LEGAL REQUIREMENTS FOR STABILITY
|
|
- Margaret Shaw
- 6 years ago
- Views:
Transcription
1 BY DR. A.V.PRABHU
2 LEGAL REQUIREMENTS FOR STABILITY 21 CFR STABILITY TESTING GMP To assess stability characteristics to determine storage conditions and expiration dates. Written stability program includes sample size, test interval, storage conditions, specific methods and container closure. 21 CFR (d): Content of Format Drug substance and Drug Product stability Stability Specifications and Analytical Methods Stability Data and proposed expiration
3 WHY STABILITY? Provide evidence on how the quality of a drug / drug product varies with time under the influence of a variety of environmental factors like 1.Temperature 2.Humidity 3.Light Establishes Retest period for the drug substance Shelf life for the drug product Recommend a storage conditions Because physical, chemical or microbiological changes might impact the efficiency or security of the final product.
4 STABILITY Stability studies are performed on Drug Substances / API / BPC Drug Product or Dosage Forms And Represents Controlled and documented determinations of acceptable changes to Drug Substances / Drug Products
5 STABILITY What are Physical Changes Appearance Melting Point Clarity and colour of solution Crystal modification (Polymorphism) What are Chemical Changes? Increase in Degradation Product Decrease of Assay What are microbial changes? Growth of Microorganism
6 SIGNIFICANT CHANGES DURING STABILITY A 5 % change in Assay from its initial value Any degradation product exceeding its acceptance criteria Failure to meet the acceptance criteria for Appearance, Physical attributes and functionality test (e.g. Colour, phase separation, hardness) As appropriate for the dosage form Dissolution specification for release of stability must be same (may affect Bio Equivalence)
7 CAUTION The Assay value is still within limit but the change during stability is more than 5.0 % Release Assay Limit 95.0 to 103 % Stability Assay Limit 92.5 to % Release Assay % 24 month Assay 93.0 % Loss in Potency 8.0 % THIS IS A SIGNIFICANT CHANGE
8 WHAT IS A RETEST PERIOD? The period of time during which API is expected to remain within its specifications and therefore can be used in the manufacture of a given Drug Product. Provided the API is stored under defined storage condition After this period, a batch of API destined for use in the Drug product, should be retested for compliance with the specifications and used immediately. A batch of API can be retested multiple times and a different portion of the batch used after each retest as long as it continues to comply with specifications.
9 EXPIRY / EXPIRATION DATE The date placed on the container label of a DS /DP designating the time prior to which a batch of DS/DP is expected to remain within the approved shelf life specification under defined storage conditions No retesting is permitted beyond expiration date and the DS / DP must not be used
10 WHAT ARE STABILITY INDICATING METHOD They are validated, quantitative test methods that can detect changes with time in the chemical, physical or microbiological properties of Drug Substance or Drug Product They are specific, so that the quantity of Active products and other components of interest can be accurately measured without interference in the material tested. The ability to differentiate the Active ingredients from closely related process and degradative impurities is usually the single most important requirement for stability indicating methodology.
11 WHY ARE STABILITYINDICATING METHOD NECESSARY The GMP requires a formal written stability testing program whose results are used to establish storage conditions, expiration dates of Drug Products / Substances and further mandates the use of reliable, meaningful and specific test methods
12 WHEN ARE STABILITYINDICATING ANALYTICAL METHOD NECESSARY The use of such methods is appropriate when there is an intention to document Drug product stability. These data are used to establish, conform or extend retest intervals or expiration dating periods for Drug Substance / Drug Product
13 WHAT IS THE ROLE OF QA IN DEVELOPMENT There is a need for an energized Quality Assurance function that promotes changes and uses teams to handle new regulatory challenges and exploit technological opportunities. By turning Quality Assurance into a self challenging, manufacturing science promoting organization, a true value will be added to its traditional mission of guaranteeing that quality products are put in market place and also realigning quality objectives with customer expectations.
