Microbiology and Auditing. Don Singer

Size: px
Start display at page:

Download "Microbiology and Auditing. Don Singer"

Transcription

1 Microbiology and Auditing Don Singer ASQ Northeast Pharmaceutical GMP/Quality Conference 2011

2 Through the eyes of a Microbiologist

3 Microbiology Audit = Inspection / Investigation

4 Systematic Auditing Planning Right People Tools Appropriate Objectives

5 Auditing approach Corporate design or policy Team Independent

6 Purpose Quality Systems Build robustness into your quality systems cgmps

7 Types of audits with Evaluation of Microbiological control Contract manufacture Contract microbiology laboratory Excipient manufacturer Active ingredient manufacturer Combination of any of the above Internal manufacture or laboratory

8 Quality Systems Inspection Quality system Production system Laboratory controls system Materials system Packaging and labeling system Facilities and equipment system

9 Microbiological Quality Risk Dosage form Management Laboratory tests Materials management

10 Risk by route of administration High Parenteral Ophthalmic Otic Wound topicals Nebulizer solution Intranasal solution Inhaled - DPI Inhaled - MDI Low Topical cream Topical ointment Oral solutions, suspensions Liquid-filled capsules Tablet, Capsule

11 Lab tests risk from impact of results High Sterility Test Bacterial endotoxin test Antimicrobial Preservatives Effectiveness Test Biological assays Microbial enumeration and Specified microorganisms tests Microbial identification Media growth promotion Low

12 Materials risk of contamination Manufacturing process Unprocessed High Classification Animal or plant origin (e.g. lactose) Highly processed Mineral origin (e.g. Talc) Some bioburden reduction processing Semi-synthetic origin (e.g. captisol, HPM) Mineral origin (e.g. dyes, aromatics) Low Synthetic origin (e.g. povidone)

13 Audit Expertise What is a QC Microbiologist? Knowledge Base : Science Origin and Growth Control

14 Microbiological Science

15 Origin and Growth Water (H 2 O) Nutrition (CHO, CHON, CHOOH, minerals, etc.) Presence or absence of components of air

16 Other Growth Factors ph temperature osmotic conditions light

17 Microbial Origin and Survival moderate to extreme environments solid to liquid dense to dilute atmosphere, humans and other living organisms (animals - vegetation), water, soil

18 Role of a QC Microbiologist Design for microbiological control Monitor to continuously evaluate

19 Control How to manipulate the environment Understand microbial growth limitations Determine how to reduce or eliminate microbial growth Understand dynamics of environment and microbiological growth / survival

20 Understand Thoroughly? Do you have the appropriate background and experience for microbiological investigation? If you do not, then partner with a Microbiologist

21 Tools to Assist cgmps, guidance docs, pharmacopeias Quality tools such as

22 Useful Quality Tools Assessment checklist or survey (developed by your Microbiologist colleague)

23

24 How does Risk fit Inspection decisions? High risk on-site inspection mandatory Moderate risk questionnaire assessment or on-site inspection Low risk questionnaire

25 Process flow chart Release of raw materials Fermentation Centrifugation Chromatography Bulk substance Filtration Final packaged product

26 Process analysis Excipients and Water Micronization Separation Drying Water Hydration Sterile filtration Filling

27 Details of Process with Controls HACCP plan Perform a virtual HACCP analysis using tour, procedures and assessment survey Amount of detail depends on level of risk

28 Audit Findings Template Same document format as Lead auditor Or Modified document for notes during audit For efficiency and clarity. Agreed on format with Lead auditor

29 Objectives I perform an audit with these intended goals: 1. Determine quality systems in place for microbiological control 2. Determine level of knowledge and capabilities of audited site 3. Determine if continuous improvement is part of culture

30 Objectives (cont.) 4. Determine if culture matches ours 5. Share knowledge and perspective with client where adds value 6. Develop a relationship based on respect, shared learning, communications

31 Right People Participants To ensure that adequate and timely information is generated during an audit Questions should be directed to the Microbiologist who has accountability and responsibility, and possibly to their staff Additionally, communicate with operators, or validation scientists, if appropriate (e.g. for sterile operations)

32 Success or Failure The results from an audit depend on the accuracy of information A non-microbiologist should have effective access to someone who is educated in pharmaceutical microbiology

33 Virtual Audit with a Microbiology Auditor

34 Criteria to Consider for Manufacturing Audits Excipient control C of A, specs, QC testing, material storage, weighing Process flow containment, gowning Process equipment validation, cleaning, sterilization, microbial monitoring Process areas cleaning, sanitization, access control, gowning, gloves, microbial monitoring, classification qualification Source of water, water system control and monitoring

35 Criteria to Consider for Manufacturing Audits Formulation excipient and component handling, bulk material handling, in-process sampling, hold time qualifications Dosage dependent manufacture controls (e.g. mixing, drying, milling, compaction) Finish/fill operations sampling, cleaning, operator technique/intervention, controls (e.g. filtration, sterilization, closure control), process qualification Finished product QC testing, stability testing

