Documentation standards deviation record

On-site measurement of the EIA response with a portable spectrophotometer is useful for documentation, although the response to 1.0 ug/L of atrazine can be visually detected. The results with a laboratory spectrophotometer and a portable hand-held spectrophotometer were compared. Standard curves recorded with these instruments were nearly identical. The standard deviation for 18 replicates were similar with the two instruments (Table II). 

Training and documentation. Responsibilities associated with PV and QA depend on the training of manufacturing personnel and the documentation of their activities. Such activities help to form the recognized quality standard that a pharmaceutical company builds for its products. These personnel are trained to carry out the standard procedures required by GMP documentation includes the write-up/revision of these procedures. Other records document how a batch of product is manufactured, whether unusual incidents or deviations occurred, the existence of reject notices, product complaints, and the investigation and analysis (as needed) of the above abnormalities. 

Suppliers should conduct SCRs on all critical software modules in order to capture deviations from programming standards, identify logic errors, and ensure software modularity. Tailored software developed to satisfy user requirements not catered for within the standard product offering should be a particular focus of attention as the risk of software failure increases for new software developments. SCRs should be documented in order to record observations raised against the software and resultant corrective actions. Further, documented evidence of the implementation of corrective actions should be available for inspection. Where software modules present a major risk to GxP compliance or evidence of internal SCRs is limited, the pharmaceutical organization should consider additional independent reviews. Table 31.12 details the scope and content of programming standards. 

Batch documentation is an important factor. Preparation of master batch records in accordance with plant standard operating procedures (SOPs) should be followed by an approval of the document by the sponsoring division, usually the formulator or process development staff of the R D unit. On completion of a batch, review of the batch records by the quality assurance group ensures compliance to GMP and that all necessary deviations from and modifications to the manufacturing records are properly explained and documented. 

This section requires that all activities in the laboratory must be documented at the time of performance. These approvals and sign-offs shall be documented at time of performance. Any deviations must be recorded and justified. Therefore, all activities from sample set-up, sample pulls, sample testing, etc., are included. It requires that the controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures. 

To avoid any inconsistencies in the final results, one should only deviate from the measurement plan after consultation with the responsible person. All activities of the workers should be recorded and documented in detail as much as possible otherwise the results may not be interpretable. The use of a form as a standardized work description for the documentation of all tasks during a measurement has been proved to be valuable in practice. It should include the person s name. In most cases not every member of a work force can be used for measurements. Therefore it is important to select representative test persons belonging to a similar exposure group. 

IV.60. Documented measures should ensure that tools, gauges, instruments, test software and other inspection, measuring and test equipment, and other devices used in determining conformity to acceptance criteria, are of the proper range, type, accuracy and precision. They should be properly handled and stored, controlled, calibrated and adjusted at specified intervals to maintain accuracy. Records of calibration should be maintained and be adequate for traceability of measurement, to national or international standards, when necessary. When deviations beyond prescribed limits are detected, an evaluation should be made of the validity of previous measurements and tests, and acceptance of tested items reassessed. 

After documentation of critical control points, procedures are laid down for their surveillance (control conditions), permitted tolerances are set, corrective procedures in the event of deviation from these limits decided upon, and responsibility for the maintenance of procedures assigned. After setting and accepting priorities for the enactment of procedures, the status of the conversion is checked by audit. As long as no further need for additional changes is detected, general and standard operation procedures are committed to record. A further audit is then carried out after approximately one year, or in the event of process or product changes. 

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