14 WHERE DOES THE QA ROLE BEGIN? Bring Quality and manufacturing into the development process as early possible. It helps ensure that the process are carried out in a controlled documented way, thus facilitating Technology Transfer and expediting launching of new products
15 WHAT IS THE QA ROLE IN TECHNOLOGY TRANSFER Raw Material specification and method of analysis In-process specifications Standard Operating Procedures Development Batch Records Manufacturing Batch Records Deviation Reports Investigation Reports and CAPA Stability Protocols Validation Reports Stability Data Reports Assay Method Development and Transfer Reports and Associated Training Documents Manufacturing Summary Reports for Submissions Development History Reports Final Product Specifications- Rationale Testing Monographs Training Records
16 A TYPICAL STABILITY PROTOCOL / REPORT Information on batches tested (Commercial formula) Unit Composition Container Closure System Analytical methods Stability Plan or Schedules Tabulated Test Results Analysis / Discussions of Data ( Statistical negative trends) Shelf Life Proposed or Retest Literature and/or Supporting Data
17 WHERE DOES QA ROLE IN STABILITY BEGIN? Development Pharmaceutics Analytical Method Validation LOD & LOQ Right Primary Standards Including Impurities Equipment Validation especially stability ovens OOS/OOT Investigations and reporting Training Stability Packaging
18 WHAT ARE MOST FREQUENT 483 s OBSERVATIONS ON STABILITY Failure to Establish Stability Procedures and Expiration Dates Expiration Dating not Supported By Data Failure to Follow Established Stability Protocols Failure to Use or Validate Stability Indicating Methods Stability Protocols not signed by Quality Unit Stability Samples were not Representating of current Formulations No Qualification Data for Stability Chambers No Investigation and Documentation of OOS No Shipping Records for Stability Samples, Lots Not Traceable.
19 RISK/FAILURES Oven Failures-- Alarm, standyby compressors Heat Distribution No Proper Log Book Entries No Pack Simulation Sample analysis beyond point Reference / Primary Standards, Solution Stability
20
Contents. Contents (13) 1 Production (23)
1 Production (23) 1.A Sanitation (27) 1.A.1 Organisational prerequisites (27) 1.A.2 Sources of contamination (28) 1.A.3 Responsibilities and implementation (29) 1.B Personnel hygiene (31) 1.B.1 Clothing
More informationQuality Issues for Clinical Trial Materials: The Chemistry, Manufacturing and Controls (CMC) Review
Quality Issues for Clinical Trial Materials: The Chemistry, Manufacturing and Controls (CMC) Review Presented by Erika E. Englund, Ph.D. Slides courtesy of Dorota Matecka, Ph.D. Office of Pharmaceutical
More informationWHO GUIDELINE Stability testing of active pharmaceutical ingredients and finished pharmaceutical products
WHO GUIDELINE Stability testing of active pharmaceutical ingredients and finished pharmaceutical products 1. Introduction 1.1 Objectives of these guidelines 1.2 Scope of these guidelines 1.3 General principles
More informationAPI Stability Protocols and. Chris Byrne Tasmanian Alkaloids
API Stability Protocols and Evaluations Chris Byrne Tasmanian Alkaloids API Stability Overview APIs = 100% pure Limited (if any) degradation No interactions with other agents in drug products Less likelihood
More informationManual 055 Commercial Stability Testing For Formulated Products. This procedure applies to all drug products. The procedure covers:
1 Purpose Manual 055 Commercial Stability Testing For Formulated Products The intent of this procedure is to provide to manufacturing and primary packaging sites the principles of a stability program.
More informationControl Strategy. Implementation of ICH Q8, Q9, Q10
Implementation of ICH Q8, Q9, Q10 Control Strategy International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Introduction Structure of this session
More informationSTABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
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 informationSubpart B Organization and Personnel, 21 CFR Responsibilities of the quality control unit.
