Deviation report documentation

The requirement to assure that deviations reported by the QAU are communicated to the study director and that corrective actions are taken and documented does not mean that management itself must communicate the findings and take appropriate corrective action. An efficient QAU will document deviations and the fact that corrective action has already occurred in reports that are distributed to both management and the study director. The need for additional management follow-up will then be necessary only in those few instances in which corrective action was not adequately negotiated between the QAU and the scientific staff before the issuance of the QAU report. When corrective action is un-... 

Responsibilities and data collection procedures Test procedures, specific acceptance criteria Documentation procedures Summary and deviation report... 

In the event that the CIP procedure does not proceed in accordance with the validated procedure, a deviation report and investigation would need to occur. Unfortunately, documentation associated with deviations, pharmaceutical exceptions, and failures is often not handled with the extent of detail and urgency required by regulatory agencies. 

Memos, master production and control records, SOPs, deviation reports, validation protocols, manual batch documentation, and many more. 

Test attributes procedures and acceptance criteria selection of batches testing frequency storage containers, conditions, and period, as well as data evaluation are discussed in great detail. Data evaluation considers out-of-specification results. Documentation covers protocols and protocol amendments, deviation reports, out-of-specification reports, test results and raw data, and stability reports. 

In the course of doing product development work, there are instances in which it is not possible to follow the written procedures. This may happen in the manufacture of the batch, in use of an analytical method an SOP that needs to be revised, or for other possible reasons. Just as the protocol has an amendment mechanism to document changes to the plan, the use of a formal deviation report mechanism allows studies to be continued and any deviations to be documented with the reason and the appropriate corrective action, if needed. The report should list the deviation, why it occurred, who agreed to it, any corrective action plan, and signatures of the person initiating the report and management s agreement. 

A procedure should be documented and established for the review of Deviation Reports (see Other Supportive Documents—Clause 558) and other indicators of quality or procedural problems. The procedure should require analysis of the data, assessment of whether a significant problem exists and allocation of the task(s) for corrective action. 

The phase behaviours of binary and ternary ionic liquid mixtures with carbon dioxide,organics " and water " have been determined using COSMO-RS. In the COSMO-RS framework, ionic liquids are considered to be completely dissociated into cations and anions. Ionic liquids are thus taken as an equimolar mixture of two distinct ions, which contribute as two different compounds. Because ionic liquids only dissociate in the presence of strongly polar substances, the COSMO-RS prediction of the phase behaviour of ionic liquid systems with polar compounds (water and alcohols) is more accurate than that of ionic liquid systems with nonpolar compounds (carbon dioxide and organics). Especially the COSMO-RS prediciton of the solubility of (relatively nonpolar) carbon dioxide in ionic liquids shows considerable deviations ( 15 %) from experimental values. lUPAC Technical Reports document the measurements of the thermodynamic and thermophysical properties of l-hexyl-3-methylimidazolium bis [(trifluoromethyl)sulfonyl]amide and the recommended values. ... 

The GLP standards identify three types of deviations there are deviations from GLP standards, from the protocol, and from SOPs. Any deviation must be reported to the Study Director and documented in the raw data notebook. There are differences in the reporting process for the types of deviations. 

All foam systems should be thoroughly inspected and checked for proper operation at least annually. The inspection should include performance evaluation of the foam concentrate or premix solution quantity or both. Test results that deviate more than 10% from those recorded in acceptance testing should be discussed immediately with the manufacturer. The inspection report should be documented with any deficiencies or recommendations included. Foam system inspections should include ... 

If deviations from a protocol are intended to be permanent, a protocol amendment should be issued to document the change. If a deviation from the protocol is an error, the deviation should be promptly corrected and should be documented in the study records and described in the final report. 

Good Laboratory Practice deviations that were of a continuing nature throughout the course of a study will require a conforming amendments statement of the reason for the noncompliance. One-time deviations from GLP requirements should be documented in study records and should be described in the final report but will not require a conforming amendments statement of the reason for the noncomphance. 

Laboratory management is responsible to assure that deviations from the GALP standards are reported and that corrective actions are taken and documented. 

To assure that any deviations from the GLP standards reported by the QA unit are communicated to the study director and corrective actions are taken and documented... 

The protocols define procedures to be used to verify the performance of qualified equipment. As part of validation, the results obtained should be carefully recorded and compared with the design conditions. Deviations or diversions contrary to the specified levels determine the suitability of the controlled environment, so the reporting form represents the document for certification or acceptance of the system. The reporting form should show the following information ... 

A validation report is a written document that cross-references the validation protocol, summarizes the results obtained, describes any deviations observed, and draws the necessary conclusions, including recommending changes required to correct deficiencies for the qualification and validation performed [5]. In this report it is required to present both the results and conclusions and the secure approval of the study. The report should include a summary of the procedures used to clean, sample, and test as well as the physical and analytical test results or references for the same. The conclusions regarding the acceptability of the results should also be included. Other information would be the status of the procedures being validated, any recommendations based on the results, or any relevant information obtained during the study. These include, re validation practices (if applicable), the approved conclusions, and any deviations of the protocol that might have occurred. In cases where it is unlikely that further batches of the product will be manufactured for a period... 

The bioanalytical laboratory should have a written set of standard operating procedures (SOPs) to ensure a complete system of quality control and assurance. The SOPs should cover all aspects of analysis from the time the sample is collected and reaches the laboratory until the results of the analysis are reported. All deviations from SOPs must be authorized by the study director and documented in the raw data. Significant changes in established SOPs must be properly authorized in writing by management. 

How do you prepare for an audit of the environmental chambers In preparing for an audit, it is necessary that all validation documents be readily available for inspection. If these documents are stored off-site, arrangements should be made to retrieve these documents in time for the inspection. In addition, all chamber deviations should be identified and summarized in an annual report, if necessary. Also, the chamber inventory should be verified against existing records to ensure accuracy. An explanation should be available to explain any inventory discrepancies. 

The report may follow the same format as the validation plan to aid cross-reference and must review all the key validation life-cycle documents. Any deviations and associated corrective actions should be reviewed, and any concessions on the acceptability of qualification test results examined. 

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