Equipment process, qualification

The term approval can be taken to mean certification or qualification, the difference being that certification is performed each time the equipment is repaired and qualification only when the equipment is introduced into service. The standard only refers to the term qualification in connection with special processes, but this clause does not distinguish between special and ordinary processes and equipment. However, there are two levels of approval that apply to processes and equipment initial qualification approval and periodic setting-up approval. 

Validations fall into two types prospective and retrospective. In prospective validation (see flow chart in Figure 2) the validation is done in a sequential manner, involving installation qualification and operational qualification (IQ/OQ) of equipment (e.g., chromatography instrumentation or column hardware). Appropriate calibrations accompany the IQ/OQ. Process qualification, or PQ, involves formal review and approval of a PQ protocol, execution of this protocol, and issuance of a formal PQ report which includes data analysis and recommendations (i.e., approval/certification of the process). If the process is not approved, the report may recommend a redesign or redoing of the validation protocol and, in some cases, a return of the process to process development for further optimization. 

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

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. 

Processes a) Formula change (addition, deietion, excess) b) Equipment change c) Procedure/direction change Process Qualification QA + Concerned dept, managers... 

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]. 

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. 

Qualification Verification. Again, the process validation protocol should reference all items that support the validation the procedures, personnel, methods, and equipment. This section therefore lists and summarizes the various installation, operational, and performance/process qualifications completed for the equipment used in the process validation. These qualifications should list each by equipment name and number and qualification and type. A typical verification section is illustrated below. 

Equipment Equipment number Equipment qualification Performance/process qualification ... 

There is much confusion as to what process validation is and what constitutes validation documentation. We use the term validation generically to cover the entire spectrum of CGMP concerns, most of which are essentially facility, equipment, component, methods, and process qualification. The specific term process validation should be reserved for the final stages of the development and product scale-up sequence. 

User/site acceptance testing of compnterized systems (known as qualihcation) must cover installation, operation, and performance in the wider system context inclnding equipment, processes, and operator interaction (i.e.. Installation Qnalihcation, Operation Qualification, and Performance Qualification). 

Careful control of in-process parameters and evaluation of the performance of the equipment (process performance qualification)... 

The approval of all qualification reports is a confirmation that the computer system as a whole has been proven to fit its purpose and that all essential elements of documentation are available. On computer systems controlling manufacturing equipment (process control systems), the approval of all qualification reports indicates the release of the computerized systems to the Process/Product Performance Qualification. On other computer systems, the approval of all reports indicates the release of the system to the user. 

In a well-designed validation program, most of the effort should be spent on facilities, equipment, components, methods, and process qualification. In such a program, the formalized, final three-batch validation sequence provides only the necessary process validation documentation required by the FDA to show product reproducibility and a manufacturing process in a state of control. Such a strategy is consistent with the FDA preapproval inspection program directive. ... 

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. 

All necessary activities and responsibilities for the qualification and validation are controlled and specified in this Validation Master Plan. Every step of the described validation program for facilities, equipment, processes, process controls, and cleaning is in accordance with the current European Community Guidelines for GMP and FDA, and the cGMP guideline for finished pharmaceutical manufacturers. All requirements in these directives are fulfilled in this validation process. 

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

Qualification of equipment—The qualification of BPC process equipment including reaction vessels, receivers, crystallizers, centrifuges, dryers, filters, distillation columns, solvent distribution systems, etc. is a well-defined activity. While this equipment is somewhat different in design and operating features, than the dosage form equipment that has been the subject of the majority of papers on the subject, the same general principles apply. Reaction vessels, receivers, and crystallizers differ only minimally from formulation and water for injection tanks. Some BPC dryers are identical to those utilized in tablet departments. Solvent distribution systems are piping systems and may resemble WFI distribution systems. Some pieces of equipment such as distillation columns... 

Some medical device manufacturers are confused with the requirements for an equipment performance qualification (PQ). In general, a PQ is not required for manufacturing equipment if its performance is demonstrated during process validation (PV) where the equipment must be shown to perform under the unique conditions of every product (or range of products). A separate equipment PQ is only required when it is used in a manufacturing support role, which typically includes compressed air systems, clean rooms, and purified water systems. 

Finally, the chapter proceeds to discuss how the various aspects of the design are substantiated by first establishing safety demands on SSCs by the process of classification, then demonstrating the appropriate use of industry best practice including code compliance and finally equipment and process qualification... 

This subsection addresses the evaluation of the models and methods used to develop the floor response spectra (FRS) used for piping and equipment seismic qualification and seismic loads acting on structures. All of the systems required for restart are contained in the reactor building, the stack building, the cooling water reservoir (186 Basin), and the process effluent sump structure. 

If the technical staff from the client company recognizes that a toller may be asked to perform new analyses and make operating decisions based upon the results, the client may help the toller develop the needed procedures and skills required to make these decisions. Typically a round robin laboratory qualification exercise will be performed. Samples of known standards and unknown concentrations of the materials to be analyzed for the toll will be prepared and sent to both laboratories. This can help ensure that equipment calibration is synchronized and that the toller is capable of performing accurate measurements. In some cases, the toller may be the party with the chemical, process, or synthesis specific expertise. 

As the cost of testing vast quantities of equipment would be too great and take too long, qualification tests, particularly on hardware, are usually performed on a small sample. The test levels are varied to take account of design assumptions, variations in production processes and the operating environment. 

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. 

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