Reference standards documentation

Reference standard documentation (chain of custody, certificate of analysis) should correspond to the information given on the container labels. If labeling is unclear, inadequate or inconsistent with paperwork or nonexistent, the suppher should be contacted for clarification. If discrepancies caimot be resolved and proper identification cannot be made, the reference standard should not be used. 

The standard requires controlled conditions to include compliance with reference standards/codes, quality plans, and/or documented procedures. 

In which documents do you define the reference standards, codes of practice, quality plans, and procedures to be complied with during production ... 

The quantitative analysis is only as good as the reference material allows. The reference standard is used as the primary standard against which all determinations are made. Reference standard characteristics should be appropriately determined and documented for each batch. Copies of this documentation must be included with study records and must be available for inspection. The reference standard should be (1) of the highest purity obtainable, (2) independently characterized to establish identity, strength or potency, and purity, (3) in the most stable form, and (4) stored under suitable conditions. 

This information should be included in documentation such as the certificate of analysis (CoA), test article characterization (TAC), and reference standard profile. Certified reference standards can be purchased from appropriate suppliers. If standards are not available, the recommendation is to collect or synthesize enough material, and analyze, certify, and use it as the standard. Following are some considerations ... 

Information concerning reference/calibration standard compound, potency, and reference for documentation of standard preparation. 

Maintenance records of reference standards, stock standard solutions, and working standards are not complete, and a method of handling these standards is not properly documented. Storage of stock and working standards, labeling of all standards, and a plan for disposal are not well defined. 

Reference Standard. Characterization and structure elucidation data are typically derived from tests conducted on the primary reference standard. Its suitability must be documented by information much more extensive than prescribed in the specifications. In addition to the prescribed analyses—especially levels of impurities—other tests normally conducted include elemental analysis and ultraviolet, infrared, nuclear magnetic resonance, and mass spectrometry, along with reviews of each providing assignments of the important features supporting the structure(s) of the drug substance. Other tests such as... 

Include documentation supporting the integrity of the reference standard. 

The described approach has been already applied when developing a coastal mobile hardware complex [11]. Software and hardware support of this complex comprises a database on standard documents in the radiation protection area reference databases on radiation-hazardous facihties, persotmel and equipment of emergency-rescue teams of Rosatom, digital map bank, computer systems for on-hne forecast and measurement of the radiation situation parameters, different data-exchange communication channels, etc. 

Documentation standards should be defined so that there is consistent document layout, style, and reference numbering. Documents should be clearly marked as draft until they are formally released. Version control should be apparent. The version identifiers should distinguish documents under development (drafts) from those that have been issued formally. Documents should include a document history section to log the changes made in successive issued versions of the document. Individual documents should have the following controls ... 

In many circumstances, the supplied system will be based on a standard COTS product and include additional features that are superfluous in the intended context. These features cannot normally be disabled because they are integral to the COTS product. Such redundant features should be included in the Functional Specification, noted as superfluous and, if possible, rendered inaccessible to users within the implemented computer system. Standard features that support compliance, such as audit trails for electronic records, should be used even if not defined within the URS. In such circumstances it may be necessary to make additional design allowances for the inclusion of these features (e.g., for audit trail functionality, extra storage capacity may be required). Standard documentation for COTS products can be referenced by the Fnnctional Specification, if available for inspection, rather than reproduced. Care must be taken to refer to the correct version of COTS documentation and to keep cross-references up to date following any system upgrades. 

In a current developing standards document being considered for the international sterilisation community, under a section on Dosimeters , it is specified that each batch of dosimeters to be used must be properly calibrated. This entails either (1) irradiation of a user s dosimeter in a standards or accredited reference (secondary) laboratory, and subsequent appropriate evaluation by the user, (2) irradiation in a suitably designed irradiation geometry in the user s laboratory along with dosimeters issued by a standards or reference laboratory, or (3) use of a radiation field where the calibration is traceable to a standards laboratory, according to an acceptable accreditation procedure. 

The establishment of reference standards is adopted at the suggestion of the related panels after due consideration of the opinion of the NIHS, which is directly responsible for establishing those reference standards in cooperation with the Society of Japanese Pharmacopoeia. The Society of Japanese Pharmacopeia (Shibuya 2-12-19, Shibuya, Tokyo 150-0002, Japan) is a non-profit private organization that carries out activities in support of MHW administration and regulation of pharmaceuticals. The Society plays several roles and, in particular, makes reference standards available including a part of the pharmacopeial reference standards. It also distributes Pharmacopeia and related informative documents, such as the JP Forum, and convenes public meetings and symposia. 

---