FDA inspections continue to focus on CGMP violations related to basic GMP controls. A survey of Warning Letters issued in 2013 on CMC (Chemistry / Manufacturing / Controls) violations reveals an emphasis
More informationEffective Management and Operations of GXP Laboratories
Effective Management and Operations of GXP Laboratories Course Objective: Upon completion of this course, attendees involved in establishing and assuring that Good Laboratory / Good Manufacturing Practice
More informationDrug Quality Assurance: Systems at ChemCon Author: Dr. Peter Gockel
Drug Quality Assurance: Systems at ChemCon Author: Dr. Peter Gockel On February 13th, 2006, the FOOD AND DRUG ADMINISTRATION (FDA) implemented a revision to the Compliance Program Guidance Manual for active
More informationEUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL. EudraLex The Rules Governing Medicinal Products in the European Union
EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, 25 October 2005 EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU
More informationChemical Aspects of Stability Evaluation
Chemical Aspects of Stability Evaluation 8 steps to generating stability data which speaks for itself Alan Doughty Chief Chemist Pty Ltd Aim of a stability trial Obtain data which allows a definitive conclusion
More informationPMDA Views on Applying Continuous Manufacturing to Pharmaceutical Products for Industry (provisional draft)
PMDA Views on Applying Continuous Manufacturing to Pharmaceutical Products for Industry (provisional draft) March 30, 2018 Pharmaceuticals and Medical Devices Agency Innovative Manufacturing Technology
More informationGood practices in quality control in pharmaceutical industry - Overview of regulatory guidelines
Review Article Good practices in quality control in pharmaceutical industry - Overview of regulatory guidelines Chagi Venkatesh*, S. B. Puranik ABSTRACT Good practices in quality control (QC) department
More informationFDA S GUIDANCE FOR INDUSTRY ANDAS: STABILITY TESTING OF DRUG SUBSTANCES AND PRODUCTS
FDA S GUIDANCE FOR INDUSTRY ANDAS: STABILITY TESTING OF DRUG SUBSTANCES AND PRODUCTS 02-December-2014 San Diego, CA Kim Huynh-Ba Executive Director PHARMALYTIK Kim.huynhba@pharmalytik.com Overview Stability
More informationEudraLex. Part I1 Chapter 6: Quality Control
EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines tofor Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Part I1 Chapter 6: Quality
More informationEUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. EudraLex. The Rules Governing Medicinal Products in the European Union
Ref. Ares(2014)968036-28/03/2014 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products quality, safety and efficacy Brussels, 28 March 2014 EudraLex
More informationFOOD AND DRUGS AUTHORITY
G H A N A FOOD AND DRUGS AUTHORITY GUIDELINES FOR STABILITY TESTING OF ACTIVE PHARMACEUTICAL INGREDIENTS AND FINISHED PHARMACEUTICAL PRODUCTS Document No: FDA/DRI/DER/GL-STP/2013/07 Date of First Adoption:
More informationWhy Do I Test, What Do I Test & When Do I Test It? Ross Caputo, PhD Chief Technical Officer Eagle Analytical Services
Why Do I Test, What Do I Test & When Do I Test It? Ross Caputo, PhD Chief Technical Officer Eagle Analytical Services Disclosures I, Ross Caputo, declare no conflicts of interest, real or apparent, and
More informationDocumenta tion and Records
Documenta tion and Records Page 1 of 30 Training Outcome of the Module: After completing this module, you will be able to: Recognize the importance of procedures Recognize the importance of record keeping
More informationGUIDELINES ON THE STABILITY DATA REQUIRED FOR REGISTRATION OF STOCK REMEDIES IN SOUTH AFRICA
GUIDELINES ON THE STABILITY DATA REQUIRED FOR REGISTRATION OF STOCK REMEDIES IN SOUTH AFRICA Issued by the Registrar: Act No. 36 of 1947, Private Bag X343, Pretoria 0001 Republic of South Africa Tel. (**27
More informationGMP The Other Side of Chemistry, Manufacturing & Controls (CMC)
Overview of USFDA Drug Regulatory Requirements Pharmaceutical Quality and Facility Inspections (GMP) Session II 19 February 2014 Casablanca, Morocco GMP The Other Side of Chemistry, Manufacturing & Controls
More informationEstablished Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Guidance for Industry
Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments
More informationThe GCC Guidelines for Stability Testing of Drug Substances and Pharmaceutical Products EDITION TWO 1428 H 2007 G
The GCC Guidelines for Stability Testing of Drug Substances and Pharmaceutical Products EDITION TWO 1428 H 2007 G (1) INTRODUCTION The following guideline defines the stability data package for a drug
More informationCOMMERCIAL PRODUCT STABILITY
COMMERCIAL PRODUCT STABILITY Being Responsible for your Tweener, Senior Citizen and Hospice Stage Products Melissa Lambert Global Head Stability in Quality & Compliance Management, R&D Director Quality
