PHARMACEUTICS STABILITY

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m pharm stability with guideline Q1 R2

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SEMINOR ON CONCEPT AND OBJECTIVE OF STABILITY PRESENTED BY:- MAHAJAN PRITEE SANJAY R.G.SAPKAL COLLEGE OF PHARMACY. DEPARTMENT-: PHARMACEUTICS

DEFINITION :

DEFINITION The capacity of a drug or product to remain within established specification of Identity , Q uality , Purity in a specific period of time. STABILITY STABILITY is officially defined as the time lapse(period) during which drug substance (API) or drug product to retains the same properties and characteristics(i.e . Physical, Chemical, Microbiological, Therapeutic and Toxicological specifications to maintain its identity, strength, quality, and purity) that it possessed at the time of manufacture.

NEED FOR STABILITY TESTING:

NEED FOR STABILITY TESTING H ow the quality of drug product varies with time. Establish shelf life for the drug product. Determine recommended storage conditions. Determine container closure system suitability . Safety point of view of patient.

Objectives of STABILITY TESTING:

O bjectives of STABILITY TESTING For patients ’ welfare. To protect the reputation of the producer. Requirements of regulatory agencies. To provide a database that may be of value in the formulation of other products. Shelf-life & storage condition and labeling specification.

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Adequate formulation & container closer systems. How quality of drug substance or product varies with the time under the influence of various factors. Degradation product & possible degradation pathway. Prevent great loss by recalling the batch due to stability.

Types of STABILITY studies:

Types of STABILITY studies Stability studies are classified into three types, based the temperature and humidity employed during the studies. T hese are:- Accelerated stability testing intermediate testing Long term testing

Types of STABILITY studies:

Types of STABILITY studies ICH Q1A(R2 ) ICH Q1B ICH Q1C ICH Q1D ICH Q1E ICH Q1F Photo stability testing of new drug substances & products. Stability testing of dosage forms. Bracketing & matrixing design for stability testing of new drug substance & products. Evaluation of stability data. Stability data package for the registration applications of the climate zones III & IV. Stability testing of new drug substances & products.

Stress testing:

Stress testing These guidelines help to identify the likely degradation product to establish the degradation pathway and intrinsic stability of the molecule . Selection of batches At least 3 primary batches of the drug substance should be selected. The quality should be representative to quality of material used for production scale.

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Container closure system Specification: -list of tests -reference to analytical procedure -proposed acceptance criteria Test attributes: -Attributes that are susceptible to changed storage, Influence quality, safety and/or efficacy Should cover and microbiological attributes.

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Testing frequency Type of study Testing Type equation here. frequency Long term studies For drug sub. With a proposed re test period of atleast 12 months. 1 st year……….3months 2 nd ……………..6month There after…… annualy Through the proposed re-test period Accelerated studies Min. 3 time points(0,3,6 months),from a 6-month study Intermediate studies Min. 4 time points (0,6,9,12 months),for a 12month study. Type of study Long term studies For drug sub. With a proposed re test period of atleast 12 months. 1 st year……….3months 2 nd ……………..6month There after…… annualy Through the proposed re-test period Accelerated studies Min. 3 time points(0,3,6 months),from a 6-month study Intermediate studies Min. 4 time points (0,6,9,12 months),for a 12month study.

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Storage conditions Drug products - General case Study Storage condition Minimum time period covered by data at submission Long term 25°C ± 2°C / 60% ± 5% R.H or 30°C ± 2°C / 65% ± 5% R.H. 12 months Intermediate 30°C ± 2°C / 65% ± 5% R.H. 6 months Accelerated 40°C ± 2°C / 75% ± 5% R.H. 6 months

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Drug packaged in semi permeable containers-:

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Study Storage condition Minimum time period covered by data at submission Long term 5°C ± 3°C 12 months Accelerated 25°C ± 2°C / 60% ± 5% R.H. 6 months D rug substances intended for storage in refrigerator

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Drug substances/Product- intended for storage in Freezer Study Storage condition Minimum time period covered by data at submission Long term -20°C ± 5°C 12 months

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Stability commitment Stability commitment is the commitment to the customer or regualtory authorities saying that stability studies are continued till the long term data covered the proposed retest period. Long term stability data do not cover proposed re test period granted at time of approval,commitment should be made to continue post approval to establish re-test period. Not required for submission which includes data from 3 production batches, commitment to continue through proposed re-test period.

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Fewer than three production batchs commitment continue with these studies through proposed re-test period and place additional production batches to a total of three on long term stability through proposed re-test period No production batches commitment to place first three production batches on long term stability studies through proposed re-test period .

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The purpose of stability is to establish re-test period(DS) & shelf life (DP) for future batches based on evaluation of results obtained from chemical , physical , biological , microbiological tests. A systemic approach should be adopted in the presentation & evaluation of the stability information which covers the physical ,chemical & biological parameter . Evaluation

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A minimum of 3 batches of drug product was tested. The analyst must found the batch to batch variability & if it is small then only it is accepted & can be done by different statistical tests . Any evaluation also consider the not only the assay but also consider the other parameter testing and also the different stability and degradation performance .

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A storage statement should be established based on the stability evaluation of the drug substance Term such as “ambient condition “ or room temperature” should be avoided. Re-test data should be display on the container label if appropriate. Statement /labelling

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DEFINATION A method by which a product is exposed to elevated temperature simulating what would happen over longer period on the shelf life. WHY? The stability of pharmaceutical preparations should be evaluated by exposing the product to normal shelf conditions for a year or extended periods. The rate of decomposition is slow at room temperature .Such a method is time consuming and uneconomical. ACCELERATED STABILITY STUDY

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OBJECTIVES: To predict the shelf life of a pharmaceutical product by accelerating the rate of decomposition ,preferably by increasing the temperature.

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CONCLUSION

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