Product qualification

Should the toller or their client be responsible for final product qualification (that is, certificates of analysis)... 

Product qualification, test data from prevalidation batches... 

Since the definition of validation seems to vary from nation to nation, we will include all activities from design to final product, as well as individual validation, such as process validation [2] (product qualification in ISO). 

Process validation (product qualification), which is performed on each intended product, even when manufactured in the same manufacturing line. According to the master record, the manufacturing must be carried out, in-process control parameters must be monitored, and specification testing of the product must be performed. The result of specification testing must satisfy the requirements. 

When sterilization process is included. ISO requires performing the qualification in the worst case (product qualification). 

The final benefit of validation activity (or QA) requires that production s facilities and equipment be qualified to certify their ability to perform as expected for the validation batches and routine production. Qualification proce-... 

The computer system needs a comprehensive PQ test designed to determine the degree of accuracy with which the system conforms to the requirements specification deliverable. The computer system PQ should not be confused with the process PQ and the product qualification as described in the FDA Guideline on Principles of Process Validation. The PQ occurs under operational conditions but not as part of the actual operational process. The specific test cases include ... 

Performance qualification—those activities that center on the actual product or process being considered. There are other terms, such as process qualification, process validation, product qualification, and product validation, that are sometimes used to narrow the scope of this effort. Here again, semantics have gotten in the way of more important issues. If you desire to use different terminology, go right ahead. Provided all involved understand the intent, the specific title chosen is clearly arbitrary, but the principles are the same. (See Sec. 3.1)... 

Product Qualification FDA (1995) Establishing confidence through appropriate testing that the finished product produced by a specified process meets all release requirements for functionality and safety. 

Hydrophobic filters do not come into direct product contact and, therefore, the standard bacterial retention test alone generally is sufficient validation. However, as hydrophilic filters are in direct product contact, additional validation will be necessary for each product type in order to demonstrate that the filters selected for product sterilization do not alter the safety, identity, strength, quality, or purity of the drug product. Qualification of hydrophilic filters will also be necessary in order to demonstrate that the specific product type, in conjunction with a bacterial challenge, does not affect the efficacy of the filter. Validation of filters by means of bacterial retention tests requires specialist equipment and is often arranged between the filter manufacturer and the BFS operator. 

Such RIM IMR technology has been developed by Dow and 1s 1n the final stages of production qualification at major RIM molders. While the details of this technology are beyond the scope of this paper, the impact of an effective IMR on RIM economics can be addressed. This data 1s shown on "Table X", where one can see cycle times reduced from 120 seconds to 90 seconds the elimination of nonproductive mold cleaning time and the elimination of scrap resulting from external mold release buildup. The reduction in part cost 1s significant the unit cost for the body panel is reduced from 11.72 to 9.55 for an 18.5% production cost reduction. 

Established terms such as batch, bulk, intermediate product, qualification, starting material and validation are used as defined in the WHO Good manufacturing practices for pharmaceutical products (7). 

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

References Addendum Test Report for the Production Qualification Test (PQT) of the ALPHA RADIAC Set, AN/PDR-77, AC ALA s Radioactive Material Handling Safety, and TM 11-6665-365-12 P, The Technical Manual for the PDR-77. The purpose of this section is to provide additional information on the probe beyond that found in TM 11-6665-365-12 P, The Technical Manual for the PDR-77. Refer to that manual for operating information. 

Addendum Test Report for the Production Qualification Test (PQT) of the ALPHA RADIAC Set, AN/PDR-77, Nuclear Effects Directorate, White Sands Missile Range. 

Depending on the complexity of the design, it may be important to meet with the regulatory authorities and obtain their recommendations prior to implementation of the product qualification and stability plan. A bundled submission to FDA could be utilized or a strategy used in which the most critical products are submitted first, followed by lower level submissions (e.g., CBE) for similar products to the same division. 

The following sources of information available via websites cover aspects of plastics ranging from products design, material and process equipment selection, product qualification with cost analysis, industry consumption data, and management recruiting. 

The applications of chromatography are vast and with few restrictions. It plays an important role in the research and development of new molecules in the food industry and in the pharmaceutical industry—especially with respect to purity. It is also very useful for quality control in commercial processes (intermediates), product qualification, environmental monitoring, purification, and so on. 

General purpose grades these have a less stringent product qualification... 

Optical inspection has been discussed elsewhere. It is generally applied early in the fabrication process as a yield improvement and data collection tool, not as a means of final product qualification. However, with improvements in resolution, the type of defect that may escape undetected becomes somewhat more limited, and optical inspection is argued as a possible... 

Normally, user s risk should not be higher than 0.2 in product qualification test. 

Standard Organization (ISO) have helped product developers, designers, and molders to establish correct and useful baselines. An important development in the standardization area is the fact that the American automotive industry has become one of the first to require ISO test procedures for material and product qualifications [7 when the majority testing in the North America is still conducted using ASTM standards. The United States Council for Automotive Research (USCAR) recommended the manufacturers of thermoplastic products to fiilly convert to ISO test procedures by June 1998. 

Draft and design of mechatronic assemblies Production of functional prototypes Reliability analysis, product qualification... 

Implementation of these Pb-free alloys may require considerable effort in component, substrate, and final product qualification. This may include the elimination of Pb-containing solderable surfaces if there is substantial Bi content in the solders. Major costs may be associated with start-up and qualification costs. Alloy-related costs will probably not be a major factor [typically pennies (U.S.) per PWB]. 

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