More informationCharity Ogunsanya CEO, Pharmabiodevice Consulting LLC Copyright 2014 By Pharmabiodevice Consulting LLC
Charity Ogunsanya CEO, Pharmabiodevice Consulting LLC www.pharmabiodeviceconsultant.com 10:00 a.m. 10:15 a.m. Introduction to the Virtual Conference Introduction to the Stability Testing Program Why Perform
More informationEquipment cleaning and use record
DOCUMENTATION Documentation is an essential part of the quality assurance system and, as such, should be related to all aspects of GMP. Its aim is to define the specifications for all materials and the
More informationCOMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP)
The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use London, 17 December 2003 CPMP/QWP/122/02, rev 1 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) GUIDELINE
More informationFuture of Question-based Review and Regulatory Submissions
Future of Question-based Review and Regulatory Submissions Robert Iser Associate Director for Policy Development (Acting) Office of Pharmaceutical Science / CDER / FDA FDA/PQRI Conference on Evolving Product
More informationQuestion-based Review (QbR)
Question-based Review (QbR) Rebecca L. Owen, Ph.D. Team Leader, Feed/Topical Team Division of Manufacturing Technologies ONADE/CVM/FDA Outline Background on CMC Filing Requirements What is QbR? QbR at
More informationDEPARTMENT OF AGRICULTURE, FORESTRY & FISHERIES STABILITY
DEPARTMENT OF AGRICULTURE, FORESTRY & FISHERIES STABILITY This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Stock Remedies. It represents
More informationá1225ñ VALIDATION OF COMPENDIAL PROCEDURES
1640 á1224ñ Transfer of Analytical Procedures / General Information USP 39 THE ANALYTICAL PROCEDURE The procedure should be written with sufficient detail and explicit instructions, so that a trained analyst
More informationWHO DRAFT PHARMACEUTICAL DEVELOPMENT FOR MULTISOURCE (GENERIC) PHARMACEUTICAL PRODUCTS
23 April 2008 Quality Assurance Programme Quality Assurance and Safety: Medicines (QSM) Department of Medicines Policy and Standards (PSM) World Health Organization CH-1211 Geneva 27 Switzerland WHO DRAFT
More informationAn Overview of IQ s Position Paper: Early Development GMPs for Small-Molecule Specifications
An Overview of IQ s Position Paper: Early Development GMPs for Small-Molecule Specifications On behalf of Specifications Team Kirby Wong-Moon, Ph.D. Amgen Inc. Best Practices and Application of GMPs for
More informationEssentials in Stability Analysis and Expiry Determination
Published in BioPharma International. Essentials in Stability Analysis and Expiry Determination Thomas A. Little Ph.D. 6/12/2013 President Thomas A. Little Consulting 12401 N Wildflower Lane Highland,
More informationExtending Beyond Use Dating for Compounded Preparations Webinar Q&A
Stability Studies 1. If potency over time studies are not acceptable to extend BUD, then why is it offered? Potency point-in-time studies only indicate the potency of a compounded preparation at that specific
More informationInternational Journal of Pharma and Bio Sciences DEVELOPMENT OF ACCELERATED STABILITY PROTOCOL FOR SILDENAFIL TABLETS A EUROPEAN PERSPECTIVE REVIEW
International Journal of Pharma and Bio Sciences DEVELOPMENT OF ACCELERATED STABILITY PROTOCOL FOR SILDENAFIL TABLETS A EUROPEAN PERSPECTIVE REVIEW SUKHDEV SINGH *1 AND JASBIR SINGH 2 1 Rayat Institute
More informationExtending Beyond Use Dating for Compounded Preparations Webinar Q&A
Stability Studies 1. If potency over time studies are not acceptable to extend BUD, then why is it offered? Potency point-in-time studies only indicate the potency of a compounded preparation at that specific
More informationValidation/Verification of Test Methods An FDA Perspective. Laure H. Kairawicz, Ph.D. Senior Scientist Expert Witness
Validation/Verification of Test Methods An FDA Perspective Laure H. Kairawicz, Ph.D. Senior Scientist Expert Witness FD & C Act Overview Definition of drugs What cgmps are Finished Pharmaceuticals cgmp
More informationDECISION TREE #1: ESTABLISHING ACCEPTANCE CRITERION FOR A SPECIFIED IMPURITY IN A NEW DRUG SUBSTANCE
DECISION TREE #1: ESTABLISHING ACCEPTANCE CRITERION FOR A SPECIFIED IMPURITY IN A NEW DRUG SUBSTANCE Determine impurity level in relevant batches 1 Determine mean + upper confidence limit for the impurity
More informationDraft regional guidelines on stability testing of active substances and pharmaceutical products
Regional Committee for the EM/RC53/12 Eastern Mediterranean August 2006 Fifty-third Session Original: Arabic Agenda item 17 Draft regional guidelines on stability testing of active substances and pharmaceutical
More informationCMC Considerations for 505(b)(2) Applications. Monica Cooper, Ph.D. FDA/CDER/OPS/ONDQA AAPS Annual Meeting Washington, D.C.
