requirement to put stability on patient results report

How to report on stability study results?

Reporting of Stability Study results : The analyst shall analyze the samples as per the test procedures given in the stability study Template. On completion of the analysis of all the tests, the analyst shall enter the results LIMS as well as in the Stability study summary report.

What are the requirements for stability assessment?

• Stability assessment should cover all relevant conditions encountered in practice A  • Storage duration should be at least equal to the maximum storage period for any individual study sample A  • Deviation of the result for a stored sample from the reference value should not exceed 15% (chromatography) or 20% (binding assays) S/L

When samples should not be kept for stability studies?

Any batch packed later or samples are provided after three months from the date of manufacturing then the samples should not be kept for stability studies. The stability coordinate shall draw the samples of the due product station from the respective chamber in a specified quantity at the time of analysis. Also read =>SOP for Vendor Management

When should I update the stability study protocol?

Whenever specification is updated for any reason (like pharmacopoeial change but not limited to) and causes a change in analytical method, acceptance criteria, test inclusion/deletion, etc. update the associated Stability Study Protocol which shows the required changes e.g. specification No., acceptance criteria, etc.

What are the rules for stability testing?

The stability testing should cover chemical, physical, biological and microbiological attributes including preservative content and the testing of those attributes of the drug products that are susceptible to change during storage and are likely to influence quality, safety and or efficacy of the drug product.

WHO guidelines for stability testing is for?

The Committee discussed and adopted the recommended modification of storage conditions published in the WHO guidelines for stability testing of pharmaceutical products containing well-established drug substances in conventional dosage forms to read 30°C (± 2°C) and 65% (± 5%) RH for real-time stability studies destined ...

Why stability study is required?

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug ...

What are stability indicating parameters?

A Stability-indicating assay method can be defined as “Validated quantitative analytical method that can detect the change with time in the chemical, physical or microbiological properties of the drug substance and drug products are specific so that the content of active ingredients and degradation products can be ...

Which guideline stands for evaluation of stability data?

2.6 General Statistical Approaches Regression analysis is considered an appropriate approach to evaluating the stability data for a quantitative attribute and establishing a retest period or shelf life.

What is stability testing?

Stability Testing is the process for determining, through storage at defined conditions and testing at specific intervals, how long a drug substance or product remains safe and effective at particular storage conditions.

What is a stability protocol?

The stability test protocol should define the test parameters that would be used for evaluation of the stability samples. The tests that monitor the quality, purity, potency, and identity which could be expected to change upon storage are chosen as stability tests.

What are the three types of stability studies?

Types of Drug stability studies: – Stability studies are mainly of following types:Long term stability.Intermediate stability.Accelerated stability.In-use stability.

How do you conduct a stability study?

7 Steps for Stability TestingStep 1: Batch Production. ... Step 2: Product Container Filling. ... Step 3: Initial Test (Time Point Zero). ... Step 4: Product Storage. ... Step 5: Product Evaluation. ... Step 6: Determine Stability. ... Step 7: Conclusion Report.

What are the stability conditions?

The essence of stability condition is that the error introduced into the approximate solution by a particular difference method remains uniformly bounded as n→∞ with n as the solution time step.

What is stability in method validation?

According to FDA guidelines (Guidance for Industry, Analytical Procedures and Methods Validation, FDA, 2000), a Stability Indicating Method (SIM) is defined as a validated analytical peptide testing procedure that accurately and precisely measure active ingredients (drug substance or drug product) free from process ...

What is significant change in stability?

A significant change instability is a deviation from its trend. According to ICH guidelines, the remarkable changes observed in the drug product considered significant changes.

How to store stability study results?

Store all the stability study results along with the associated documents with a sample test form, chromatogram, and other relevant documents.

When should samples be incubated for all stability conditions?

Samples for all stability conditions shall be incubated on the same date in all respective Stability chambers.

How much does the total additive effect of all excipients change?

The total additive effect of all excipients changes shall not vary by more than 10%.

How are ICH samples kept?

These samples are kept in different temperatures and relative humidity condition chambers/incubators as per recommendations based on the ICH guidelines and or the specific Stability Study Protocols.

What is long term condition testing?

Long Term condition testing: Stability studies under the recommended storage condition for the proposed or approved shelf life for labeling.

Who makes an entry in the template/protocol issue register?

Stability Coordinator or Designee shall make an entry in the Template/Protocol Issuance Register” as per SOP.

Who selects batches for stability studies?

The quality assurance shall select the batches for stability studies.

What happens if the test results for these samples fall within the manufacturer's stated acceptable limits?

If test results for these samples fall within the manufacturer’s stated acceptable limits, accuracy is verified.

What happens if a lab test is not accurate?

Conversely, if the study results indicate that the test is not accurate or results cannot be consistently reproduced, the laboratory’s Technical Consultant/ Technical Supervisor and the test system manufacturer should be consulted regarding steps to resolve the problem.

How to verify manufacturer's test range?