36 Criteria to Consider for Laboratory Audits Organization and reporting structure Laboratory layout Sample tracking, storage Media control, made or purchased Supplies, reagents control Instrument control calib., PM Lab and instrument cleaning, disinfection

37 Criteria to Consider for Laboratory Audits Lab monitoring SOPs and their control Microbial identification process Exceeded limit or atypical result procedure Quality improvement program, measures Proficiency testing Test methodology Method suitability procedures

38 Criteria to Consider for API or Excipient Manufacture Audit Process flow and contributing factors (e.g. intended use of compound, parenteral vs. non-sterile) Monitoring of process Origin and control of raw ingredients Water system control and monitoring Microbial monitoring of product

Basic Understanding of Good Manufacturing Practices Requirements and Execution. Minda Chiang Hong Kong Society for Quality Jan 2006

Basic Understanding of Good Manufacturing Practices Requirements and Execution. Minda Chiang Hong Kong Society for Quality Jan 2006 Basic Understanding of Good Manufacturing Practices Requirements and Execution Minda Chiang Hong Kong Society for Quality Jan 2006 1 Outline 1 To know why GMP 2 To know what GMP is 3 To know how to comply

More information

USP <1115> Bio-burden Control of Non-sterile Drug Substances and Products. Leonard W. Mestrandrea, PhD., RM(NRM) Mestrandrea Consulting

USP <1115> Bio-burden Control of Non-sterile Drug Substances and Products. Leonard W. Mestrandrea, PhD., RM(NRM) Mestrandrea Consulting USP Bio-burden Control of Non-sterile Drug Substances and Products Leonard W. Mestrandrea, PhD., RM(NRM) Mestrandrea Consulting Disclaimer I am an independent consultant. I have been involved with

More information

Current Good Manufacturing Practice for PET Drugs - CGMP 21 CFR 212

Current Good Manufacturing Practice for PET Drugs - CGMP 21 CFR 212 Current Good Manufacturing Practice for PET Drugs - CGMP 21 CFR 212 CDER Office of Regulatory Policy Jane Axelrad, JD CDER Office of Compliance Brenda Uratani, Ph.D. CDER ONDQA Ravindra Kasliwal, Ph.D.

More information

C 5. chemical development contract research custom synthesis cgmp API manufacturing commercial production. Welcome to

C 5. chemical development contract research custom synthesis cgmp API manufacturing commercial production. Welcome to C 5 chemical development contract research custom synthesis cgmp API manufacturing commercial production Welcome to ChemCon Company profile Company profile ChemCon offers outstanding chemical services

More information

Understanding USP 797

Understanding USP 797 DDK Scientific, Corp. Raul Duarte June 2008 Copyright DDK Scientific, Corp. 2008, 2009 DDK Scientific, Corp. Proprietary The purpose of USP 797 is to prevent harm and fatality to patients that could result

More information

Microbiological Food Testing Services

Microbiological Food Testing Services Microbiological Food Testing Services the MiL, Inc. MICROBE INOTECH LABORATORIES, INC. Food Safety & Testing Services Routine Microbiology The MiL, Inc. routinely performs rapid microbial identifications,

More information

Journal of Chemical and Pharmaceutical Research

Journal of Chemical and Pharmaceutical Research Available on line www.jocpr.com Journal of Chemical and Pharmaceutical Research ISSN No: 0975-7384 CODEN(USA): JCPRC5 J. Chem. Pharm. Res., 2011, 3(2):892-898 World Health Organization s Guidelines for

More information

Course Curriculum for Master Degree in Pharmaceutical Quality Control

Course Curriculum for Master Degree in Pharmaceutical Quality Control Course Curriculum for Master Degree in Pharmaceutical Quality Control The Master Degree in Pharmaceutical Quality Control is awarded by the Faculty of Graduate studies at Jordan University of Science and

More information

World Health Organization Prequalification of Medicines

World Health Organization Prequalification of Medicines Dr André van Zyl World Health Organization Prequalification of Medicines Manufacturers meeting April 2011 Head of Inspections vanzyla@who.int 1 WHO GMP In this presentation: Background and Introduction

More information

FDA and the Compounding Pharmacy

FDA and the Compounding Pharmacy FDA and the Compounding Pharmacy Scott Sutton, Ph.D. scott.sutton@microbiol.org 41 Overview of Presentation The Recent Events GCP and GMP Basics the 483 Review H.R. 3204 Outsourcing Facility Preparation

More information

Industrial Pharmaceutical Regulation. Dr. Deny Susanti

Industrial Pharmaceutical Regulation. Dr. Deny Susanti Industrial Pharmaceutical Regulation Dr. Deny Susanti Course Outline Course objective This course is designed to provide understanding on the aspects of drug manufacturing, which encompasses the processes

