Tests for compliance

The installation should be documented. The accuracy of software installation should be verified, and for networked systems, drawings with diagrams should be generated. The instrument should be tested for compliance to user requirements and functional specifications, as defined during the design qualification. Critical parameters should be tested before and during routine analysis. System suitability... 

Regulation also limits the levels of permitted impurities in color additives. Detailed standards of quality and purity have been incorporated into regulatory requirements, establishing maximum amounts of organic impurities such as subsidiary dyes and residues of starting materials, intermediates, or other contaminants. Each batch of color made must be tested for compliance with chemical specifications in order to be certified (130,142,151). Therefore, there is a need for rapid and reliable techniques to separate the dyes from impurities and to monitor the quality of commercial dyes (154). 

The performance qualification (PQ) phase of validation follows the development of the sterilization specifications and of the sterilizer parameters which will deliver them. The purpose of PQ in steam sterilization of pharmaceutical products, equipment, laboratory media, and SIP systems is to confirm that the sterilization specification consistently achieves its intended purpose. The process is run using the parameters derived from process development on (usually) three separate occasions and tested for compliance with a variety of predetermined acceptance criteria. As a subset of PQ, the purpose of bio-validation is to confirm that the lethality expected from the process does not significantly deviate from what is expected. Biovalidation is a test of consistency. If the acceptance criteria are not achieved, there may be need for more process development. 

There are many reasons why quality measurements are needed. Products must be tested for compliance and content, for safety, and to meet a variety of regulations. Quality measurements are also needed to monitor quality during production and in process control. Contracts are written based on standards and terms of procurement that must be tested. Every day, regulatory agencies make decisions based on results which are only as good as the quality of the methods upon which they themselves are based. Quality measurements support international and national trade and support research. Laboratories need to generate credible data and to do so they must have valid methods. 

Random samples of batches of pharmaceutical product(s) supplied by prequalified manufacturers should be taken for independent testing for compliance with final product specifications as part of the continuous monitoring programme. 

To establish quality assurance, control of dosage forms, starting from clinical trial to production for market introduction, must be imposed on in-process operations and product testing for compliance with the specifications and guidelines of quality operation to ensure product attributes. Occasionally, specifications may be revised because of new evidence discovered in the continuous preformulation study. 

Of over one million pounds of Special Purpose lead azide produced, approximately half was not consumed but stockpiled. Later this stockpile material was tested for compliance with the RD 1333 specification and was found to be suitable. After other tests, not covered in the specification and described elsewhere in this volume, the use of Special Purpose lead azide was authorized in place of RD 1333 lead azide in the United States. Since there is such a large stockpile of Special Purpose lead azide, all U.S. CMC-type lead azide needs for several decades could be supplied by this material if it could be preserved for this length of time. The most interesting point brought forward here is that certain process parameters can be varied seemingly without affecting product quality. Others, such as CMC type, have to be held constant to maintain quality. Unfortunately, without empirical studies as conducted by Taylor et al. and Hopper, the knowledge to predict which parameters are critical is not available. 

Purchased membranes were initially tested for compliance with the specifications designed to assure their suitability for winding operations (thickness, tensile strength and elongation) and for their performance characteristics (flux and salt rejection)... 

The period of time during which the drug substance can be considered to remain within the specifications and is therefore acceptable for use in the manufacture of a given drug product, provided that it has been stored under the defined conditions after this period, the batch should be re-tested for compliance with specifications and then used immediately. 

Some starting materials may not be tested for compliance because of the hazards involved (e.g., phosphorus pentachloride and dimethyl sulfate). This is acceptable when a batch certificate of analysis is available from the vendor and when there is a reason based on safety or other valid considerations. 

This material is then to be tested for compliance with the specifications and identification by the Quality Control Department. 

Each delivery should be visually checked on receipt for general condition, integrity of containers), spillage and possible deterioration, and be sampled by personnel and tested by methods approved by the person responsible for quality controls. The samples should be tested for compliance with the starting material specification in.certain circumstances, partial or entire compliance with specification may be demonstrated by the possession of a certificate of analysis, combined with first- hand assurance of identity. 

Self-inspection Testing for compliance with the GMP guidelines initiated by the management... 

A competent authority is also at liberty to request more appropriate specifications if it considers that the monograph is insufficient to assure adequate qualify of the substance. Further to the examples given above which result fi om differences in the synthesis route, additional tests may be required for particle size, polymorphic form, microbial contamination and sterility as necesseury to ensure the correct performance of the starting material in the finished medicinal product. Limits which are tighter than the pharmacopoeial specification may be imposed if appropriate for the particular product in question. In addition, the competent authority will require stability data for active substances on which to base the storage conditions for the drug substance and its re-test period (the period of time for which it is expected to remain within specification and after which it must be re-tested for compliance and used immediately). 

For copper, the rig tests are applied at pumping stations where the water has a high copper solubility. For lead, the rigs are plaeed at the majority of the pumping stations that deliver water to areas with lead pipes. The results from the pipe rig test show a good correlation with metal concentrations at the tap. The Netherlands government has accepted the pipe rig test for compliance monitoring. 

Note.Vas applicable test for compliance with a component standard is, in general, carried out separately. The number of test samples is, in general, the same as that required in the component standard. (1.5.2)... 

The testing temperature - ) is selected within the typical range 25°C to 85°C. When a bituminous binder is tested for compliance to ASTM D 6373 (2007), the temperature is selected from an appropriate table and is within the range 4°C to 88°C. 

Containment integrity should be assessed using appropriate leakage rate tests for compliance with para. 501(b) see paras 656.1-656.12 and 656.21-656.24. 

Visual checks are an important part of the process of testing for compliance. This applies both to the manufacturing processes and to the finished product. As detailed later, regular checks, carried out at an agreed rate and in accordance with an agreed plan, will ensure that a consistent standard is maintained. 

Checklist Analysis. A checklist analysis uses a predefined documented list of items or questions to assess the integrity of systems, processes, procedures, or facilities. The checklist questions are typically answered yes or no. Using checklists is a very prescriptive technique that is frequently applied to test for compliance with standards or regulations. 

The EMM approach couples the large scale sensitivity of moments to the localized demands of the signature property of the wavefunction. It does this through a multiscale procedure that tests for compliance with positivity (in the case of the ground state) over smaller and smaller scales, as the degree of the sampling polynomial, Vc, increases. 

Review all work practices for conformance to slandfitds —Establish hygienic standards and periodically test for compliance —Specify design/quality of personal protective equipment define standards for use —Recommend controls to minimize exposure to environmental hazards —Assist in safe work practices training program... 

The HMRI had the power to reject Railtrack s Safety Case and to question Railtrack on issues within TOC safety cases that they had accepted. It is pertinent to state that as far as this author is aware, no TOC safety case issue accepted by Railtrack has ever been challenged by the regulator. However, the Safety Case has been used by HMRI to test for compliance after an accident, and as it is a legal document, to mount prosecutions on the basis of non-compliance. Railtrack Safety Standards has been carrying out safety case compliance audits as part of its own safety case commitments to control risks imported by TOCs, and HMRI can sample audit the Railtrack audits as a check on their thoroughness. 

The case of German Rail has important implications for the deregulation debate since it has autonomous responsibility for safety. The definition of safety standards and testing for compliance has been the above department s responsibility for decades, and this never gave rise to discussion. What has changed since 1990 is that commercialisation has reached German Rail. Since the government decided to convert the state-owned company into a privately owned joint-stock company, commercial forces have acted on the company in the same way as on all other commercially operated enterprises. 

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