Certification for Use in Manufacturing

Validation of a system/equipment/process will be considered complete when its respective protocols identified in the Validation Master Plan have been successfully implemented and the Final Report has been approved. 

A system/equipment/process may be certified for use in manufacturing upon completion of the following. 

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Enhanced turn-over package Installation qualification protocols Operational qualification protocols Change control initiation Cycle development Performance qualification protocol Process validation protocols Validation final reports Validation package Certificate for use in manufacturing Required protocols and procedures for dry production Required protocols and procedures for liquid and semisolid products... 

The use of any dye, harmless or otherwise, to color or stain a food in a manner whereby damage or inferiority is concealed is specifically prohibited by law. The use in food for any purpose of any mineral dye or any coal-tar dye, except those coal-tar tyes hereinafter listed, will be grounds for prosecution. Pending further investigations now underway and the announcement thereof, the coal-tar dyes hereinafter named, made specifically for use in foods, and which bear a guarantee from the manufacturer that they are free from subsidiary products and represent the actual substance the name of which they bear, may be used in foods. In every case a certificate that the dye in question has been tested by competent experts and found to be free from harmful constituents must be filed with the Secretary of Agriculture and approved by him" (21). 

CFR82 4.2.14 Protection of Stratospheric Ozone. A system to track the acquisition and inventory of ozone depleting substances can be used to accomplish the required annual certification that each ozone depleting substance is being used only for laboratory applications and is not being resold or used in manufacturing. 

Category 3 Equipment in this category is intended for use in areas in which explosive atmospheres caused hy gases, vapors, mists, or air/dust mixtures are unlikely to occur or, if they do occur, are likely to do so only infrequently and for a short period only. Equipment or protective systems need to guarantee a normal level of protection. Self-certification (internal control) is allowed in this category if manufacturers have sufficient testing facilities. See Table X/3.2.2-1. 

Two important EU directives, referred to as the ATEX directives (ATEX 100a and ATEX 137), have been introduced concerning equipment and installations in potentially explosive atmospheres. One is an equipment directive covering tiie design and manufacture of equipment for use in hazardous areas the otiier is a users directive dealing with the use and operation of equipment in hazardous areas. These direchves apply to non-electrical as well as to electrical equipment. All equipment and components intended for use in potentially explosive atmospheres (gases, vapours, mists or dusts) need to comply with the requirements of these directives. Certification will be xmdertaken throughout the EU to common rules and procedures. 

Certified testing and approval for control-valve devices used in hazardous locations is normally procured by the manufacturer of the device. The manufacturer often goes to a third party laboratory for testing and certification. Applicable approval standards are available from CSA, CENELEC, EM, SAA, and UL. 

Mechanical Properties. The mechanical properties used for design shall be the minimum values allowed by the applicable material specification or shall be the minimum values determined by the manufacturer in accordance with the test procedures specified in ASTM A370 Methods and Definitions for Mechanical Testing of Steel Products, or by mill certification for mill products. The yield point shall be used in lieu of yield strength for those materials exhibiting a yield point. Yield strength shall be determined at 0.2% offset. 

All aspects of the material s chemical, mechanical and physical properties which are included in the specification should be capable of measurement and certification. For critical duties all material supplied should be fully tested and certified by competent approved, independent test laboratories. All items of plant should be purchased with material certification. Additional certification is required in cases where the fabricator, in manufacturing an item of plant, used techniques such as welding or heat treatment which may affect the corrosion behavior of the construction materials. 

In many instances under GLP, the test substance may be manufactured and assayed for the specific purpose of use in a worker exposure or re-entry study. This is normally done when the amounts of the product to be used are relatively small, and the product is not sold in bulk. In this case, a certificate of analysis should be obtained prior to the initiation of the field portion of the smdy. In this case, the manufacturer should retain some of the material for periodic reassay to meet GLP requirements. 

For standard or proprietary polymer additive blends there is the need for analytical certification of the components. Blend technology has been developed for two- to six-component polymer additive blend systems, with certified analytical results [81]. Finally, there exist physical collections of reference additive samples, both public [82] and proprietary. The Dutch Food Inspection Service reference collection comprises 100 of the most important additives used in food contact plastics [83-85]. Reference compounds of a broad range of additives used in commercial plastics and rubber formulations are generally also available from the major additive manufacturers. These additive samples can be used as reference or calibration standards for chromatographic or spectroscopic analysis. DSM Plastics Reference Collection of Additives comprises over 1400 samples. 

Components are received and are quarantined in ABC Pharmaceutical Industries stores until all testing and certificate of analysis requirements are reviewed and have met the acceptance criteria set forth in manufacturing site standard operating procedures. When all acceptance criteria have been met, the components are released by Quality Control and are ready to be issued for production using the procedures specified in manufacturing site standard operating procedures. 

Finally, it should be recognized that different manufacturing and consulting firms use the term certification in many different ways. Task report conclusions forms represent a type of certification. Some find it useful to issue certifications for IQ, OQ, calibration results, and various stages of validation. 

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