More information

DISCUSSION TOOL PRESENTED TO THE AABB CT REGULATORY AFFAIRS SUBSECTION

DISCUSSION TOOL PRESENTED TO THE AABB CT REGULATORY AFFAIRS SUBSECTION 1 US FDA Form 483: A Case Study DISCUSSION TOOL PRESENTED TO THE AABB CT REGULATORY AFFAIRS SUBSECTION DEVELOPED BY FRAN RABE 2 Introduction This case study is intended to extract portions of information

More information

Current Good Manufacturing Practices Checklist For Pharmaceutical Manufacturers

Current Good Manufacturing Practices Checklist For Pharmaceutical Manufacturers Current Good Manufacturing Practices Checklist For Pharmaceutical Manufacturers Current Good Manufacturing Practices ( cgmps or GMPs ) for pharmaceutical manufacturers provide the methods and controls

More information

HOMEOPATHIC MEDICINAL PRODUCT WORKING GROUP (HMPWG) GUIDANCE ON MODULE 3 OF THE HOMEOPATHIC MEDICINAL PRODUCTS DOSSIER

HOMEOPATHIC MEDICINAL PRODUCT WORKING GROUP (HMPWG) GUIDANCE ON MODULE 3 OF THE HOMEOPATHIC MEDICINAL PRODUCTS DOSSIER HOMEOPATHIC MEDICINAL PRODUCT WORKING GROUP (HMPWG) GUIDANCE ON MODULE 3 OF THE HOMEOPATHIC MEDICINAL PRODUCTS DOSSIER DISCUSSION IN THE HMPWG 2003-2005 RELEASE FOR CONSULTATION December 2005 DEADLINE

More information

Current Issues Regarding Sterility Assurance Submissions for Sterile Generic Drug Products Dr. Lynne A. Ensor

Current Issues Regarding Sterility Assurance Submissions for Sterile Generic Drug Products Dr. Lynne A. Ensor Current Issues Regarding Sterility Assurance Submissions for Sterile Generic Drug Products Dr. Lynne A. Ensor U.S. Food & Drug Administration Center for Drug Evaluation & Research Office of Pharmaceutical

More information

LIBRARY GUIDE: Pharmaceutical GMPs

LIBRARY GUIDE: Pharmaceutical GMPs LIBRARY GUIDE: Pharmaceutical GMPs Table of Contents Overview............................................................................ 3 Courses Listed by Functional Area....................................................

More information

CONCEPTS OF FOOD SAFETY QUALITY MANAGEMENT SYSTEMS. Mrs. Malini Rajendran

CONCEPTS OF FOOD SAFETY QUALITY MANAGEMENT SYSTEMS. Mrs. Malini Rajendran CONCEPTS OF FOOD SAFETY AND QUALITY MANAGEMENT SYSTEMS Mrs. Malini Rajendran Brief background 1963 - The Codex Alimentarius Commission was created by FAO and WHO to develop food standards, guidelines and

More information

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP)

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP) The European Agency for the Evaluation of Medicinal Products London, May 2002 CPMP/QWP/158/01 Revision EMEA/CVMP/115/01 Revision COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY

More information

The Microbial Bioburden of USP 797 Compliance. Simplifying Environmental Quality and Control Practices for Pharmaceutical Compounding

The Microbial Bioburden of USP 797 Compliance. Simplifying Environmental Quality and Control Practices for Pharmaceutical Compounding The Microbial Bioburden of USP 797 Compliance Simplifying Environmental Quality and Control Practices for Pharmaceutical Compounding PathCon Laboratories Fall 2009 Table of Contents Introduction a primer

More information

Library Guide: Pharmaceutical GMPs

Library Guide: Pharmaceutical GMPs Library Guide: Pharmaceutical GMPs Table of Contents Overview...3 Courses Listed by Functional Area... 4 Course Descriptions: A Step-by-Step Approach to Process Validation (PHDV79)... 7 A Tour of the FDA

More information

Hazard Analysis and Critical Control Points (HACCP) 1 Overview

Hazard Analysis and Critical Control Points (HACCP) 1 Overview Manufacturing Technology Committee Risk Management Working Group Risk Management Training Guides Hazard Analysis and Critical Control Points (HACCP) 1 Overview Hazard Analysis and Critical Control Point

More information

Title:: Effective GMP AUDITS for APIs and Formulation Pharma Companies By G.Sundar-Director/Consultant PharmQA Compliance solutions

Title:: Effective GMP AUDITS for APIs and Formulation Pharma Companies By G.Sundar-Director/Consultant PharmQA Compliance solutions WELCOME Title:: Effective GMP AUDITS for APIs and Formulation Pharma Companies By G.Sundar-Director/Consultant PharmQA Compliance solutions Contents: Introduction GMP Audit GMP Audit plan GMP Auditing

More information

Opinions expressed in this presentation are those of the speaker and do not necessarily reflect the views or policies of the FDA