CMC Considerations for 505(b)(2) Applications Monica Cooper, Ph.D. FDA/CDER/OPS/ONDQA AAPS Annual Meeting Washington, D.C. October 2011 1 Introduction Outline Brief overview of FDA drug approval pathways
More informationInvestigating OOS for Finished Product on the Stability Program. Presented by: Nicole Chang, QA Manager, Apotex Pty Ltd
Investigating OOS for Finished Product on the Stability Program Presented by: Nicole Chang, QA Manager, Apotex Pty Ltd Overview 1. Requirements of the commercial stability program 2. Out of Specification
More informationAnnex 10. Stability testing of active pharmaceutical ingredients and finished pharmaceutical products. Introduction and background
Annex 10 Stability testing of active pharmaceutical ingredients and finished pharmaceutical products Introduction and background The guidance on Stability testing of active pharmaceutical ingredients and
More information21CFR Ventilation, air filtration, air heating and cooling. 21CFR211 Details, Details. 21CFR Equipment Cleaning and Maintenance
21CFR211 Details, Details Kirsten L. Vadheim, Ph.D., RAC 7710 196th Avenue N.E. Redmond WA 98053 Tel: 651.260.6560 Fax: 425.868.4302 klvadheim@hotmail.com 21CFR211.46 Ventilation, air filtration, air heating
More informationDRAFT GUIDANCE DOCUMENT ADDENDUM - Quality (Chemistry and Manufacturing) Guidance: Questions and Answers
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 DRAFT GUIDANCE DOCUMENT ADDENDUM - Quality (Chemistry and Manufacturing) Guidance: Questions and Answers This guidance document is being distributed for comment
More informationQuality Agreement. by and between. Supplier Name. Address: and. Client Name: Address:
NOTE TO USERS This Quality Agreement template was developed by the Bulk Pharmaceutical Task Force (BPTF), an affiliate organization of the Society of Chemical Manufacturers and Affiliates (SOCMA), as a
More informationGUIDELINE FOR THE STABILITY TESTING
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 GUIDELINE FOR THE STABILITY TESTING OF NON-PRESCRIPTION (OTC)
More informationCGMP Requirements for Investigational Products
PREP #6 CGMP Requirements for Investigational Products Ji-Eun Kim, RPh, PhD Research Pharmacist Regulatory Affairs Office of Research Compliance December 6, 2016 1 CME Disclosure Statement Northwell Health
More informationCommonly Seen Drug Product Related Quality Deficiencies
Commonly Seen Drug Product Related Quality Deficiencies 2016 GPhA CMC Workshop Bethesda, MD; May 18, 2016 Geoffrey Wu, PhD, CPH Lieutenant, US Public Health Service Associate Director for Science & Communication
More informationQ8 Pharmaceutical Development
Q8 Pharmaceutical Development For questions regarding this draft document contact (CDER) Ajaz Hussain at 301-594-2847 or (CBER) Christopher Joneckis at 301-435-5681. This draft guidance, when finalized,
More informationCOMPLIANCE BY DESIGN FOR PHARMACEUTICAL QUALITY CONTROL LABORATORIES INSIGHT FROM FDA WARNING LETTERS
COMPLIANCE BY DESIGN FOR PHARMACEUTICAL QUALITY CONTROL LABORATORIES INSIGHT FROM FDA WARNING LETTERS Primer CONTENTS INTRODUCTION...3 QUALITY AND COMPLIANCE IN QUALITY CONTROL LABORATORIES...5 Compliance
More informationPHARMACEUTICAL TESTING
WHITEHOUSE, NJ PHARMACEUTICAL TESTING Pharmaceutical Expertise for GMP & CMC Testing Our Pharmaceutical Expertise With more than 20 years of experience in a variety of industries, our Whitehouse, New Jersey
More informationMEASURE FOR MEASURE: QUALITY METRICS
MEASURE FOR MEASURE: QUALITY METRICS PDA Midwest Chapter Dinner Meeting, Northbrook, IL-9 November 2017 Felicia Ford-Rice, Director, Strategic Compliance 2017 PAREXEL INTERNATIONAL CORP. AGENDA Robust
More informationOverview of Regulatory Requirements for API and Formulations
Overview of Regulatory Requirements for API and Formulations Sangeeta Sardesai 4-Dec-2010 Definition - Regulatory Requirement The restrictions, licenses, and laws applicable to a product or business, imposed
