Qualification of Process Equipment

Qualification of Process Equipment Test Functions and Acceptance Criteria... 

It is noteworthy that the principles and concerns have not changed very much in the last 22 years. To my knowledge, this is also the first general treatise discussing qualification of process equipment and support systems. 

Qualification of process equipment. Define test functions and acceptance criteria for major equipment. A comprehensive list identifying the protocols required shall be finalized, or alternatively, shall be provided by the validation program overview in Step 9. 

Process flow, variables, and responses lyophilized products Qualification of process equipment test functions and acceptance criteria... 

The standard requires that the requirements for any qualification of process operations including associated equipment and personnel be specified. 

A validated manufacturing process is one which has been proved to do what it purports or is represented to do. The proof of validation is obtained through the collection and evaluation of data, preferably, beginning from the process development phase and continuing through the production phase. Validation necessarily includes process qualification (the qualification of materials, equipment, systems, buildings, personnel), but it also includes the control on the entire process for repeated batches or runs. 

Acceptance criteria must be key to achieve appropriate qualification, verification, and individual validation. Acceptance criteria may be consist of various specifications of intermediate and finished products for medical devices. Acceptance criteria also may control parameters for operation of processing equipment and utilities used. 

In step 5, the qualification stage, the critical issue is that the protocol for IQ/OQ of the equipment and the facility include the established method and acceptance criteria. The IQ/OQ report should include the maintenance program to keep the equipment in good condition for reproducibility of the product. For qualification of the equipment and process for terminal sterilization, the following standards should be referred to ISO 13408-1 [6] and 11138-1 [7] for general issues, ISO 11134 [8] and 11138-3 [9] for moist heat sterilization, ISO 11135 [10] and 11138-2 [11] for ethylene oxide sterilization, and ISO 11137 [12] for radiation sterilization. 

All protocols, whether for IQ (installation qualification)/OQ (operational qualification) of new equipment or for validating a new process, have the same... 

Operational qualification Performance qualification Qualification of established equipment Requalification Process validation... 

The validation of a PLC cannot be viewed as a stand-alone operation. PLCs are there for a purpose — to provide automotive functionality. A project Validation Master Plan that details what other validation (equipment qualification, validation of other automated systems) is required. An overall project plan timetable must be in place in order to ensure, e.g., that validation of the PLC does not adversely delay the qualification of important equipment. Where the PLC is to communicate with another PLC embedded into an item of equipment, the link as well as the validated, as well as the individual PLCs, but the link cannot be validated until the software processing the information from the particular I/O point is validated. The deflnition of the boundaries of each validation prevents unnecessary duplication. For PLCs, it is best to use the I/O cards as the boundary. A final check from HMI to the device can then be performed to ensure the system works in its entirety. 

A significant aspect of compliance is validation of the process through qualifications of the equipment installation and operation, process validation and, recently, the development of a cleaning validation. There are summaries describing how to qualify the installation and operation of equipment, piping, valves and instruments [84], The process validation requires evaluating the critical steps, which effect the quality and purity of the final active drug substance [85]. This involves development of a protocol, which states how the validation is to be conducted and defines the data to be collected. The most important part of the protocol is the development of acceptance criteria for the results. 

Qualification of critical equipment, process validation and change control are particularly important in the production of herbal medicines with unknown therapeutically active constituents. In this case, the reproducibility of the production process is the main means for ensuring consistency of quality, efficacy and safety between batches. 

The general text in the main part of these guidelines may be applicable to validation and qualification of premises, equipment, utilities and systems, and processes and procedures. More specific principles of qualification and validation are addressed in the appendices. Semi-automatic or fully automatic clean-in-place (CIP) systems and other special cases should be treated separately. 

Before initiating process validation activities, appropriate qualification of critical equipments and ancillary systems should be completed. Qualification is usually carried out by conducting the following activities, individually or combined ... 

Equipment/Systems Qualification. Qualification of the equipment in which the product is manufactured, the support services, and computer systems supporting the process. 

The standard requires purchasing documents to include, where applicable, the title or other positive identification, and applicable issue of specification, drawings, process requirements, inspection instructions, and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment, and personnel. 

All processes and equipment should be proven capable of performing the task for which they were designed and so should either be subject to qualification tests or process capability tests. There may be documentation available from the supplier of the equipment which adequately demonstrates its capability, otherwise you may need to carry out qualification and capability tests to your own satisfaction. In the process industries the plant is specially designed and so needs to be commissioned and qualified by the user. Your procedures need to provide for such activities and for records of the tests to be maintained. 

To limit the potential for deficiencies to escape detection before the product is released, special processes should be documented in the form of procedures and specifications that will ensure the suitability of all equipment, personnel, and facilities, and prevent varying conditions, activities, or operations. Qualification in the context of special processes means that you need to conduct a thorough assessment of the processes to determine their capability to maintain or detect the conditions needed to produce conforming product consistently. The limits of capability need to be determined and the processes only applied within these limits. In qualifying the processes you need to qualify the personnel using them by training and examination as well as the materials, equipment, and facilities employed. It is the combination of personnel, materials, equipment, and facilities which ensure qualified processes. 

Sec. 820.70 Production and process controls - Address production procedures and process controls, changes to the process, environmental controls, clothing and hygiene of personnel, prevention of contamination, suitability and layout of buildings, equipment qualification, maintenance, periodic inspection, and adjustment, removal of unwanted manufacturing materials from devices and automated (computer controlled) processes... 

Performance qualification Demonstration that equipment/processes operate satisfactorily and consistently during the manufacture of actual product... 

Qualification of the installations to document the ability of the equipment to operate the process described in Section 6.2.2... 

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