Opinions expressed in this presentation are those of the speaker and do not necessarily reflect the views or policies of the FDA Opinions expressed in this presentation are those of the speaker and do not necessarily reflect the views or policies of the FDA Generic Drugs Application and Regulatory Review Naiqi Ya, Ph.D. Deputy Director

More information

Leila Kakko Tampere University of Applied science TRADITIONAL FOOD IN COMBATING FOODBORNE PATHOGENS 2011

Leila Kakko Tampere University of Applied science TRADITIONAL FOOD IN COMBATING FOODBORNE PATHOGENS 2011 Leila Kakko Tampere University of Applied science TRADITIONAL FOOD IN COMBATING FOODBORNE PATHOGENS 2011 World Food Programme Food quality control is necessary to ensure that food aid supplies are safe,

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Changes to an Approved NDA or ANDA U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) April 2004 CMC Revision

More information

Guidance for Industry: Starting Material Supplier Management

Guidance for Industry: Starting Material Supplier Management Guidance for Industry: Starting Material Supplier Management Version 1.0 Drug Office Department of Health. Contents 1. Introduction... 3 2. Purpose of this document... 3 3. Scope... 3 4. Selecting and

More information

Guidelines for drafting a Site Master File (SMF)

Guidelines for drafting a Site Master File (SMF) Guidelines for drafting a Site Master File (SMF) A Site Master File for each manufacturing site listed in a product dossier, must be submitted to World Health Organization, HTP/EDM/QSM, 20 Ave Appia, 1211

More information

Catalog. Global Education. and Training. Global Expertise Trusted Standards Improved Health

Catalog. Global Education. and Training. Global Expertise Trusted Standards Improved Health Global Education Catalog 2013 2014 and Training Global Expertise Trusted Standards Improved Health USP s mission is to improve global health through public standards and related programs that help ensure

More information

Risk-Based Environmental Monitoring. Marsha Stabler Hardiman Senior Consultant Concordia ValSource Wednesday September 17, 2014 FDA/PQRI

Risk-Based Environmental Monitoring. Marsha Stabler Hardiman Senior Consultant Concordia ValSource Wednesday September 17, 2014 FDA/PQRI Risk-Based Environmental Monitoring Marsha Stabler Hardiman Senior Consultant Concordia ValSource Wednesday September 17, 2014 FDA/PQRI Presenter Marsha Stabler Hardiman Over 20 years experience in the

More information

DRAFT GUIDANCE. This guidance document is being distributed for comment purposes only.

DRAFT GUIDANCE. This guidance document is being distributed for comment purposes only. Guidance for Industry Current Good Manufacturing Practice Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act DRAFT GUIDANCE This guidance document is

More information

ICH Topic Q 1 A Stability Testing Guidelines: Stability Testing of New Drug Substances and Products

ICH Topic Q 1 A Stability Testing Guidelines: Stability Testing of New Drug Substances and Products 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

F. Y. B. Sc. Microbiology Paper II: Fundamental Methods in Microbiology

F. Y. B. Sc. Microbiology Paper II: Fundamental Methods in Microbiology F. Y. B. Sc. Microbiology Paper II: Fundamental Methods in Microbiology Chapter 1: Microscopy Q. 12 marks each 1. What is aberration? Explain different types of aberrations. 2. What is microscope? Explain

More information

Understanding and predicting product shelf-life. Dr. Mathias Kramer

Understanding and predicting product shelf-life. Dr. Mathias Kramer Understanding and predicting product shelf-life Dr. Mathias Kramer Purpose of Stability Testing What affects Stability? Evaluation of Stability Data Reasonable Stability Testing Conclusion Purpose of Stability

More information

Guide to Registration of Homeopathic Medicinal Products

Guide to Registration of Homeopathic Medicinal Products Guide to Registration of Homeopathic Medicinal Products AUT-G0037-4 12 November 2014 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only. CONTENTS

More information

TABLE OF CONTENTS CHAPTER 13 NON-STERILE COMPOUNDING

TABLE OF CONTENTS CHAPTER 13 NON-STERILE COMPOUNDING TABLE OF CONTENTS CHAPTER 13 NON-STERILE COMPOUNDING Section 1. These regulations are promulgated as authorized by the Act.... 1 Section 2. Definitions.... 1 Section 3. General Provisions.... 2 Section

More information

On-Site GMP Training GMP COMPLIANCE TECHNICAL

On-Site GMP Training GMP COMPLIANCE TECHNICAL PharmaNet On-Site GMP Training GMP COMPLIANCE TECHNICAL 284 E Lake Mead Pkwy Suite C-278 Henderson, NV 89015 Phone: 702-558-0094 Fax: 702-558-0079 www.gmpseminars.com Key to Level of Program Level A: Program

More information

Manufacturing and Compounding of Medications

Manufacturing and Compounding of Medications Manufacturing and Compounding of Medications Version 1.1 1 September 2010 Page 1 of 3 Manufacturing and Compounding of Medications Version 1.1 Drug Sector Saudi Food & Drug Authority Kingdom of Saudi Arabia

