Expiration dating and stability testing for human drug products

This article examines the decisions to be made regarding the design of a stability strategy during development and some alternative approaches, compared to those traditionally followed, are proposed as being more scientifically rigorous.Following these approaches would lead to better product understanding and robustness as well as to a reduction in the number of scientifically redundant stability studies.For all other applications, including More information Guidance for Industry Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation U. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) More information Regulatory Considerations for Peptide Drug Products Larisa C.

Traditional stability studies overview The development of the ICH stability guidelines led to a significant degree of harmonization of expectations and, more recently, the World Health Organization (WHO) stability guideline has extended the reach of these efforts [2,3].

However, although the guidelines state that alternative approaches can be used when scientifically justified, pharmaceutical companies may be reluctant to propose any significantly different approaches when subsequent long delays may be incurred to a development program if a regulatory body refuses to accept the alternative approach followed.

DOE experiments to obtain a design space of a unit operation.

Drying and granulation process monitored by Near IR and chemical imaging. Sci., 2006, 95, Group 1A: Products with No Failures ( 10 lots tested) Drug Product Dosage Form Tested Mean Amoxicllin Sodium Tablets Ciprofloxacin Tablets Diphenhydramine HCl Syringe-Needle a Doxycycline Hyclate Capsules b Doxycycline Hyclate Powder b Halothane Liquid Mannitol Injection-Solution Morphine Sulfate Syringe-Needle c Naloxone HCl Injection-Solution Oxacillin Sodium Powder Potassium Iodide Tablets d Sodium Bicarbonate Injection-Solution Sodium Chloride Irrigation e Sodium Nitrite Injection-Solution Sodium Thiosulfate Injection-Solution Cefoperazone Sodium Powder 4 46 Assay Cephapirin Sodium Powder Potency Cimetidine HCl Injection-Solution c 7 42 Assay Dextrose (5%) Injection-Solution Assay; Appearance i Flurazepam HCl Capsules 3 35 Appearance Morphine Sulfate Autoinjector d 3 32 Degradant Ophthalmic Irrigating Solution 6 52 Low ph Pancuronium Bromide Injection-Solution Assay (1) Ringer s, Lactated and Dextrose Injection-Solution Assay k ; Assay, Appearance Sodium Chloride Injection-Solution e Assay; ph Sodium Polystyrene Sulfonate Powder 3 55 Water Content Sulfadiazine Silver Cream High ph & Assay Tetracycline HCl Capsules Dissolution ; Degradant Thiopental Sodium Powder Low ph ; Appearance 18 SLEP Participants Current Do D participants US Army US Air Force US Navy US Marines CDC/Strategic National Stockpile (SNS) since 2004 Dept.

Some product could be dangerous if used after expiration SLEP program is restricted to certain federal agencies at this time Repackaged metoprolol tartrate tablets Product integrity compromised at accelerated conditions. Percentage, Ratio Strength, and Other Expressions of Concentration 1 PERCENTAGE The term percent and its corresponding sign (%) mean "by the hundred" or "in a hundred," may also be expressed as a ratio, More information SCIENTIFIC APPROACHES TO ASSESS QUALITY AND PERFORMANCE OF TOPICAL PRODUCTS Avraham Yacobi, Ph. Pharmaceutical Quality Assurance Participants Guide Drug and Therapeutics Committee Training Course Participants Guide This document was made More information INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY More information Auvi-Q (epinephrine injection) 0.15mg and 0.3mg (Sanofi) On Oct.

