In-process inspection and test

Controlled conditions include in-process monitoring and in-process inspection and test. All controls need a verification stage and a feedback loop. You cannot control production processes without performing some kind of verification. 

In continuous production, product is inspected by taking samples from the line which are then examined while the line continues producing product. In such cases you will need a means of holding product produced between sampling points until the results of the tests and inspections are available. You will also need a means of releasing product when the results indicate that the product is acceptable. So a Product Release Procedure or Held Product Procedure may be necessary. The standard implies, however, that if you have released product under positive recall procedures you do not need to hold product while in-process inspection and tests are performed. The reference to clause 4.10.3(a) is also ambiguous because the inspections and tests carried out in accordance with the quality plan or documented procedures may not cover those necessary to verify product on receipt into the plant. It would be wise to hold any product until you have... 

All in-process inspection and test requirements, as specified by contract, are controlled by these means ... 

The in-process inspection and testing is carried out in accordance with the approved test methods, work instmctions, and qualified equipment. For in-process control, statistical sampling techniques are used as appropriate. 

In-processing inspection and testing should be performed based upon monitoring the process or actual sample analysis at defined locations and times. The results should conform to established process parameters or acceptable tolerances. Work instructions should delineate the procedure to follow and how to utilize the inspection and test data to control the process. 

In the approach based on the analysis of historical data, no experiments are performed in retrospective validation, but instead all available historical data concerning a number of batches are combined and jointly analyzed. If production is proceeding smoothly during the period preceding validation, the data from in-process inspection and final testing of the product are combined and treated statistically. The results, including the outcome of process capability studies, trend analysis, etc., will indicate whether the process is under control or not... 

The test sample to have successfully passed all planned in-process and assembly inspections and tests prior to commencing qualification tests... 

Subcontracts enable you to choose the degree of control exercised over your subcontractors. With suppliers, your choices are often limited as you have no privileges. Control over your suppliers is therefore exercised by the results of receipt inspection or subsequent inspections and tests. If your confidence in a supplier is low, you can increase the level of inspection and if high you can dispense with receipt inspection and rely on in-process controls to alert you to any deterioration in supplier performance. 

The requirements pertain to your customer verifying product purchased by you either at your supplier or on your premises. Verification of purchased product is normally carried out by the supplier before or after receipt as part of the purchasing process but may also be carried out by the customer. However, due to the standard locating most of the inspection and test requirements in clause 4.10, the receipt inspection requirements are displaced. 

The standard defines special processes as processes, the results of which cannot be fullp verified bp subsequent inspection and testing of the product and where, for example, processing deficiencies map become apparent onip after the product is in use. 

In which documents do you identify the processes which produce results that cannot be fully verified by subsequent inspection and testing of product ... 

To meet this requirement for documented procedures you will need two types of procedure procedures which provide for the necessary inspections and tests to be planned and carried out at the appropriate stage of the process and procedures for carrying out the specific inspections and tests. However, this is not to say that you need to document how you conduct every type of inspection or test. You only need procedures which define how inspections and tests are to be performed when the lack of them will adversely affect the result. Where the inspection and test methods are no more than using the tools of the trade, no procedures will be necessary providing the acceptance criteria are specified in a specification, drawing, or other such document. 

In defining your inspection and test requirements it is necessary not only to specify what inspections and tests are required and when, but also to define the acceptance criteria and the frequency of inspection and test. Are the acceptance criteria those defined in the product specification or are the limits to be closed to gain better control over the process Is every product to be inspected or are the quantities so large that it would be economically unviable If sampling is to be performed what are the acceptance criteria Answers to these and other questions need to be provided by your documented inspection and testing requirements. 

The standard requires the quality plan or documented procedures for final inspection and testing to require that all the specified inspections and tests, including those specified either on receipt of product or in-process, have been earned out and that the data meets specified requirements. 

Produce procedures for in-process and final inspection and test. 

Devices that you use for product verification at all stages in the quality loop need to be controlled and this includes devices used for inspection and test on receipt of product, in-process, and final acceptance before release to the customer. It also includes devices used during design and development for determining product characteristics and for design verification. Some characteristics cannot be determined by calculation and need to be derived by experiment. In such cases the accuracy of devices you use must be con-... 

The first and foremost element for GMP is the quality system. This can be divided into Quality Assurance (QA) and Quality Control (QC). QA is a total system approach. It sets out the compliance policies and procedures for all facets of drug manufacturing. QC is the practical extension of QA. The role of QC is concerned with inspection and testing of the manufacturing environment, raw materials, in-process intermediates, and finished products. 

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). 

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