More information

Current GMP Guidelines

Current GMP Guidelines Introduction is a system for ensuring that products are consistently produced and controlled according to the quality standards. It is designed to minimize the risks involved in any pharmaceutical production

More information

Content. 01 Introduction p 3

Content. 01 Introduction p 3 Biological Safety Testing of Cosmetics Content 01 Introduction p 3 02 Biocompatibility p 5 Cytotoxicity p 5 Genotoxicity p 5 Skin Corrosion p 6 Skin Irritation p 6 Skin Sensitization p 7 Eye Irritation

More information

Preparing for the Pre-Approval Inspection What to do Before the FDA Arrives. Barry A. Friedman, Ph.D. Consultant

Preparing for the Pre-Approval Inspection What to do Before the FDA Arrives. Barry A. Friedman, Ph.D. Consultant Preparing for the Pre-Approval Inspection What to do Before the FDA Arrives Barry A. Friedman, Ph.D. Consultant FDA Overview FDA is a consumer protection agency within the Department of Health & Human

More information

Manual 066 Requirements for Facilities For Sterile and Non-sterile Drug Manufacture

Manual 066 Requirements for Facilities For Sterile and Non-sterile Drug Manufacture 1 Purpose The purpose of this Guideline is to describe the requirements for meeting current Good Manufacturing Practice (cgmp) compliance requirements for new and upgraded facilities to be used for the

More information

A Process Verification Model Quality Assurance in a Compounding Pharmacy

A Process Verification Model Quality Assurance in a Compounding Pharmacy ba ic f c mp unding quali y-c n l analy ical me d p e c ip i n A Process Verification Model calcula for i n Quality Assurance in a ma ke ing Compounding Pharmacy Abstract There are virtually thousands

More information

How to overcome Non compliance (483) related To manufacturing of Drug Products and observations Found during the audits?

How to overcome Non compliance (483) related To manufacturing of Drug Products and observations Found during the audits? How to overcome Non compliance (483) related To manufacturing of Drug Products and observations Found during the audits? IPA Maharashtra Seminar at SciTech Centre Jogeshwari Mumbai on 31.01.2014 By Sudhir

More information

HAZARD ANALYSIS CRITICAL CONTROL POINT PLAN SUMMARY SETHNESS PRODUCTS COMPANY LIQUID CARAMEL COLOR

HAZARD ANALYSIS CRITICAL CONTROL POINT PLAN SUMMARY SETHNESS PRODUCTS COMPANY LIQUID CARAMEL COLOR HAZARD ANALYSIS CRITICAL CONTROL POINT PLAN SUMMARY SETHNESS PRODUCTS COMPANY LIQUID CARAMEL COLOR I. INTRODUCTION A. CARAMEL COLOR 1. Caramel Color (Caramel) is defined in Title 21 of the U.S. Code of

More information

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP)

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) <DRAFT> The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use London, 20 February 2003 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR GUIDANCE

More information

MeriCal Quality Profile

MeriCal Quality Profile January 5, 2015 Dear Valued Customer, Since the implementation of new federal regulations, MeriCal Inc. has received a large volume of questionnaires and surveys regarding our services and procedures.

More information

White Spots on Tablets Compliance Case Study #8

White Spots on Tablets Compliance Case Study #8 White Spots on Tablets Compliance Case Study #8 Paul L. Pluta IMAGEZOO/GETTY IMAGES Compliance Case Studies discusses compliance situations useful to practitioners in compliance and validation. Each case

More information

Excipients 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 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

Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products

Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products Questions and Answers U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation

More information

GMP Inspection report

GMP Inspection report Inspected site(s): Activities Carried out: GMP Inspection report Manufacture of Active Substance Manufacture of Finished Medicinal Product Packaging Importing Laboratory Testing Batch Control and Batch

More information

Annex 7 Guidelines on pre-approval inspections

Annex 7 Guidelines on pre-approval inspections World Health Organization WHO Technical Report Series, No. 902, 2002 Annex 7 Guidelines on pre-approval inspections 1. General 94 2. Glossary 94 3. Objectives 95 4. Priorities 96 5. Preparation for the

More information

Guidance for Industry

Guidance for Industry Guidance for Industry CGMP for Phase 1 Investigational Drugs U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics

More information

Xiaoming Wang, MD. MS. Manager QC Microbiology ImClone Systems A wholly-owned subsidiary of Eli-Lilly and Company

Xiaoming Wang, MD. MS. Manager QC Microbiology ImClone Systems A wholly-owned subsidiary of Eli-Lilly and Company Xiaoming Wang, MD. MS Manager QC Microbiology ImClone Systems A wholly-owned subsidiary of Eli-Lilly and Company USP Microbiological Best Laboratory Practices USP 32 page 616 Introduction: good laboratory