Repackaged Phenytoin Sodium Suspension Product uniformity, potency, and dissolution compromised at initial time point itself Repackaged Ranitidine HCl Syrup, Furosemide Tablets, and Gabapentin Capsules no stability issues in the conditions of experiment 27 The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit CPMP/ICH/380/95 ICH Topic Q 1 A Stability Testing Guidelines: Stability Testing of New Drug Substances and Products More information Understanding and predicting product shelf-life Dr. 28, 2015, Sanofi recalled all lots (numbered between 22995230; expiring between March 2016 and December 2016) of both strengths More information Calculations for Pharmacy Technicians CATEGORIES Conversions --- weight and volume --- Fahrenheit and Celsius Concentration --- mg/ml, percent and ratio Dosage Calculations --- retail and hospital --- More information 11/22/2016; Page 1 Note: Calcium Citrate Tetrahydrate 711 mg is equivalent to Calcium 150 mg; Magnesium Citrate (Tribasic) 619 mg is equivalent to Magnesium 100 mg; Zinc Sulfate (Monohydrate) 34.25 mg More information Combination Products Presented by: Karen S. Ruff OBJECTIVE To determine the suitability of manufacture of a novel solid More information Guidance for Industry Changes to an Approved NDA or ANDA U. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) April 2004 CMC Revision More information Comparative Study of In-process and Finished Products Quality Control Tests of IP, BP & USP for Tablets Vinay.12 SLEP: Program Operation Drug Lot Stored in Military/SNS/VA Stockpile Samples SLEP Military/ SNS/VA Contact Samples New Expiration Date FDA Field Lab Testing Samples Test Results FDA SLEP Coordinator Tests/Test methods/location of standards/procedures/research (when needed) Data Evaluation, Analysis, and Estimations of New Expiration Date FDA CDER Chemist Analysis Lyon et. of Veterans Affairs (VA) since 2005 Only Federal agencies that sign an MOA with DOD may participate in SLEP 19 Research Lessons Learned Actual shelf life may be much longer than indicated by expiration date on the product original label. Continued testing and systematic evaluation is required to ensure product quality.Analyses of the successes and failures can help in applying this information to new product development.Mathias Kramer Purpose of Stability Testing What affects Stability? Ginsbury For: IFF March 2014 Types of products Biological and medical device (freeze dried syringe dual volume) Medical device and plasma devised product (syringe) More information The Use of Acrylic Resins for Improved Aqueous Enteric Coating Charles A. S, Sudeendra Bhat R., Balamuralidhara V * and Pramod Kumar T. Pharmaceutical Quality Assurance More information International GMP Requirements for Quality Control Laboratories and Recomendations for Implementation Ludwig Huber, Ph. [email protected] GMP requirements for Quality Control laboratories More information Blood, Plasma, and Cellular Blood Components INTRODUCTION This chapter of the Guideline provides recommendations to Sponsors of Requests for Revision for new monographs for blood, plasma, and cellular More information (Page 1 of 5) Technician Tutorial: Drug Expiration Dates Expiration dates of drugs can be a confusing subject in the pharmacy.Evaluation of Stability Data Reasonable Stability Testing Conclusion Purpose of Stability More information SADC GUIDELINE FOR STABILITY TESTING 2004 This guideline is intended to provide requirements to applicants wishing to submit applications for the registration of medicines. Res., 2011, 3(2):892-898 World Health Organization s Guidelines for More information VALIDATION OF ANALYTICAL METHODS 1 GERT BEUVING INTERNATIONAL PHARMACEUTICAL OPERATIONS TASKS: - Internal auditing - Auditing of suppliers and contract manufacturers - Preparing for and guiding of external More information INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS More information Guidance for Industry Q1A(R2) Stability Testing of New Drug Substances and Products U. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) More information Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products Questions and Answers U. