ICH Guidelines for stability testing PPT by amol m. sabale

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ICH GUIDELINES FOR STABILITY TESTING Presented by: Mr. Amol M. Sabale (M.Pharm SEM-II ) Department of Pharmaceutics Supervised by : Dr . John I. Disouza Principal Guided by : Ms. Sanjeevani R. Desai Asst. Professor Department of Pharmaceutics Tatyasaheb Kore College of Pharmacy, Warananagar

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10/12/2012 2 Seminar Outline: Introduction ICH guidelines ICH Q1A (R) ICH Q1B ICH Q1C ICH Q1D References TKCP,Warananagar

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Stability: Stability of pharmaceutical product may be defined as the capability of a particular formulation in a specific container/closure system to remain within its physical, chemical, microbiological, therapeutic and toxicological specification. Types stability studies: 1) Long term stability study 2) Intermediate stability study 3) Accelerated stability study Introduction : 10/12/2012 3 TKCP,Warananagar

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Drug & excipients Formulation Environment Factors Affecting Drug Stability 10/12/2012 4 TKCP,Warananagar

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Provide evidence as to how the quality of the 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 Prevention of economical repercussion Essential quality attribute Need for stability testing: 10/12/2012 5 TKCP,Warananagar

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Organizations regulating stability guidelines 10/12/2012 6 TKCP,Warananagar

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The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry Mission: 1) To achieve greater harmonization . 2) To ensure that safe, effective and high quality medicines are produced and registered in the most efficient manner. ICH Products: Quality guidelines Efficacy guidelines Safety guidelines Multi disciplinary guidelines 10/12/2012 7 TKCP,Warananagar

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10/12/2012 8 uality guidelines TKCP,Warananagar

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The ICH Q1 series of guidelines are designed for stability programs. The ICH Q1 topic on stability testing is covered by 6 separate guidelines. Stability testing Guidelines 10/12/2012 9 TKCP,Warananagar

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Temperate Zone KMT-21˚C RH-45% Mediterian zone KMT-25˚C RH-60% Tropical Zone KMT-30˚C RH-35% Desert Zone KMT-30˚C RH-70% Zone concept 10/12/2012 10 TKCP,Warananagar

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Climatic Zone Countries Temp. ˚C Humidity %RH Climatic zone I (Temperate) Japan, United Kingdom, Northern Europe, Canada, Russia, United States 21 45 Climatic zone II ( Mediterranean, Subtropical) Japan, United States, Southern Europe 25 60 Climatic zone III ( Hot, dry) Iran, Iraq, Sudan 30 35 Climatic Zone IV(Hot, humid) India, Brazil, Ghana, Indonesia, Nicaragua 30 70 10/12/2012 11 TKCP,Warananagar Conti…

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Statement and labeling Q1 A (R2) guidelines Stress Testing Carried out on a single batch and it include the effect of temperatures, humidity where appropriate, oxidation and photolysis on DS. Scope:These guidelines help to identify the likely degradation products, to establish the degradation pathway and intrinsic stability of the molecule. Case study:ornidazole 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. 10/12/2012 12 TKCP,Warananagar

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Statement and labeling Container Closure system Stability study conducted on the drug substance packed in a container closure system that is same or simulate packaging proposed for storage and distribution. Specification These guidelines states the list of test, references to analytical procedure and proposed acceptance criteria. 10/12/2012 13 TKCP,Warananagar

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Statement and labeling Testing frequency For products with a proposed shelf life of at least 12 months: At accelerated storage condition : a minimum of three time points (0, 3 and 6 months), from a 6-month study. At Intermediate storage condition : a minimum of four time points (0, 6, 9 and 12 months), from a 12- month study. 10/12/2012 14 First year------------------3 month Second --------------------6 month Thereafter------------------annually TKCP,Warananagar

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Statement and labeling Storage conditions 10/12/2012 15 Case Storage condition Minimum time period General case 25 °C ± 2°C / 60 % ± 5% RH 12 months Packaged in Semi-permeable containers 25°C ± 2°C / 40% RH 12 months Intended for storage in a Refrigerator 5°C ± 3 °C 12 months Intended for storage in Freezer -20°C ± 5°C 12 months TKCP,Warananagar

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Statement and labeling Stability commitment If submission includes data from stability studies on at least three production batches. If submission includes data from stability studies on fewer than three batches. If submission does not include stability data on production batches. Evaluation The purpose of stability study is to establish re-test period (DS) and shelf life (DP) for future batches based on evaluation of results obtained from Chemical, Physical, Biological, Microbiological tests. 10/12/2012 16 TKCP,Warananagar