More information

Read the Questions Carefully

Read the Questions Carefully PHT. 463- (Quality Control of Pharmaceutical Dosage Forms) Midterm Exam I Dr. Ibrahim A. Alsarra s Section Part I Read the Questions Carefully TRUE OR FALSE: Indicate whether the statement is true or false

More information

cgmp Challenges for Cord Blood Banks

cgmp Challenges for Cord Blood Banks cgmp Challenges for Cord Blood Banks Donna M. Regan, MT(ASCP)SBB St. Louis Cord Blood Bank @ SSM Cardinal Glennon Children s s Medical Center Cord Blood Bank processing facility challenges What does cgmp

More information

ANDA CHECKLIST FOR CTD or ectd FORMAT FOR COMPLETENESS and ACCEPTABILITY of an APPLICATION FOR FILING

ANDA CHECKLIST FOR CTD or ectd FORMAT FOR COMPLETENESS and ACCEPTABILITY of an APPLICATION FOR FILING 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

Guidance for Industry

Guidance for Industry Guidance for Industry INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation

More information

QC Micro Webinar Series. Amylin's Improved Aseptic Gowning and Monitoring Program Using MODA Solution

QC Micro Webinar Series. Amylin's Improved Aseptic Gowning and Monitoring Program Using MODA Solution QC Micro Webinar Series Amylin's Improved Aseptic Gowning and Monitoring Program Using MODA Solution Rapid Testing Solutions / Lonza / 07 Jun 2011 Today s Presenters Bob Toal Segment Manager, Informatics

More information

Guideline on Process Validation

Guideline on Process Validation 1 2 3 4 29 March 2012 EMA/CHMP/CVMP/QWP/70278/2012-Rev1 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) 5 6 Draft Draft Agreed by CHMP /

More information

Overview of Cleaning Validation in Pharmaceutical Industry

Overview of Cleaning Validation in Pharmaceutical Industry Available online at www.ijpqa.com International Journal of Pharmaceutical Quality Assurance 2010; 2(2), 26-30 Review Article ISSN: 0975-9506 Overview of Cleaning Validation in Pharmaceutical Industry Anindya

More information

Highly Potent APIs The right platform, people and procedures for successful development and manufacturing

Highly Potent APIs The right platform, people and procedures for successful development and manufacturing Pharma&Biotech Highly Potent APIs The right platform, people and procedures for successful development and manufacturing Custom Manufacturing and Development Services for Highly Potent APIs Pharma&Biotech

More information

Quality Systems Appropriate for Extemporaneously Prepared Early Phase Clinical Trial Materials. Agenda Topics for Discussion

Quality Systems Appropriate for Extemporaneously Prepared Early Phase Clinical Trial Materials. Agenda Topics for Discussion Quality Systems Appropriate for Extemporaneously Prepared Early Phase Clinical Trial Materials Richard Hoffman, MS Eli Lilly & Co. Principal Consultant - Regulatory PDA/FDA Joint September 20 th, 2011

More information

Process filtration Adding value to your business

Process filtration Adding value to your business Process filtration Adding value to your business Parker domnick hunter specializes in the manufacture and supply of high quality products for the clarification, stabilization and sterilization of liquids

More information

Pharmaceutical Industry Trends Approaches to Process Validation and Risk Management (Quality Systems and cgmps)

Pharmaceutical Industry Trends Approaches to Process Validation and Risk Management (Quality Systems and cgmps) Pharmaceutical Industry Trends Approaches to Process Validation and Risk Management (Quality Systems and cgmps) Anita R. Michael, Pharmaceutical Specialist FDA Office of Regulatory Affairs 1 Process Validation

More information

Annex 6. Guidance on variations to a prequalified product dossier. Preface

Annex 6. Guidance on variations to a prequalified product dossier. Preface Annex 6 Guidance on variations to a prequalified product dossier Preface This guidance document was technically and structurally inspired by the Guideline on dossier requirements for type IA and IB notifi

More information

Cleaning Validation in the Pharmaceutical Industry

Cleaning Validation in the Pharmaceutical Industry Cleaning Validation in the Pharmaceutical Industry By Mowafak Nassani, Ph.D. INTRODUCTION Cleaning validation in the pharmaceutical industry has been a topic of ever-increasing interest and scrutiny in

More information

Manufacturing process of biologics

Manufacturing process of biologics Manufacturing process of biologics K. Ho Afssaps, France 2011 ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 2011 ICH 1 Disclaimer:

More information

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION

More information

Risk-Based Validation and Requalification of Processes & Equipment. Nancy Tomoney Associate Validation Manager QPharma Inc.