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation More information European Medicines Agency Inspections London, 17 December 2003 CPMP/QWP/122/02, rev 1 corr COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) GUIDELINE ON STABILITY TESTING: STABILITY TESTING OF EXISTING More information RESTRICTED STABILITY TESTING OF ACTIVE SUBSTANCES AND PHARMACEUTICAL PRODUCTS Discussions are currently ongoing with the WHO Eastern Mediterranean Region towards a synergistic approach in developing a More information World Health Organization WHO Technical Report Series, No. Signorino,* Stephen Levine, Aaron Barkley, and Lou Forcellini Recent technology improvements have made acrylics the preferred system More information AMBERLITE IRP69 Pharmaceutical Grade Cation Exchange Resin (Sodium Polystyrene Sulfonate USP) Description AMBERLITE IRP69 [1] resin is an insoluble, strongly acidic, sodium form cation exchange resin supplied More information Manufacturing Scale Up of a Novel Drug Delivery System Joe Cobb, R. There are a number of reasons for this, including misunderstandings about More information Veterinary Compounding Veterinarians occasionally use compounded preparations to meet a specific patient s medical need.It represents SADC current thinking More information Available on line of Chemical and Pharmaceutical Research ISSN No: 0975-7384 CODEN(USA): JCPRC5 J. 953, 2009 Annex 2 Stability testing of active pharmaceutical ingredients and finished pharmaceutical products 1. Division of Generic Animal Drugs AAVPT Veterinary Drug Regulatory Life Cycle Course Bioequivalence Requirement Any person submitting More information Guidance for Industry Q2B Validation of Analytical Procedures: Methodology November 1996 ICH Guidance for Industry Q2B Validation of Analytical Procedures: Methodology Additional copies are available from: More information 1.1 ICH Q1A(R2) Guideline Stability Testing of New Drug Substances and Products Comments for its application ICH Q1AR2 C 16 ICH Q1(R2) Stability testing Guidelines: Stability Testing of New Drug Substances More information INTERNATIONAL RESEARCH JOURNAL OF PHARMACY ISSN 2230 8407 Available online Article COMPARATIVE STUDY OF IN-PROCESS AND FINISHED PRODUCTS QUALITY CONTROL TESTS OF INDIAN PHARMACOPOEIA, More information Step-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry BY GHULAM A. of Physico chemistry vaccine and serum research institute [email protected] Introduction Test procedures for assessment of the More information PRODUCT DEVELOPMENT GUIDE PRE-FORMULATION - TABLETS Introduction Guidelines for the development of a ANDA product for the US market, Note: some tests or procedures may be unnecessary. FIP/SIG Chair, Regulatory Sciences Pharmaceutical Consultant (Formerly with US FDA) 2 nd MENA Conference on Bioequivalence, Biowaivers, Bioanalysis, More information World Health Organization WHO Technical Report Series, No. The purpose of this brochure, created jointly by the Animal Health Institute (AHI), More information European Medicines Agency August 2003 CPMP/ICH/420/02 ICH Topic Q 1 E Evaluation of Stability Data Step 5 NOTE FOR GUIDANCE ON EVALUATION OF STABILITY DATA (CPMP/ICH/420/02) TRANSMISSION TO CPMP February More information Paracetamol 1000 mg Effervescent Tablets PL 31388/0005 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 12 Summary of Product Characteristics Page More information UNIT 5 BIOAVAILABILITY AND BIOEQIVALENCE S. PHARM., (Ph.d) Department of Pharmaceutics SRM College of Pharmacy SRM University BIOAVAILABILITY INTRODUCTION The bioavailability or systemic More information Direction NEURHO /DP3 Neurologie-Psychiatrie-Antalgie-Rhumatologie- Pneumologie-ORL-Ophtalmologie-Stups et psychotropes PUBLIC ASSESSMENT REPORT Scientific Discussion ASPROFLASH 500mg, Coated Tablets Acetylsalicylic More information Overview of Pre-Approval Inspections Presented by: Kelli F. Premises and facilities More information AMBERLITE IRP64 Pharmaceutical Grade Cation Exchange Resin (Polacrilex Resin) Description AMBERLITE IRP64 [1] resin is an insoluble, weakly acidic, hydrogen form, cation exchange resin supplied as a dry, More information Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System Guidance for Industry DRAFT GUIDANCE This guidance More information Implementation of ICH Q8, Q9, Q10 Workshop A Design Space (DS) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Disclaimer The information More information Quantitative work in HPLC Dr. Shulamit Levin, Medtechnica 1 Quantitative work in HPLC Dr.Introduction 1.1 Objectives of More information ICH-GCG ASEAN Workshop B Control Strategy Jean-Louis ROBERT, Ph. National Health Laboratory, Luxembourg Chair-person