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Archive of SOPs - Stability Summaries

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S-005-01-2016 - - Indexing procedure for Stability Studies.
The purpose of this standard operating procedure is to establish an index and an annual supplementary index for stability study SOPs. The supplementary index allows for new SOPs or updated existing SOPs to be indexed in the supplement and distributed in real time.

S-010-01-2016 Index for Stability Studies.
The purpose of this standard operating procedure is to index the Stability SOPs as shown above.

S-015-01-2016 Initiating a Stability Study.
The purpose of this standard operating procedure is to define the stages and documentation required in order to start or initiate a development, pivotal, or commercial stability study.

S-020-01-2016 Contents of a Stability Protocol.
The purpose of this standard operating procedure is to define the parameters needed in the stability protocol that meet the specific FDA regulatory requirements.

S-025-01-2016 Setting limits for check specifications in a Stability Study.
The purpose of this standard operating procedure is to establish the development procedures for setting upper and lower specification limits for the release and stability (check) specifications for a Stability Study.

S-030-01-2016 Number and size of batches for stability testing.
The purpose of this standard operating procedure is to establish the procedure for determining the number and sizes of batches commonly required from development to commercial batch, stability study purposes. This SOP is specific for topical semi-solid and topical liquid ANDA products.

S-035-01-2016 Number of samples required for performing stability tests.
The purpose of this standard operating procedure is to establish the number of samples required for performing the analytical tests in a Stability Study. This SOP is specific for each dosage form under evaluation.

S-040-01-2016 Storage configuration of samples in a stability environment.
The purpose of this standard operating procedure is to determine the storage configuration of the stability samples in the climatic controlled rooms or chambers during the course of the stability study.

S-045-01-2016 Stress testing the bulk drug substance for stability analysis.
The purpose of this standard operating procedure is to determine the stress testing procedures and parameters for an approved supplier of the active drug substance. The data is used for impurity evaluation and method validation.

S-050-01-2016 Intervals and climatic and storage conditions for a US development Stability Study.
The purpose of this standard operating procedure is to define the intervals and storage conditions for conducting formulation stability studies intended for ANDA/OTC formulations for US approval.

S-055-01-2016 Intervals and climatic conditions for a US Pivotal /Bioequivalence Stability Study.
The purpose of this standard operating procedure is to define the intervals and storage conditions for conducting Pivotal stability studies intended for ANDA/OTC formulations for US approval.

S-060-01-2016 Intervals and climatic conditions for a US validation/PM Stability Study.
The purpose of this standard operating procedure is to define the intervals and storage conditions for conducting Validation and Post Marketing stability studies intended for ANDA / OTC formulations for US approval.

S-065-01-2016 Placing the Reference Listed Drug (RLB) on Stability.
The purpose of this standard operating procedure is to establish the procedure for placing the reference listed drug on stability studies in order to evaluate the RLD's analytical parameters and impurity profile at different time intervals.

S-070-01-2016 Determining the 'Due dates' for a Stability Study protocol.
The purpose of this standard operating procedure is to determine the 'due dates' (individual testing stations) at which samples are taken from the controlled storage environment for the purpose of analytical testing according to the stability protocol.

S-075-01-2016 Setting the 'Start date' for a Stability Study.
The purpose of this standard operating procedure is to determine the 'start dates' at which samples are placed in controlled climatic condition according to the stability protocol. This procedure determines the time limitations between each step in the procedure.

S-080-01-2016 The initial Certificate of Analysis at To for a Stability Study.
The purpose of this standard operating procedure is to initiate appropriate time frames for starting a Stability Study not later than 30 days, after the sample has been fully QC tested and a regulatory valid certificate of analysis (C-of-A at time zero (To)) has been issued.

S-085-01-2016 Packaging procedures on Formulation lots for a stability study.
The purpose of this standard operating procedure is to determine the packaging procedures and quality control functions on development formulation lots for a Stability Study. The number of units packed and the sampling protocol is clearly established.

S-090-01-2016 Packaging procedures on the Process Qualification Batch for a stability study.
The purpose of this standard operating procedure is to determine the packaging procedures and quality control functions on the final process qualification lots for a Stability Study. The number of units packed and the sample protocol is clearly established.

S-095-01-2016 Representative sampling procedures during batch packaging of stability samples.
The purpose of this standard operating procedure is to define the sampling protocol used during packaging procedures in order to accomplish a fully representative sampling operation of the entire batch.

S-100-01-2016 Container-Liner-Closure systems for a Stability Study.
The purpose of this standard operating procedure is to specify the container-closure-liner parameters required for product testing from product development to the process qualification stage and the final validation/commercial lots.

S-105-01-2016 Certification of a Container -Liner-Closure System.
The purpose of this standard operating procedure is to establish the vendor and in-house documentation requirements in order to meet the FDA documentation filing requirements for container-liner-closure systems. The contents of each document is briefly described.

S-000-01-2016 Labeling of Stability Study Samples.
The purpose of this standard operating procedure is to specify the procedure and exact label data requirements for labeling stability study samples.