More informationEVALUATION FOR STABILITY DATA
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE EVALUATION FOR STABILITY DATA Q1E Recommended for
More informationManual 058 Out of Specification Results Investigation
1 Purpose The purpose of this Guideline is to provide guidance for the investigation and response to Out of Specification (OOS) laboratory test results. 2 Scope and Applicability This Guideline applies
More informationExcipients Facing Increased Scrutiny How to Use Secondary Reference Standards to Help Maintain Regulatory Compliance
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 informationMODULE 2.3 QUALITY OVERALL SUMMARY PRODUCT DOSSIER (QOS PD)
MODULE 2.3 QUALITY OVERALL SUMMARY PRODUCT DOSSIER () INTRODUCTION The introduction should include proprietary name, non-proprietary name or common name of the drug substance, company name, dosage form(s),
More informationGUIDELINES FOR INTRODUCING A LOCALLY MANUFACTURED NEW PHARMACEUTICAL PRODUCT ON THE UGANDA MARKET
GUIDELINES FOR INTRODUCING A LOCALLY MANUFACTURED NEW PHARMACEUTICAL PRODUCT ON THE UGANDA MARKET National Drug Authority Head Office Rumee Towers Plot 19, Lumumba Avenue P. O. Box 23096 Kampala, Uganda
More informationHow to Avoid Common Deficiencies in INDs and NDAs. Ramesh Raghavachari, Ph.D. Branch Chief, Branch IX ONDQA/OPS/CDER
How to Avoid Common Deficiencies in INDs and NDAs Ramesh Raghavachari, Ph.D. Branch Chief, Branch IX ONDQA/OPS/CDER 1 Structure of FDA Office of Commissioner Chief Scientist FOODS Medical Products & Tobacco
More informationAuditing Your Laboratory for Compliance with the FDA Dietary Supplement GMP s
Tech Tip 0020 With the advent of the cgmp s, the majority of companies are increasing the frequency of their outsourced analytical testing. But the GMPs are just that, Good Manufacturing Practices, and
More informationRegulatory Aspects of Cleaning and Cleaning Validation. Larry Greenstein Quality Operations, Quality Unit, Bio-Technology General, Ltd.
Regulatory Aspects of Cleaning and Cleaning Validation Larry Greenstein Quality Operations, Quality Unit, Bio-Technology General, Ltd. 28 June 2017 Why clean? Pharmaceutical production equipment is cleaned
More informationASMF/DMF Quality Assessment Report (QAR) IGDRP Quality Working Group
ASMF/DMF Quality Assessment Report (QAR) IGDRP Quality Working Group Version Description of Change Author Effective Date v 1.0 Original publication ASMF/DMF WG May 26, 2015 v 1.1 Watermark added ASMF/DMF
More informationEarly Development Best Practices for Stability- Regulatory Perspective
Early Development Best Practices for Stability- Regulatory Perspective IQ Workshop, Feb. 4-5, 2014, Washington, D.C. Ramesh Sood, Ph.D. Division Director (Acting) Office of New Drug Quality Assessment
More informationRegulatory expectations on impurities in drug substances - Pavia, October 2, Luisa Torchio Euticals SpA
Regulatory expectations on impurities in drug substances - Pavia, October 2, 2015 Luisa Torchio Euticals SpA An Impurity is defined as any substance or element present in a drug substance (DS) that is
More informationRECOMMENDATIONS FOR DIETARY INGREDIENT PROCESSORS
RECOMMENDATIONS FOR DIETARY INGREDIENT PROCESSORS Facilities that manufacture 117, pack, or hold dietary supplements are subject to the regulations in 21 CFR Part 111, while those that manufacture, pack,
More informationStrategies for IND Filing Success: Chemistry, Manufacturing and Controls
Strategies for IND Filing Success: Chemistry, Manufacturing and Controls October 21, 2016 Presented by: Sharon Ayd, Ph.D., MBA Chief Scientific Officer and SVP, Pharmaceuticals document contains proprietary
More informationPrequalification Team WHO PUBLIC INSPECTION REPORT Vaccine Manufacturer
Part 1: General information Name of Manufacturer Production Block Physical address Contact address Prequalification Team WHO PUBLIC INSPECTION REPORT Vaccine Manufacturer. Clean Utilities in the Basement.