Risk-Based Validation and Requalification of Processes & Equipment. Nancy Tomoney Associate Validation Manager QPharma Inc. Risk-Based Validation and Requalification of Processes & Equipment Nancy Tomoney Associate Validation Manager QPharma Inc. Order of Operations US Predicate law always comes first US Guidances Other non

More information

Department of Food Science Food Processing FSE98(10-99)

Department of Food Science Food Processing FSE98(10-99) Department of Food Science Food Processing FSE98(10-99) Choosing and Using a Copacker John E. Rushing, Ph.D. What is a copacker? Copackers manufacture and package foods for other companies to sell. These

More information

Guideline for Technology Transfer

Guideline for Technology Transfer Guideline for Technology Transfer 1. Preface 1.1 Background According to the revised Japanese Pharmaceutical Affairs Law in July 2003, the manufacturing approval system has been replaced with the manufacturing

More information

Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers

Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center

More information

REVISION OF MONOGRAPH ON CAPSULES. Capsules

REVISION OF MONOGRAPH ON CAPSULES. Capsules March 2011 REVISION OF MONOGRAPH ON CAPSULES Final text for addition to The International Pharmacopoeia This monograph was adopted by the Forty-fourth WHO Expert Committee on Specifications for Pharmaceutical

More information

Certification. Our Vision. About Us

Certification. Our Vision. About Us Certification Good Manufacturing Practice Natural Products Association GMP Certified TGA Health Safety Regulation Health Canada PIC/S GMP Halal Certified Ministry of Health Brunei Darussalam World Health

More information

Supply Chain Challenges and Risk Management

Supply Chain Challenges and Risk Management Supply Chain Challenges and Risk Management Presented by Steve Williams Director SeerPharma P/L 21 st April 2009 PDA April 09 SW 1 Supply Chain - Some Useful Guidance cgmp Annex 8 cgmp Chapter 7 ICH Q7

More information

GMP Pharma BV. Netherlands

GMP Pharma BV. Netherlands GMP Pharma BV Netherlands Connecting the European & Indian Pharmaceutical, Biotechnology and Biopharmaceutical Industry for parallel growth and solicitation. About Us: GMP Pharma BV is a multisource organization

More information

2014 Annual Report on Inspections of Establishments

2014 Annual Report on Inspections of Establishments 2014 Annual Report on Inspections of Establishments Table of Contents Introduction... 2 Data Collection and Definitions... 3 Section 510(h)(6)(A)(i) Number of Domestic and Foreign Establishments Registered

More information

Cleanroom. For. Sterile Manufacturing Facilities

Cleanroom. For. Sterile Manufacturing Facilities Cleanroom For Sterile Manufacturing Facilities Praphon Angtrakool Food and Drug Administration 1 WHO TRS No. 823 Annex 1, 1992 (1) General 17.1 The production of sterile preparations should be carried

More information

FDA/Xavier PharmaLink Conference, March 2015

FDA/Xavier PharmaLink Conference, March 2015 Who just walked through my door? Chris Middendorf, FDA/ORA - Cincinnati District Overview o Basic requirements of a Consumer Safety Officer o Commodity specific training o Drug investigator certification

More information

The XDS Near-Infrared Product Line from FOSS Cost-Effective, Efficient and Reliable

The XDS Near-Infrared Product Line from FOSS Cost-Effective, Efficient and Reliable Near-Infrared Product Line from FOSS Cost-Effective, Efficient and Reliable FOSS: The Standard for Dedicated NIR Analysis FOSS is the world leading supplier of near-infrared (NIR) products and services.

More information

Questionnaire Layout:

Questionnaire Layout: Raw Material Supplier Questionnaire Introduction: This questionnaire has been developed by the EHPM quality working group. It combines work carried out by EHPM various national associations in developing

More information

Step-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry

Step-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry Step-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry BY GHULAM A. SHABIR Introduction Methods Validation: Establishing documented evidence that provides a high

More information

Bioequivalence and Drug Product Quality

Bioequivalence and Drug Product Quality Bioequivalence and Drug Product Quality Vinod P. Shah, Ph. D. FIP/SIG Chair, Regulatory Sciences Pharmaceutical Consultant (Formerly with US FDA) 2 nd MENA Conference on Bioequivalence, Biowaivers, Bioanalysis,

More information

Basic Microbiology. By the end of this chapter, you will be able to: Introduction. What are Micro-organisms? Chapter 3

Basic Microbiology. By the end of this chapter, you will be able to: Introduction. What are Micro-organisms? Chapter 3 Chapter 3 Basic Microbiology By the end of this chapter, you will be able to: l Name the types of micro-organisms that may be found in clean rooms l List the ways in which microbial contamination is carried

More information

Pharmacy Technician Training Program. Minimum Competencies

Pharmacy Technician Training Program. Minimum Competencies 1. Pharmacy Practice Pharmacy Technician Training Program Minimum Competencies 1.1 The candidate shall be familiar with the mission of pharmacy and the various permitted pharmacy practice sites. The candidate

More information

Cleaning Validation in Active pharmaceutical Ingredient manufacturing plants

Cleaning Validation in Active pharmaceutical Ingredient manufacturing plants Cleaning Validation in Active pharmaceutical Ingredient manufacturing plants September 1999 Table of contents 1. Foreword...... 2 2. Objective...... 3 3. Scope........ 4 4. Potential residues... 5 5. Current

