Stability reports

It is suggested that stability reports include the following information and data to facilitate decisions concerning drug product stability  

source, manufacturing sites, and date of manufacture of drug substance and drug or biological product 

Dosage form and strength, including formulation The application should provide a table of specific formulations under study, and when more than one formulation has been studied, the formulation number is acceptable 

Composition, type, source, size, and adequate description of container and closure stuffers, seals, and desiccants should also be identified 

Specifications and test methodology information Physical, chemical, and microbiological attributes 

---

DEGRAD STABILjcIs Section 1.8.4 The analysis of stability reports often suffers from the fact that the data for each batch of product is scrutinized in isolation, which then results in a see-no-evil attitude if the numerical values are within specifications. The analyst is in a good position to first compare all results gained under one calibration (usually a day s worth of work) irrespective of the products/projects affected, and then also check the performance of the calibration samples against experience, see control charts, Section 1.8.4. In this way, any analytical bias of the day will stand out. For this purpose a change in format from a Time-on-Stability to a Calendar Time depiction is of help. 

Research reports—Research reports such as stability reports, method validation and transfer reports, and pharmaceutical development reports are key documents used for NDA/MAA filings. These documents are strictly version controlled. 

Sandoz stability reports for Parlodel capsules and tablets... 

The effect of constant illumination for 20 hours on a photoelectrode was to reduce the short current photocurrent by 1 %. However the original output was almost restored when the electrode was placed in a fresh solution. The long term stability reported by Modes is encouraging (ll). 

Information available—One batch with three months accelerated stability data reported in a supplement and one batch on long-term stability reported in the annual report. 

One batch on long-term stability reported in annual report. 

I. Chemistry Documentation. Application/compendial product release requirements. Notification of change and submission of updated executed batch records. Stability testing First production batch on long-term stability reported in annual report. 

Active Componeni Characteristics Inactive Component Characteristics Safety Evaluation Product Composition Material Specificai ions Analytical Methods Development Stability Reports... 

Finished Product Test Data Stability Reports Process Validation Report... 

Location of new site and updated batch records none beyond application/compendial release requirements One LT batch on stability report in AR Location of new site and updated batch records Stability Significant body of info available0 One batch 3-mo. acc in suppl. One batch on LT stability in AR Stability Significant body of info not available° Up to three batches with 3-mo. acc in Suppl. Up to three batches on LT stability in AR... 

One batch with accelerated stability reported in CBE. LT stability of first production batch in AR. 

Significant discrepancies between the scheduled test date and the actual analysis date should be explained in the stability report, including the impact of actual analysis dates on the results generated. To ameliorate the consequences of late analysis dates some companies generate stability curves using equations that incorporate the actual analysis dates rather than the scheduled test dates. This should be explained in the stability report. 

The FDA Draft Stability Guidance includes a discussion on the content and format of stability reports. The API stability section is generally straightforward however, the drug product stability section can have many parts and should be especially well organized. In addition to the elements discussed in FDA Draft Stability Guidance, the items included in Example 4 should be considered in order to facilitate review. 

Qualification and maintenance Temperature and humidity records Investigation and reporting of excursions Stability reports Impurities profiles Test points used for data evaluation Selective reporting of data Data trends... 

Coalescence in Porous Media and Emulsion Stability, Report prepared for the U. S. Department of Energy under Contract No. AER-76-14904. 

Chen H., and Allgower, F., A quasi-infinite horizon nonlinear predictive control scheme with guaranteed stability, Report AUT96-28, ETH, http //www.aut.ee.ethz.ch/cgi-bin/ reports.cgi (1996). 

The validation protocol and report may also include copies of the product stability report or its summary as well as validation documentation on cleaning and analytical methods. 

Stability report establishing expiry dating and Process validation protocol for formal three-batch validation of production-size batches. 

Shelf life, stability data stability-indicating assay must be provided, and evidence of product s compliance with specifications during specified shelf-life periods should be shown. Stability reports should include batch sizes and numbers, assay methods used, sampling techniques, conditions of storage and release/stability of each. 

The testing and qualification of reference standards should continue such that the necessary documentation (internal and external reports, certificates of analysis, stability reports, supporting raw data) is complete from both a regulatory and scientific standpoint at the time of the NDA filing. 

Can a stability report be forwarded within one week of being requested ... 

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. 

INTRODUCTION OPERATIONAL ISSUES A. Introduction Protocols Documentation Schedules Stability Reports Audits and Inspections... 

The protocol is the written document that describes the studies to be conducted. The information contained in the protocol will be used to complete the stability report at the end of the study. The information to be included in the protocol is... 

---