More informationQUALITY AGREEMENT. The following Agreement has been concluded between
QUALITY AGREEMENT The following Agreement has been concluded between LLC LABORATORIES The contract laboratory and service provider 1625 Trinity Dr., Unit 11 Mississauga, Ontario Canada L5T 1W9 Hereinafter
More informationLifecycle Product Quality Risk Management
Lifecycle Product Quality Risk Management Richard L. Friedman, M.S. Associate Director Office of Manufacturing and Product Quality Office of Compliance IFPAC Annual Meeting (Arlington, VA) January, 21-24,
More informationGUIDANCE FOR INDUSTRY ON FIXED DOSE COMBINATIONS (FDCs)
GUIDANCE FOR INDUSTRY ON FIXED DOSE COMBINATIONS (FDCs) DRAFT GUIDANCE This guidance document is for feedback purposes only Comments and suggestions regarding this draft document should be submitted within
More informationProcess development and basic GMP
Process development and basic GMP Aulton Chapter 45, handouts Specification, stability, inprocess controls and validation Product development Process development Critical Product Qualities issues Critical
More informationDRAFT OECD GLP ADVISORY DOCUMENT NO. 19 ON THE MANAGEMENT, CHARACTERISATION AND USE OF TEST ITEMS PREAMBLE
DRAFT OECD GLP ADVISORY DOCUMENT NO. 19 ON THE MANAGEMENT, CHARACTERISATION AND USE OF TEST ITEMS PREAMBLE 1. This guidance provides clarity for test facilities on the expectations of national Good Laboratory
More informationOvercome the Top Challenges of Handling OOS Results by Knowing FDA Observations
Overcome the Top Challenges of Handling OOS Results by Knowing FDA Observations Jerry Lanese Ph.D. The Lanese Group, Inc. 2015 The Lanese Group, Inc. 1 Who decided you should come to this conference? On
More informationExperience with Health Canada s Approach for Post-Approval Changes. Kiran Krishnan Vice President US Regulatory Affairs September 2014
Experience with Health Canada s Approach for Post-Approval Changes Kiran Krishnan Vice President US Regulatory Affairs September 2014 Important Quotes to consider Dr. Janet Woodcock on desired state: A
More informationProcess Drift: When Do We Detect it? Richard L. Friedman Director, DMPQ CDER/Office of Compliance PQRI Process Drift Workshop December 1, 2010
Process Drift: When Do We Detect it? Richard L. Friedman Director, DMPQ CDER/Office of Compliance PQRI Process Drift Workshop December 1, 2010 Overview Goal of Manufacturing Central Question: Why is process
More informationGuideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials
1 2 3 18 February 2010 EMA/CHMP/BWP/534898/2008 Committee for Medicinal Products for Human Use (CHMP) 4 5 6 7 Guideline on the Requirements for Quality Documentation Concerning Biological Investigational
More informationPROCESS VALIDATION ROCHAPON WACHAROTAYANKUN, PH.D.
Basic GMP Requirement PROCESS VALIDATION ROCHAPON WACHAROTAYANKUN, PH.D. Topic Process validation What and Why? Principle of process validation Manufacturing process validation Aseptic process validation
More informationApproval Review of Generic Drugs. Office of Generic/OTC Drugs, PMDA Kazuyuki SAITO, Ph.D.