To verify the manufacturer’s established reportable range for the test, choose samples (e.g. previously reported patient or proficiency testing samples with abnormal high and abnormal low values, QC materials, or calibration materials) with known values at the highest and lowest levels the manufacturer claims accurate results can be produced by the test system. The laboratory may only report patient test results that fall within the verified levels. The Laboratory Director and/or the Technical consultant/Technical supervisor will need to decide how the laboratory will report results that are greater than the highest verified level or less than the lowest verified level.

Who is responsible for verifying performance specifications?

The Technical Consultant/Technical Supervisor or Laboratory Director are responsible for ensuring the procedure used for verifying the performance specifications is adequate, as well as evaluating the results generated during the verification process. The test system manufacturer may also assist by providing a verification procedure and appropriate samples for the evaluation. However, the verification procedure must be approved by the Laboratory Director and the laboratory staff must participate in the verification process. The manufacturer may assist the laboratory with performing this activity; however, the laboratory must perform the verification of the test system performance specifications.

Who is responsible for determining the appropriate number of samples for a verification study?

Depending on the test system and the laboratory’s testing volume, the actual number of specimens needed for each part of the verification study may vary. The Laboratory Director and Technical Consultant/Technical Supervisor are responsible for determining the appropriate number of samples.

What is the purpose of CLIA?

NOTE: Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing authority to promulgate standards for certain laboratory testing to ensure the accuracy, reliability and timeliness of test results regardless of where or by whom the test was performed . The CLIA requirements are based on the complexity of the test and the type of laboratory where the testing is performed. While every effort has been made to ensure the accuracy of this restatement, this brochure is not a legal document. The official CLIA program requirements are contained in the relevant law, regulations and rulings. Please note that state, local, and accreditation requirements may be more stringent.

Why did the obstetrician not tell the patient to go to the hospital?

A few days after discharge from the hospital, the patient called her obstetrician to report she had vaginal bleeding and a fever. He testified he advised her to go to the hospital, but she could not do so due to child care issues.

Does the Joint Commission require critical test results?

The Joint Commission requires staff to report critical test results; this is a National Patient Safety Goal. But critical test results go beyond this concept. Consider this case.

What is the absence of a written protocol for stability testing?

The absence of a written protocol for stability testing is cause to initiate regulatory action against the product and/or the responsible firm.

How often should you do stability testing?

It is commonly recommended that stability testing be performed initially, than every three months for the first year, then every six months for the second year, and then annually thereafter.

What is 21 CFR Part 211?

Publishing of 21 CFR Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals established requirements concerning the expiration date on a drug product and stability testing to assure the appropriateness of that date. Each drug product may be a unique article because of, for instance, differences in (1) chemical and physical properties of the active ingredients or the excipients, (2) manufacturing procedures, (3) formulations, (4) containers and closures, (5) proposed storage conditions, and (6) the stability of the article to maintain its quality or purity through the use of antioxidants or preservatives. Because of the uniqueness of each drug product, it is virtually impossible to provide one set of rules that can apply to all situations. The CGMPs were purposely written broadly to allow for such unique differences.

Why should preservatives be monitored?

Products formulated to contain preservatives to inhibit microbial growth should be monitored throughout their shelf life to assure the effectiveness of the preservative system. Once a minimally effective level of preservative is established, chemical testing for the preservative (s) may be performed.

When should sterility testing be performed?

When qualifying the container-closure system, sterility testing should be performed initially and at the end of the expiration dating period.

Do USP monographs have stability indicating tests?

While many USP tests are specific for the drug or its degradates and may be used for stability testing, some USP monographs do not incorporate stability indicating tests. Additionally, it may be unreasonable to expect a manufacturer to develop specific methodology for each component of some multi-component drugs containing ingredients of botanical origin such as benzoin, Peruvian balsam or tolu balsam.

Where should a sample be stored?

Samples should be stored at room temperature; an additional sample stored at elevated temperatures or under other stress conditions may be used if it is appropriate to do so.

What is the first factor used in determining the stability data package recommendation?

The first factor used in determining the stability data package recommendation is whether or not the protective properties of the container/closure system are affected by the proposed change.

What should be included in a drug specification?

The specification for a new drug product should include a list of degradation products expected to occur during manufacture of the commercial product and under recommended storage conditions.

What should be provided in the registration application for all relevant batches of the new drug product used for clinical, safety, and?

Analytical results should be provided in the registration application for all relevant batches of the new drug product used for clinical, safety, and stability testing, as well as batches that are representative of the proposed commercial process.

What should be examined at the end of the exposure period?

At the end of the exposure period, the samples should be examined for any changes in physical properties (e.g., appearance, clarity, or color of solution) and for assay and degradants by a method suitably validated for products likely to arise from photochemical degradation processes.

What is the process of acquiring and evaluating data that establishes the biological safety of an individual degradation product?

Qualification is the process of acquiring and evaluating data that establishes the biological safety of an individual degradation product or a given degradation profile at the level(s) specified.