ICH IWG Q8, Q9, Q10 Kuala Lumpur, 26-28 July 2010 International Conference on Harmonisation More information European Medicines Agency August 2003 CPMP/ICH/2736/99 ICH Topic Q 1 A (R2) Stability Testing of new Drug Substances and Products Step 5 NOTE FOR GUIDANCE ON STABILITY TESTING: STABILITY TESTING OF NEW More information Page 1 of 10 BRIEFING 7 Labeling. SHABIR Introduction Methods Validation: Establishing documented evidence that provides a high More information Development & The US FDA Approval of Generic Drugs May 18, 2011 Beijing, China SHAO Jun, Ph. Agenda About Generic Drugs Business Strategy for Generic Drugs Generic Drug Product Development Generic Drug More information Analytical Method Validation for Assay, Related substances & Dissolution. The order of performing More information Bioequivalence and Drug Product Quality Vinod P. 953, 2009 Annex 2 Stability testing of active pharmaceutical ingredients and finished pharmaceutical products 1. Dobilas NWJ-DO Pre-Approval Manager Pre-Approval Drug Inspections What are Pre-Approval Inspections? SCOPE OF THE ANNEX More information INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE PHARMACEUTICAL DEVELOPMENT Q8(R2) Current Step More information World Health Organization WHO Technical Report Series, No. Shulamit Levin Medtechnica Data Handling Analytical Chemistry More information ANDA CHECKLIST FOR CTD or ectd FORMAT FOR COMPLETENESS and ACCEPTABILITY of an APPLICATION FOR FILING For More Information on Submission of an ANDA in Electronic Common Technical Document (ectd) Format More information MEASUREMENTS AND CONVERSIONS RATIO AND PROPORTIONS PERCENTAGES DILUTIONS Hertha Darezzo, CPh T Our Lady of Fatima Hospital Charter CARE Health Partners I have no relevant financial relationships to disclose.22 Repackaged Product Background The draft guidance, CPG 7132.b11, specifies conditions where it may be possible to assign up to 12 months expiration dating to non-sterile solid and liquid oral dosage form drug products repackaged into unit dose containers for Class A, without conducting new stability studies.According to USP, a unit dose container is designated Class A if not more than 1 of 10 containers exceed 0.5 mg/day in moisture permeation rate, and none exceeds 1 mg/day. More information SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT Guideline Title Specifications and Control Tests on the Finished Product Legislative basis Directive 75/318/EEC as amended Date of first adoption More information Biopharmaceutics Classification System based on Solubility/Permeability Biowaivers for BCS I Drugs Discussion of BCS III Drugs Models establishing in vivo-in vitro Correlations (IVIVC Levels A-C) 1 Biopharmaceutics More information Excipients Facing Increased Scrutiny How to Use Secondary Reference Standards to Help Maintain Regulatory Compliance by Tom Savage, NSF International Since 2008, when patient deaths were first linked to More information GDUFA Regulatory Science Update Robert Lionberger, Ph. Director Office of Research and Standards Office of Generic Drugs Center for Drug Evaluation and Research, FDA GPh A Annual Meeting Feb 9, 2015 Goals More information Guidance for Industry Immediate Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation More information English translation of Attachment 2 of Division-Notification 0229 No.Prescription drug products stability and expiration dates* UTMB/NASA-JSC Aerospace Medicine Grand Rounds Houston, TX October 27, 2009 Mansoor A. It is expected that a well designed formulation and packaging protects the product from degradation A shelf-life generally means a product will retain approved specs in the final packaged container, in stated storage conditions, when tested by validated methods An expiration date must be placed on container label (21 CFR ). Applicant conducts systematic stability testing (21 CFR ) according to a prescribed protocol Select samples from representative batches Store samples at defined storage conditions* Accelerated (40ºC/75% relative humidity or RH) Long-term (25ºC/60% RH) Intermediate (30ºC/65% RH), if needed *(Other stress conditions, e.g., light, acid, base, oxidant, for one-time testing) Pull samples at predetermined intervals 8 How is Shelf Life Established? Factors such as temperature, humidity, light, ph, ionic strength, buffer strength could enhance the degradation.


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