

Equipment validated under a specified set of conditions must be revalidated whenever there is a change in those conditions. For example, changes in application software may influence the correct functioning of the computer system. Revalidation refers to those items of the system that are affected by the change. 

A document in which the records, results and evaluation of a completed validation programme are assembled and summarized. It may also contain proposals for the improvement of processes and/or equipment. validation masterplan (VMP)... 

Various types of validation generally required in biopharmaceutical manufacturing include process validation, facility and equipment validation, analytical method validation, software validation, cleaning validation and expression system characterization. Combined with other elements of cGMP, including lot release testing, raw material testing, vendor quality certifications, and vendor audits, the quality of product can be consistently assured. 

Facility and equipment validation is normally divided into design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Equipment validation begins with pilot production of clinical materials for Phase II. 

A variety of examples and case studies are given to show the wide range of application. Assay and bioassay validation, process and equipment validation, etc. Not all cases are end point validation, but are further up-stream, and part of the life cycle validation discussed by Chapman (6). 

A program to ensure control of critical system documentation will be established. The files will be controlled by QA. Validation and centralized for easy retrieval. Equipment validation data such as operating and service manuals, purchase orders, manufacturer specifications, as-built drawings and schematics, spare parts lists, and any other information pertaining to the system will be included in the file. Separate validation files for Facility, Systems, and Process validation of each product, including all related data, will be maintained. Procedures will be developed to create files for new equipment, update information for existing equipment, control, removal, and return of information, etc. 

The observations made during the execution of the VMP provide strength to significantly reduce the regulatory risks related to the systems and initiation of the proactive corrective actions required. The plan provides visibility for the completion of individual tasks and assures system evaluation, process validation, equipment validation, facility and utilities qualification, documentation, environmental control, and monitoring implementation and execution of the VMP assures process reproducibility control over the applicable changes and modifications as a result in facilities, equipment, personnel, and materials. 

Derived from relevant samples using validated methods developed on qualified equipment/validated computerised analytical systems... 

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