Compliance testing separation

One cannot fail to note the vast expansion of the collection in the last few decades. Surely this was not fueled by additional biologic assays. Underlying the initial growth phase was the widespread utilization of spectrophotometry for identification and assay. Separation science was the second phase in pharmaceutical industry control laboratories. As a corollary, USP and NF method selection moved in the same direction. Spectrophotometric identity tests and assays are more reliable, especially for compliance testing, when performed in the relative mode, which uses a reference standard, rather than the absolute mode, which is the norm in titrimetry. There is some residual difference of opinion in other countries on this point, but that is rendered moot by the widespread adoption of separation science by the pharmaceutical industry and, thus, by the compendia. It is a characteristic of chromatographic methods that a reference standard be required, sometimes more than one for a procedure. The accumulation of modern tests and assays results in 5 to 10 uses for many reference standards. 

In compliance with EURACHEM/CITAC Guide 2 [72] polymer/additive analysis can be considered as a collection of discrete subtasks (Figure 1.3), each consisting of a number of unit processes, themselves composed of modules containing routine unit operations. The unit processes are characterised as being separated by natural dividing lines at which work can be interrupted and the test portion can be stored without detriment before the next step. 

The first section in each set is titled "General Provisions." In this section, in separate numbered paragraphs, the scope of the regulations is laid out (see Boxes 7.2 and 7.3), a number of definitions are listed, and the applicability of the regulations to studies performed under grants and contracts is covered. Also presented is a paragraph that indicates that the inspection of a testing facility is permitted. Besides these, the EPA GLP includes a statement of compliance or non-compliance as well as a statement on the effects of non-compliance. 

The 2000 Washington conference guidelines suggest analyzing at least six independent sources (i.e., six different lots or six different individual samples) of blank plasma or urine separately, and demonstrate that no substances are present that interfere with the quantification of the analyte. The degree of compliance with this guideline changes from lab to lab as the number of independent sources tested. 

Validation is the final step to guarantee that a LC-MS system performs as expected. Validation includes instrument calibration, tuning, testing, and checking of the documentation for completeness, correctness, and compliance with SOPs. Validation consists of four separate steps ... 

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). 

A separate contractor should certify clean-room areas. This might be the TAB contractor if that firm is suitably qualified. There should be no question of equipment being operative at this stage of the project since start-up and testing and balancing are complete. Certification is the verification of facility compliance... 

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. 

Requirements are not specified in the pharmacopeias for sample sizes appropriate to testing batches of non-sterile products for compliance with microbial limits. The test is destructive to the product, and it is extremely unlikely that statistically valid sampling plans are in use anywhere samples composed of 10 1-g amounts taken from 10 separate 15-g tubes of cream, or of three 3.3-ml amounts taken from three separate 500-ml bottles of syrup, may be typical. 

There may first be technical difficulties arising from the breaking of studies into components and their being identified separately as studies . For example, in any study, where study material (samples or specimens) is transferred from one facility or site to another, there is the problem of control over these transfers if such a transfer would not only involve different test sites or facilities, but also the transfer from one study to another, i.e. from the area of responsibility of one Study Director to the responsibility of the next Study Director, difficulties could arise in the assessment of who has had the responsibility for the respective samples or specimens during these critical phases of material transfer. If the whole endeavour is forming one indivisible study, then it is only one Study Director who should be in absolute control also over all of these transfers, and who then will be ultimately responsible for the GLP compliance. 

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 main objective of analysis is to ensure the water supplied to the public meets the relevant standards and does not exceed the recommended concentration of hazardous chemicals. The analyses performed by the water laboratory for compliance purposes should be performed in an accredited laboratory and comply with the recognized standard for technical competence of testing laboratories. A complete analytical procedure should include information on sample handling (collection, transport, and storage), sample preparation (concentrate and separate), analysis (methods to identify and quantify components), analytical quality control (criteria), and reporting of analytical results. 

In categorizing the various weld types, it is possible to separate these types by the time periods in which they were used. C-E qualified each particular combination of weld wire and flux lot at least one time before using a specific heat of weld material. After receiving welding wire and flux material from the suppliers, a weld test plate was prepared which used the specific combination of a heat of wire and lot of flux. This test plate was analyzed chemically and mechanically to assure compliance with all required... 

The class IE dc system is designed in compliance with requirements for physical separation, electrical isolation, equipment qualification, effects of single active component failure, capacity of battery and battery charger, instrumentation and protective devices, and surveillance test requirements. The class IE dc components are housed in seismic category I structures. 

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