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10/12/2012 17 Statement and labeling Statement and labeling A storage statement established for labeling in relevant national/regional requirements. should be established based on the stability evaluation of the drug substance. Terms such as “ambient conditions” or “room temperature” should be avoided. Retest date for DS and Expiry date for DP should be displayed on the container label if appropriate. TKCP,Warananagar

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10/12/2012 18 To demonstrate that light exposure does not result in unacceptable change Testing is carried out on a single batch Testing carried out on: Drug substance Exposed drug product outside of the immediate pack Drug product in the immediate pack Drug product in the marketing pack Light sources: artificial daylight f luorescent lamp combining visible and ultraviolet (UV) outputs, xenon or metal halide lamp. Photostability Testing ICH Q1B GUIDELINE TKCP,Warananagar

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10/12/2012 19 e.g. : Photodegradation of indigo Photodegradable drug: Alprazolam , Chlorothiazide , Chloroquine , Ibuprofen, Isoniazid , Sumatriptan , Valsartan Case study: Amlodipine Conti… TKCP,Warananagar

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10/12/2012 20 ICH Q1C GUIDELINE Stability Testing for New Dosage Forms New dosage forms: Same active substance Different administration route New specific functionality/delivery systems Different dosage forms of same administration route. Reduced stability database ICH Q1C GUIDELINE TKCP,Warananagar

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10/12/2012 21 Bracketing: Only samples on the extremes of certain design factors are tested at all time points as in a full design. Design Factors : >Strength > Container Closure Sizes and/or Fills Strength 50 mg 75 mg 100 mg Batch 1 2 3 1 2 3 1 2 3 Container size 15 ml T T T T T T 100 ml 500 ml T T T T T T TKCP,Warananagar Bracketing and matrixing Design for stability testing of new drug substance and products ICH Q1D GUIDELINE

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10/12/2012 22 Matrixing : Matrixing is t he statistical design of a stability schedule. Each storage condition should be treated separately under its own matrixing design. A t a given time point (other than the initial or final ones) not every batch on stability needs to be tested. Full testing must be performed at the maximum storage period at the time of submission . Time point 0 3 6 9 12 18 24 36 Strength S1 B1 T T T T T T B2 T T T T T T B3 T T T T T S2 B1 T T T T T B2 T T T T T T B3 T T T T T TKCP,Warananagar

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10/12/2012 23 Protocol Parameter Description Storage conditions (including tolerances) and testing frequency 25°C/60% RH 0,3,6,9,12 months 30 o C/75% RH 0,3,6,9,12 months 40°C/75% RH 0,3,6 months Batch number and size L40438 ( Jan. 2005 ), 80.50 k g L50041 ( Feb.2005 ), 69.00 k g L50054 (March 2005 ), 73.00 kg Container closure system(s) Amber colored glass container with metallic screw cap. Tests and acceptance criteria Assay by(98.0-102.0%), ImpA (NMT 0.15%), ImpB (NMT0.3%), and so on Other (s) Stress testing, including photostability testing according to ICH Q1B STABILITY PROTOCOL FOR ORAL SUSPENSION: TKCP,Warananagar

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10/12/2012 24 Provide information regarding common stability data that should be submitted in registration process. Stability studies should be planned on the basis of pharmaceutical R+D and regulatory requirements. Forced degradation studies reveal the intrinsic chemical properties of the API, while formal stability studies establish the retest date. The shelf life (expiry date) of DP is derived from formal stability studies. CONCLUSION TKCP,Warananagar

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10/12/2012 25 REFERENCES ICH official web site. www.ich .org www.ema.europa.eu World Health Organization WHO Technical Report Series, No. 953, 2009 Drug Stability: Principles and Practices , 3rd Edition , edited by Jens T. Carstensen and C. T. Rhodes Statistical Evaluation of Stability Data: Criteria for Change-over-time and Data Variability ( PDA Journal of Pharmaceutical Science and Technology, Vol. 57. No.5, Sept./Oct. 2003, pp. 369-377 ) TKCP,Warananagar

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10/12/2012 26 TKCP,Warananagar

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10/12/2012 27 Topic is open for discussion..! TKCP,Warananagar

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10/12/2012 TKCP,Warananagar 28 Contact on: Mr. Amol M. Sabale Email Id: amolpharma11gmail.com

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