Production quality assurance

Production QA is the process whereby the manufacturer adopts a quality system for the manufacture and final inspection of a device. ISO 13485 may also be used as the model in these circumstances, as the design and development elements may be omitted from this standard. The manufacturer must lodge an application with a Notified Body to have his/her system examined. The application must be accompanied by documentation on the quality system and information on any relevant EC type-examined devices. 

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SACHEM Inc., located in Cleburne, Texas, is a producer of high-purity bulk chemicals for companies that have high-purity requirements in their chemical processing. Because the products are of high purity, laboratory operations to assure the quality of the products (quality assurance operations) involve the determination of trace levels of contaminants. Contamination of laboratory samples and materials is of special concern in cases like this because an uncommonly small amount of contaminant can adversely affect the results. The laboratory work therefore takes place in a special environment called a clean room. A clean room is a space in which extraordinary precautions are taken to avoid the slightest contamination. Laboratory personnel wear special clean room suits, nets to cover hair, mustaches, and beards, and special shoes, gloves, and safety glasses to minimize possible contamination. 

The SST was empowered by plant management and had members from every discipline involved in the shipping and handling of monomers at the plant shipping, pumping, production, quality assurance, process chemistry, chemical engineering, and safety/risk analysis. Consequently, it was not difficult to obtain cooperation when requests were made of various entities. 

For products in Classes Ila, lib and III, and AIMDs, examination and certification by a notified body of a specimen product (t)q)e examination Aimex III of the MDD) coupled with a varying degree (partially restricted by product class) of product or production quality assurance (MDD Annexes IV, V and VI), which ensures that the manufacturing process produces products that conform to the certified t)q)e and might involve a quality system for manufacture and final inspection (Annex V), or a quahty system for final inspection and testing (Annex VI). 

Annex VI) or the EC Declaration of Conformity (production quality assurance Annex VII). 

Quality assurance is concerned with maintaining the quality of products to set standards. This embraces the control of incoming materials, the control of compounds produced, the control of manufacturing processes and guaranteeing as far as possible the quality of the final product. Quality assurance schemes utilise physical testing methods as a most important part of their system. In fact most of the standardised test methods are principally... 

At the completion of the documentation, a final report should be drafted to indicate the conclusion and acceptability of the installation. The final report must be approved by the departments that approved the protocol. These are likely to be engineering/technology, production quality assurance/quality control and operations, and the validation manager. Approval of the final report by the relevant departments makes the way clear for proceeding with operational testing. 

Finally, QA is the effort taken to ensure compliance with government regulations for the systems, facilities, and personnel involved with manufacturing products. Quality assurance audits will be quite varied in scope to achieve this assurance. These responsibilities include batch record reviews, critiques of product design, process validation activity, and, possibly audits of other departments operations. 

Quality assurance wasn t satisfied with just having the data meet all the specifications or have a relative standard deviation below 6%. It was not confident that tablets in the batch with lower potency would be adequate to allow the normal expiration date for the product. Quality assurance thus did not agree that the process in the new area should be approved (i.e., validate, especially when data from the earlier blending process indicated a more uniform product. 

Explosion protected electrical equipment for zone 1 (Group II, category 2 G) and the classical firedamp-proof apparatus for coal mines (Group I, category M2) are covered by the B module (EC-type examination) and by the C module (conformity to type) or the E module (product quality assurance). Alternatively, with respect to the B module, the notified body issues an EC-type examination certificate (in German EG-Baumusterpriifbescheinigung), whose marking mainly includes ... 

Product quality assurance (QA) is a particularly tricky business in the dye manufacturing industry. A slight variation in reaction conditions can lead to a measurable change in the color of the product. and since customers usually require extremely high color reproducibility from one shipment to another, even a small color change can lead to rejection of a product batch. 

Flavor Components of Fats and Oils, Lipid Oxidation Measurement Methods, Marine Mammal Oils, Modification of Fats and Oils via Chemical and Enzymatic Methods, Novel Separation Techniques for Isolation and Purification of Fatty Acids and Oil By-Products, Quality Assurance of Fats and Oils, Tree Nut Oils. 

Table 3 Summary of various tests used in friction material manufacturing for raw material and finished product quality assurance...

Production. All operations involved in the preparation of a pharmaceutical product, from receipt of materials, through processing and packaging, to completion of the finished product. Quality Assurance. See Part One. 

All Production, Quality Assurance and Stores personnel and all other personnel (e.g., maintenance, service and cleaning staff) whose duties take them into manufacturing areas, or which bear upon manufacturing activities, should be trained in the principles of GMP and in the practice (and the relevant theory) of the tasks assigned to them. 

A validation programme should be co-ordinated by a multidisciplinary committee comprised of the different functions that are involved in the programme. Typically, the members of the validation committee would be drawn from departments such as production, quality assurance, microbiological and analytical quality control, pharmaceutical development, engineering, and maintenance. The committee approves and issues written protocols, and reviews the data obtained in order to approve or reject the programme results. 

In exceptional cases, with the agreement of the competent authority, the responsibility for production, quality assurance and sales may be assumed by a single specialist if the nature, activity and size of the company so permit and as long as the quality of the manufactured drugs offers every guarantee also under these conditions. 

In vitro and in vivo biocompatibUity tests are required by government agencies for drug delivery system and biomedical device approval [16]. In vitro dissolution testing is used to assess in vivo performance and is important during formulation development as weU as for product quality assurance. Standardized dissolution methods are under development for novel polymeric formulations such as microspheres, nanoparticles, and in situ forming gels [17]. 

Developing and establishing processes and procedures to support product quality assurance systems. 

The specimen or specimens analyzed must be representative of the sample in the context of the study purpose or problem definition, particularly if the sample is heterogeneous. Sampling techniques that are inherently surface sensitive may not yield spectra that are characteristic of the bulk of the sample. Quantitative precision is likely to impose greater restrictions on the choice of the sample preparation method than simple generic fingerprinting studies, since reproducibility will be an essential requirement for most product quality assurance applications. 

The use of analytical instrumentation for continuous online measurement of industrial process streams for real-time information gained popularity in the late 1950s and early 1960s. This information has met various demands, the most notable of which include process control, safety, waste reduction, environmental emission monitoring and control, and product quality assurance. With the application of computers and electronics to analyzer technology in recent decades, online analyzers have become even more sophisticated and widely used. In many instances, the application of online analysis has become a necessity for survival in the face of the economic pressures of globalization in chemical manufacturing. 

The production process of a typical industrially manufac-mred herbal medicinal product includes cultivation or collection from the wild followed by harvesting, drying and fragmentation of the plant material, the preparation of a semi-manufactured product (extract) and the preparation of a finished product. Quality assurance and quality control should be part of all of stages in the process. Good quality herbal medicinal plant products are prepared according to... 

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