S-115-01-2016 Storing the stability study samples under controlled conditions prior to analysis.
The purpose of this standard operating procedure is to establish the storage conditions under which stability samples are kept during the interim period between the sample "due date" and the time prior to laboratory analysis to prevent sample spoilage.

S-120-01-2016 Reporting test results of a Stability Study.
The purpose of this standard operating procedure is to determine the procedure for reporting and recording of the stability test results at each test interval in the analytical laboratory. The procedure for averaging, reviewing and distributing the test results are documented.

S-125-01-2016 Procedures for handling abnormal or OOS results in a Stability Study.
The purpose of this standard operating procedure is to establish the procedure for investigation into abnormal assay fluctuations or out-of-specification (OOS) results in the analytical and microbiological stability program testing.

S-130-01-2016 The control of Analytical methods #'s and Edition #'s in stability documentation.
The purpose of this standard operating procedure is to ensure that the correct analytical methods numbers and edition numbers are used in the analytical and microbiological testing laboratory, and are specified in the stability documentation during the course of a Stability Study. This SOP insures that method changes are updated in the stability documentation.

S-135-01-2016 Cross-referencing laboratory notebooks with computerized stability documentation.
The purpose of this standard operating procedure is to cross-reference laboratory analytical and microbiological notebooks containing the raw data at each specific test interval with the computerized stability documentation.

S-145-01-2016 Auditing stability data in laboratory notebooks.
The purpose of this standard operating procedure is to determine the method of auditing the stability testing raw data in the laboratory notebooks (analytical and microbiological) and to ensure the precise computerization of the stability data reports.

S-150-01-2016 Recording stability study climatic conditions.
The purpose of this standard operating procedure is to ensure the correct recording procedures, of temperature and humidity control charts for the climatic chambers or controlled environment rooms. Breakdown procedures of chart recorders and corrective action are documented

S-155-01-2016 Review and control of temperature and humidity recording charts.
The purpose of this standard operating procedure is to ensure the correct review, audit and record keeping of temperature and humidity control charts for a climatic chambers or controlled environment rooms.

S-160-01-0696 Periodic revalidation of climatic rooms and chambers.
The purpose of this standard operating procedure is to ensure the periodic revalidation of the climatic rooms and chambers to secure that the temperature and humidity is within limits at all points where samples are stored in the controlled area.

S-170-01-2016 Sanitation and housekeeping requirements of climatic chambers.
The purpose of this standard operating procedure is to specify appropriate sanitation and housekeeping practices, conditions and requirements of climatic chambers and controlled environment rooms.

S-175-01-2016 Fault correcting procedures (after breakdowns) during a Stability Study.
The purpose of this standard operating procedure is to determine the procedures to follow after a breakdown or failure of the equipment or power supply during an ongoing stability study. The use of hand thermometers and recording logbooks and the corrective action procedure is documented.

S-180-01-2016 Emergency procedures during a Stability Study.
The purpose of this standard operating procedure is to is to determine the procedures to follow after a permanent breakdown or failure of the climatic chambers equipment (motor burnout/probe failure) during an ongoing stability study. Corrective action procedures are documented.

S-185-01-2016 Reserved.
The purpose of this standard operating procedure is to identify specific in-house SOPs due to unique conditions, methods or equipment operating within the company.

S-190-01-2016 Conditions for stopping a Stability Study.
The purpose of this standard operating procedure is to define the precise conditions subject to which an ongoing stability study will be terminated.

S-200-01-2016 The layout and format of a regulatory stability report (the filed FDA report)
The purpose of this standard operating procedure is to define the contents and data fields as well as the document layout and format of a regulatory stability report ready for filing with an FDA agency.

S-210-01-2016 Self inspection procedures in a stability department.
The purpose of this standard operating procedure is to provide for self inspection procedures according to the written in-house compliance program specific for the stability department.

S-220-01-2016 Using stability SOPs and compliance program as stability training tools.
The purpose of this standard operating procedure is to highlight the training tools established in order that appropriate training procedures are provided to the departmental personnel with specific respect to standard operating procedures and in-house compliance programs.

S-225-01-2016 The Do's and Don'ts of a Stability Study - a departmental training tool.
The purpose of this standard operating procedure is to document a check list for departmental training purposes of common practice to follow and to avoid when performing stability studies.

S-230-01-2016 Stability department compliance staff training.
The purpose of this standard operating procedure is to provide specific written GMP, SOP, Compliance and stability documentation, specific training programs for the stability department personnel.

S-235-01-2016 Documentation requirements for a Stability Study - contents of a Stability Dossier.
The purpose of this standard operating procedure is to provide a check list of all the documentation and forms required to make up the complete contents of a Stability Study dossier.

S-240-01-2016 Job description of stability department personnel.
The purpose of this standard operating procedure is to document and provide appropriate job descriptions for the personnel in the stability department or involved in the performance of stability functions.

S-245-01-2016 Review and auditing stability study documentation.
The purpose of this standard operating procedure is to review and audit each stability study in order to ensure that all documentation from laboratory Notebooks to computerized stability reports are accurate and complete.

S-250-01-2016 Accepting and Signing-off a Completed Stability Study.
The purpose of this standard operating procedure is to specify the acceptance and signing-off procedure for a completed stability study to ensure that the study is complete.

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