Approval Review of Generic Drugs Office of Generic/OTC Drugs, PMDA Kazuyuki SAITO, Ph.D. Outline of Presentation Introduction Approval Review of Generic Drugs Equivalency review Conformity audit Conclusion
More informationANNEX V ASEAN GUIDELINES ON STABILITY STUDY AND SHELF-LIFE OF HEALTH SUPPLEMENTS
Association of South East Asian Nations (ASEAN) ANNEX V ASEAN GUIDELINES ON STABILITY STUDY AND SHELF-LIFE OF HEALTH SUPPLEMENTS Disclaimer: This document is provided for information purpose only and subject
More informationInternational Journal of Generic Drugs
Photostability STABILITY TESTING in New Drug Products evaluating photostability is foremost for new chemical entities only - not in generic drugs, provided the container-closure protection is the same
More informationGMP On Site Series. GMP Essentials
GMP On Site Series GMP Essentials GMP Basics Objectives 1. State the critical definitions of the pharmaceutical industry. 2. Describe the law as it applies to various critical functions. 3. State the history
More informationFurther Stability Considerations
Further Stability Considerations Radhika Rajagopalan, Ph.D., Team Leader Chemistry Division 2 Office of Generic Drugs, FDA FDA-GPhA Workshop June 4, 2013 1 Agenda Common considerations Q1D Bracketing and
More informationClinical qualification of specifications - a Regulator s view
Clinical qualification of specifications - a Regulator s view Mats Welin Medical Products Agency, Uppsala, Sweden Disclaimer: The opinions expressed are my own and do not necessarily represent those of
More informationSTABILITY: STABILITY TESTING OF NEW VETERINARY DRUG SUBSTANCES (REVISION)
VICH GL3(R) (QUALITY) January 2007 Revision at Step 9 For Implementation at Step 7 STABILITY: STABILITY TESTING OF NEW VETERINARY DRUG SUBSTANCES (REVISION) Recommended for Adoption at Step 7 of the VICH
More informationGuidelines for Process Validation of Pharmaceutical Dosage Forms
Guidelines for Process Validation of Pharmaceutical Dosage Forms Version 2.1 Date issued 21/02/2010 Date of implementation 21/05/2010 31 August 2010 Page 1 of 20 Guidelines for Process Validation of Pharmaceutical
More informationINVESTIGATE OOT AND OOS IN STABILITY STUDIES
INVESTIGATE OOT AND OOS IN STABILITY STUDIES Kim Huynh-Ba Executive Director Pharmalytik LLC www.pharmalytik.com BIOGRAPHY Kim Huynh-Ba has over 25 years of experience in analytical development, project
More informationGuidance for Industry
Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products Center for Drug Evaluation and Research (CDER) Center
More informationDrug Product Comparability: Using Process and Product Knowledge for Successful Comparability Exercises
Drug Product Comparability: Using Process and Product Knowledge for Successful Comparability Exercises Jamie Moore Head, Late Stage Pharmaceutical Development CMC Strategy Forum July 18-19, 2016 Many Reasons
More informationFederal Institute for Drugs and Medical Devices ICH-Leitlinie Q 8 - Pharmaceutical Development die regulatorische Perspektive
ICH-Leitlinie Q 8 - Pharmaceutical Development die regulatorische Perspektive Dr. Susanne Keitel Swiss Association for Quality Olten, 28. Juni 2006 1 Overview of the Presentation ICH Q 8: background and
More informationRegistered Starting Material Auditing Guide
Registered Starting Material Auditing Guide Annex 1 Aide Mémoire Company : Auditor(s) : Location, Country : Date of Audit: APIC Guide for Auditing Registered Starting Material Manufacturers Remark: Non-compliance
More informationGMPs for Method Validation in Early Development: An Industry Perspective (Part II)
GMPs for Method Validation in Early Development: An Industry Perspective (Part II) Pharmaceutical Technology Volume 36, Issue 7, pp. 76-84 Henrik T. Rasmussen, Vertex Pharmaceuticals, Inc. Donald Chambers,
More informationCRITICAL ASPECT ANALYTICAL TEST REVIEW
CRITICAL ASPECT ANALYTICAL TEST REVIEW Jakarta 14 December 2017 Speaker: HERU PURNOMO, ST QC WORK FLOW Start Sample Received (In-Process & Finished Good) Testing Review Lab Result Yes No Non Conformance
More informationGuideline for Technology Transfer (Draft)
Guideline for Technology Transfer (Draft)English version 1 for information only 04/03/12 Scientific Research Granted by the Ministry of Health, Labor and Welfare in 2003 Research on Current Quality System
More informationExamples of regulatory expectations for analytical characterization and testing
Examples of regulatory expectations for analytical characterization and testing AT Europe 2016, 18 March 2016 Vicki Venizelos Quality RA B.V. Leiden, the Netherlands Overview What are the regulatory expectations?
More informationGUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS
PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS PH 1/97 (Rev. 3), 15 January 2002 ANNEX 15 QUALIFICATION AND
More informationPerspectives on Method Validation: Importance of Adequate Method Validation
Perspectives on Method Validation: Importance of Adequate Method Validation Heather Bridwell, Vikas Dhingra, Daniel Peckman, Jennifer Roark and Thomas Lehman The appropriate validation of analytical methods
More informationIncremental GMPs. Presented by: Karen S. Ginsbury For: IFF October 31, Nov 02, PCI Pharmaceutical Consulting Israel Ltd.
Incremental GMPs Presented by: Karen S. Ginsbury For: IFF October 31, Nov 02, 2017 1/55 Sound Science Good Development Practice Traceability R&D Tox I II III IV What You Need Here Can t be generated here
More information