Equipment description quality control

A description of the facilities equipment and quality control arrangements at the site. 

The production studies will be the last step prior to the industrial production of this mask, which will then be distributed through selective commercial channels to the general public. The production engineering studies will consider the problems of mass production, quality control, detailed written descriptions of the manufacturing processes, specifications of special tools, and equipment inherent to mass production, and the whole process will be filmed. It will provide the manufacturers with specifications for machinery and tools, the prototype plant layout, and all the knowledge with respect to production that a potential producer will need. We feel sure that industry will cooperate. 

In addition to specific polymers, subject entries on equipment, processing and compounding techniques, synthesis, and quality control test methods are included. Rubber and plastic compounders, polymer processing engineers, product development specialists, as well as students will likely find this volume useful. The author has tried to use industry descriptions of terms for the most part, as opposed to oligarchical definitions. References to specific trade names and polymer producers is not an endorsement of products on the part of the author or the publisher. Likewise, the omission of specific product and company name references should not be viewed as a lack of endorsement. This volume is intended as a general aid to industry and academia and not an exhaustive review of the industrial press and scientific literature. 

A description of the facilities and equipment that will be used A copy of the test blueprint for each course A description of the activities and procedures that will be used during the hands-on skills portion of each course A copy of the quality control plan The correct amount of fees... 

Section 1 - Project and Process. This starts with the project definition (objective, description, location, product and raw material specifications, quantity, quality, output requirements, throughput for equipment sizing purposes). Closely linked with this is a statement of the mode of operation (e.g. day time only or 24 hour operation, continuous or batch processing) and expected control philosophy (centralised computer or local, methods of data collection and storage, programmable controllers or hard-wired ). 

Supporting Documentation Supporting documentation should address related procedural and operational needs that must be in place to conduct a well-controlled study and produce high-quality data. Critical elements include standard operating procedures for laboratory operations, records of calibration and routine maintenance of laboratory equipment, storage units, and instrumentation, and a description of all circumstances that have the potential to affect sample integrity (e.g., freezer malfunction, instrument failure, etc.). 

A description of the manufacturing facility, including a company profile plus a description of the premises, equipment, personnel and standard operating procedures relating to manufacture and the quality system. This must lodged with the Medicines Control Council. 

When there is already an existing Preparation Instruction then a referral can be made to this information in the product file. When the preparation is prepared on the basis of in-house decisions and expertise, the considerations which have led to the specific activities are recorded in the file, including the specific work order, the choice of equipment, or the considerations which have led to the inclusion of certain in-process controls. The description of the preparation method must give the pharmacist an overview on the process and should enable him to assess whether a modification might have impact on the quality of the final product. Also it might enable him to trace the critical preparation steps where in-process controls might be in place. 

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