What is retest period in stability?
What is retest period in stability?
Retest period: The period of time during which the drug substance is expected to remain within its specification and, therefore, can be used in the manufacture of a given drug product, provided that the drug substance has been stored under the defined conditions.
What is the difference between retest period and shelf life?
“Retest date for drug substances – if you have a drum of this product, you would test it periodically (every six months) and on the basis of the test results, you would recertify it for use for another six months. Expiration date – once this is reached, the entire drum has to be discarded.
What is ICH q1 guideline?
Guideline. Q1B Guideline. Q1CStability Testing for New Dosage Forms. The ICH Harmonised Guideline was finalised under Step 4 in November 1996. It extends the main stability Guideline for new formulations of already approved medicines, and defines the circumstances under which reduced stability data can be accepted.
Which guideline means evaluation of stability data?
Regression analysis is considered an appropriate approach to evaluating the stability data for a quantitative attribute and establishing a retest period or shelf life.
How do you calculate retest date?
The retest date shall be calculated from the date of manufacture of the material if available. For raw materials and excipients where a date of manufacture is not available from the supplier, the date of testing or date of release on the Certificate of Analysis may be used.
Can we use expired API after retest?
Yes you can. However a retest is needed and “new expiring date” will be determined by the forced degradation studies of your API. This question has been addressed in Q7 Q&A in section 14.2. “According to the definition, material should not be used after the expiry date.
What is Q1A R2?
FDA Guidance for Industry: Q1A(R2)Stability Testing of New Drug Substances and Products. This revised ICH guidelines regulate the scope necessary for marketing authorization of the stability testing of new active substances and finished medicinal products containing new active substances.
What is real time stability?
In real-time stability testing, a product is stored at recommended storage conditions and monitored until it fails product specifications. In accelerated stability testing, a product is stored at elevated stress conditions (e.g., high temperatures and/or humidity).
How shelf life is calculated?
Shelf life is determined by the evaluation of whole stability data of the product. When the statistical calculations cannot be done by the data, the shelf life period can be defined 1.5 times of the period covered by the long-term data.
What is ICH testing?
ICH Stability Studies: Storage and Testing Services. Gathering pharmaceutical stability testing data on drug products or drug substances to determine an overall stability profile is a necessary step in the drug approval process.
How do you determine the shelf life of a drug?
If long-term condition or accelerated condition data shows change then statistical analysis is used to estimate the shelf-life of the drug product. When the statistical calculations cannot be done by the data, the shelf life period can be defined 1.5 times of the period covered by the long-term data.
What is the retest period?
What is retest period? The retest period is the timeframe during which the Drug Substance / Active Pharmaceutical Ingredient (API) can be considered to remain within the predefined specification and therefore, acceptable for use. After this period, the API should be retested for compliance with specifications before use.
When to consider extrapolation when proposing a retest period or shelf life?
This guidance describes when and how extrapolation can be considered when proposing a retest period for a drug substance or a shelf life for a drug product that extends beyond the period covered by available data from the stability study under the long-term storage condition (long-term data).
When is the retest date assigned to a drug product?
The retest date is assigned during product design, at the time of initial production, or at a stability testing interval. Secondly, how do you determine the shelf life of a drug product?
What is the difference between expiration date and retest date?
The Expiration Date defines the total shelf life of the product. Retest dates are assigned to new products and to products which are continuing on stability testing. The retest date is assigned during product design, at the time of initial production, or at a stability testing interval.
