Process equipment quality control manufacturer

Ultrasonic head forming and welding is a fast assembly technique. It is a very rapid operation of about 2 seconds or less and lends itself to full automation. In this process high-frequency vibrations and pressure are applied to the products to be joined, heat is generated at the plastic causing it to flow, and, when the vibrations cease, the melt solidifies. The heart of the ultrasonic system is the horn, which is made of a metal that can be carefully tuned to the frequency of the system. The manufacture of the horn and its shape is normally developed by the manufacturer of the equipment. The results from this operation are not only economical, but also most satisfactory from a quality control standpoint. 

Collectively, the combination of appropriate facilities, equipment, documentation, manufacturing practices and quality control procedures provide a basis for effective product and process control. This is illustrated in Figure 11.10. 

If the product is to be used for pharmaceuticals the GMP rules must be obeyed during plant operation. All chemicals to be tested in clinical studies with humans must be prepared according to GMP. This leads to very detailed documentation since if you haven t documented it, you haven t done it . All procedures for manufacturing and changes in procedures are subject to approval by quality control departments. This decreases the flexibility in process development. Products that are contaminated too much must be reprocessed according to the GMP guidelines. All equipment to be used in the pilot plant must be validated before use. 

Project plans and a dedicated project manager are required to coordinate across-site support activities, e.g. project planning, engineering, process development, production, QC (quality control), etc. This is critically important if production scale equipment and operating areas need to be used during the transfer exercise, i.e. the impact on commercial manufacturing schedules. 

The production of the API and finished dosage form is required to comply with GMP regulations discussed in Chapter 9 and Section 10.2. The quality system, quality control, and validation of equipment and processes have to be developed and adhered to in the manufacturing process. Proper records and documentation are required to be kept in the forms of batch records. 

Facilities and Equipment The technical experts who have an understanding of pharmaceutical science, risk factors, and manufacturing processes related to the product are responsible for defining specific facility and equipment requirements. The equipment must be qualified, calibrated, cleaned, and maintained to prevent contamination and product mix-ups. It is important to remember that the GMPs place as much emphasis on process equipment as on testing equipment while most quality systems focus only on testing equipment. Control Outsourced Operations Quality systems call for contracts with outside suppliers that clearly describe the materials or service, quality specification responsibilities, and communication mechanisms. 

Good manufacturing practice is that part of the quality management system (QMS) that is concerned with the production and quality control of medicinal products (drugs) for human and veterinary use. It includes documentation, personnel training, facility, equipment, and process controls for the manufacture of pharmaceuticals. 

Correspondences in Canadian GMP Code In the Canadian GMP code [12] issues related to production and process controls are mainly covered in the interpretation of regulation C.02.011 (Manufacturing Control) and partly in the interpretations of regulations C.02.005 (Equipment), C.02.014 (Quality Control Department), and... 

Most companies producing ICs today have been quite lax in the quality control of the liquid chemicals used in their processes. These chemicals include acids, bases, buffered etches, photoresists, and organic solvents. Essentially, the producers of ICs have left the quality control of these materials to the chemical manufacturers. Specifications for chemicals are set by SEMI (Semiconductor Equipment Manufacturers International) and are generally met by all chemical manufacturers. The level of metallic contaminations that can exist in U.S. chemicals ranges from 0.1 to 1 ppm. If the levels of metallic impurities were actually this high, U.S. manufacturers would not be able to produce integrated circuits. 

Classic quality control methods normally focus on specification testing of the final product. There may be some concern about controlling the products only with the specification testing of final products (i.e., it should also be required to incorporate the in-process control parameters, such as the specification of starting material and operation condition of equipment for manufacture). These concerns include the following ... 

Critical process steps are usually determined by analyzing process parameters (factors in a process that are controllable and measurable) and their respective outcomes. Not all process parameters affect the quality and purity of APIs namely its impurity profile and physical characteristics. For validation purposes, manufacturers should identify, control, and monitor critical process parameters that may influence the critical quality attributes of the API. Process parameters unrelated to quality, such as variables controlled to minimize energy consumption or equipment use, need not be included in process validation. 

Quality assurance in production is the result of careful planning. In their discussion on quality in manufacturing, Ekvall and Juran [15] refer to setup dominance and machine dominance. The former approach seeks to create a highly reproducible process, which would include a means of self-control. The latter is concerned with the variability that is caused by the equipment s performance. Many older production processes appeared to rely on the machine-dominance strategy because they relied on in-process checks and adjustments as needed. Process validation, however, leans toward setup dominance because this activity seeks to document the fact that the variable process parameters are under control, which means that the in-process test results will be within their specification limits. 

In 1980, the European Organization for Quality Control (EOQC as it was called then, now only EOQ) devoted its seminar in Geneva to validation of manufacturing processes. The discussions were conducted by three working groups general considerations, administration, and control, equipment and support systems, and standard operations. The results of these discussions were summarized in the following commonly accepted conclusions [5] ... 

Quality control experts, such as Shewhart and Deming, decades ago called attention to the importance of minimizing measurement errors in achieving quality control in manufacturing and the importance of statistical monitoring of process data. But tying these concepts to equipment calibration in a statistically rigorous way did not occur until the second half of the twentieth century. 

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