More information

DETERMINATION OF PRESERVATION EFFICACY IN WATER-MISCIBLE PERSONAL CARE PRODUCTS

DETERMINATION OF PRESERVATION EFFICACY IN WATER-MISCIBLE PERSONAL CARE PRODUCTS DETERMINATION OF PRESERVATION EFFICACY IN WATER-MISCIBLE PERSONAL CARE PRODUCTS INTRODUCTION Many personal care products provide conditions that are conducive to microbial growth such as water, nutrients,

More information

Annex 2 Stability testing of active pharmaceutical ingredients and finished pharmaceutical products

Annex 2 Stability testing of active pharmaceutical ingredients and finished pharmaceutical products World Health Organization WHO Technical Report Series, No. 953, 2009 Annex 2 Stability testing of active pharmaceutical ingredients and finished pharmaceutical products 1. Introduction 1.1 Objectives of

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE PHARMACEUTICAL QUALITY OF INHALATION AND NASAL PRODUCTS

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE PHARMACEUTICAL QUALITY OF INHALATION AND NASAL PRODUCTS European Medicines Agency Inspections London, 21 June 2006 Doc Ref.: EMEA/CHMP/QWP/49313/2005 Corr COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE PHARMACEUTICAL QUALITY OF INHALATION

More information

JANUARY 2013 PREPARATION OF A SITE MASTER FILE FOR A MANUFACTURER OF COSMETIC PRODUCTS

JANUARY 2013 PREPARATION OF A SITE MASTER FILE FOR A MANUFACTURER OF COSMETIC PRODUCTS JANUARY 2013 PREPARATION OF A SITE MASTER FILE FOR A MANUFACTURER OF COSMETIC PRODUCTS 1 WHAT IS A SITE MASTER FILE? A Site Master File (SMF) is a document prepared by the manufacturer containing specific

More information

FILTRATION SOLUTIONS PhARmAceUTIcAL manufacturing FILTRATION SPecIALISTS

FILTRATION SOLUTIONS PhARmAceUTIcAL manufacturing FILTRATION SPecIALISTS FILTRATION SOLUTIONS Pharmaceutical Manufacturing filtration specialists Delivering quality filtration products As one of Europe s leading manufacturers of process filters, Amazon Filters is able to offer

More information

PLASTIC PRIMARY PACKAGING MATERIALS

PLASTIC PRIMARY PACKAGING MATERIALS PLASTIC PRIMARY PACKAGING MATERIALS Guideline Title Plastic Primary Packaging Materials Legislative basis Directive 75/318/EEC as amended Date of first adoption February 1994 Date of entry into August

More information

Quality Agreement. by and between. Supplier Name. Address: and. Client Name: Address:

Quality 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 information

For all other applications, including new applications, please visit

For all other applications, including new applications, please visit This content only applies to transition applications that were received before 1 July 2014. The content will be relevant for these applications until 30 June 2015. For all other applications, including

More information

Guideline for the Stability Testing in Support of Changes to Nonprescription (OTC) Monograph Drug Products Not Regulated by an NDA/ANDA

Guideline for the Stability Testing in Support of Changes to Nonprescription (OTC) Monograph Drug Products Not Regulated by an NDA/ANDA Guideline for the Stability Testing in Support of Changes to Nonprescription (OTC) Monograph Drug Products Not Regulated by an NDA/ANDA INTRODUCTION Due to the great variety of changes that may be encountered

More information

Global Lab Capabilities Pharma Biotech

Global Lab Capabilities Pharma Biotech Global Lab Capabilities Pharma Biotech NSF Health Sciences global network of laboratories delivers expert solutions to pharmaceutical, biotechnology and medical device companies in the areas of analytical

More information

RESOLUTION-RDC Nr- 48, OF OCTOBER 6, 2009

RESOLUTION-RDC Nr- 48, OF OCTOBER 6, 2009 RESOLUTION-RDC Nr- 48, OF OCTOBER 6, 2009 This resolution provides for the alteration, inclusion, suspension, reactivation and cancellation after registration of medications and sets forth other provisions.

More information

Annex 9 Guide to good storage practices for pharmaceuticals 1

Annex 9 Guide to good storage practices for pharmaceuticals 1 World Health Organization WHO Technical Report Series, No. 908, 2003 Annex 9 Guide to good storage practices for pharmaceuticals 1 1. Introduction 125 2. Glossary 126 3. Personnel 128 4. Premises and facilities

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products For questions on the content of the guidance,

More information

SADC GUIDELINE FOR STABILITY TESTING

SADC GUIDELINE FOR STABILITY TESTING SADC GUIDELINE FOR STABILITY TESTING 2004 This guideline is intended to provide requirements to applicants wishing to submit applications for the registration of medicines. It represents SADC current thinking

More information