Out-of-specification reports

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. 

Samples of intermediates and finished products taken for analysis are recorded, stating the time, date, and conditions for these samples. Deviations in operating conditions and out of specification (OOS) conditions in samples are reported and investigated. Figure 9.2 shows a mechanism for production and in-process controls. 

Summarize the quality data of batches delivered during the last 3 years and prepare trend analysis. Report deviations with regard to normal failure levels, out-of-specification situations, and corrective actions. The quality control and quality assurance managers shall review the trend. 

Federal Regulations This document provides a summary of (and links to) the relevant sections of the Federal Food, Drug, and Cosmetic Act, including 21 Code of Federal Regulations (CFR) part 210 (CMPs for Manufacturing 21 CFR Part 211 (GMS for Finished Pharmaceuticals) and Guidance Documents for NDAs, ANDAs, and Out of Specification (OOS) Test Result Reporting. 

The procurement agency should have a procedure for investigating, handling and reporting out-of-specification results when these are obtained from laboratories. If a sample fails to meet the specifications, the procurement agency should investigate the problem and communicate the outcome to the manufacturer. 

Once the validation is complete, a final report summarizing the acceptability or unacceptability of the cleaning procedures must be written. It should include a summary of the swab, rinse, and air impinger data supporting the adherence to the MAC acceptance criteria and an explanation of any variances or out of specification results. The raw data should be attached to the final report. 

These analytical tests are critical to establish the stability profile of APIs and drug products. These tests require a level of expertise and attention to detail that an experienced analyst needs. A training program is critical to ensure that the analyst understands the tests as well as recognizes the atypical or out-of-specification results. Proper reporting of results is also crucial for these procedures as some of them are subjective. 

Chapter 13 discusses the collection and presentation of stability data. Evaluation of data (ICH QIE) is also discussed as well as Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations. In addition, it also introduces the stability report and data trending. 

The correctly designed, computer-based LIMS will offer a more robust and accurate means of identifying out-of-specification results than can be achieved by a human laboratory technician. With the additional ability to trend, collate and report results, the LIMS has become an important tool within the laboratory environment. The integrity of the data is frequently scrutinized by the regulatory authorities and is often found to be an area of weakness. 

The cells of reporting and communications, analytical decision-making, and organizational integration cover the functions whereby reports generated by the system are transmitted via the network, out-of-specification results are highlighted, and the cH-ents can have remote access for online query of the database. The aim of these first two cells is to transmit the report to the client effectively and highlight aberrant results this allows the client to focus immediately on problem areas. Some of the options available to implement this section are covered in more detail under Financial justification and risk assessment in the next section. 

---