Julie Roberts. Audit hot Topics and Regulatory Requirements
|
|
- Philip Warner
- 6 years ago
- Views:
Transcription
1 Julie Roberts Audit hot Topics and Regulatory Requirements
2 Overview Hot Topics Examples in warning letters Tips to detecting data integrity Recent changes in regulatory requirements
3 Hot Topics Microbial Control Strategy EM programme Risk Assessments Investigations Insufficient investigation RC not determined Data Integrity Recording of data Second person verification Chain of custody Maintaining compliance with Regulatory changes
4 Hot Topics - Microbial Control Strategy Overall philosophy for how you control microbial contamination for your processes. May need one per type of process e.g. aseptic fill vs terminal sterilisation vs non-sterile products Microbial control strategy demonstrates you understand your process, the limitations e.g. external materials/internal processes, what needs to be controlled, what can be measured, what cannot be measured
5 Hot Topics EM Programmes EM Programmes Written rationalisation for sample location i.e. risk assessment of activities Linkage to smoke studies Linkage to operational activities (not just at rest assessments) Periodic review of the applicability/relevance of the sampling programme Appropriate and useful review of data
6 Hot Topics - Investigations Insufficient investigation Not timely hard to resolve as time passes Assumptions made preventing a full investigation Investigation report does not document all investigation activities people so close they miss to document assumptions & thought processes
7 Hot Topics Common Audit Observations Trending of EM- insufficient, too narrow, % recovery rates not used Biological indicators D-value audits or on-site determination Cleaning validation maps indicating location of swabs/samples Counting of plates second person verification/ review of data/ accuracy of result
8 Hot Topics Common Audit Observations Trending of EM- insufficient, too narrow, % recovery rates not used Biological indicators D-value audits or on-site determination Cleaning validation maps indicating location of swabs/samples Counting of plates second person verification/ review of data/ accuracy of result
9 Hot topics within Microbiology pertaining to Data Integrity
10 Canada An FDA investigator observed your microbiologist reading an environmental monitoring (personnel) plate. The microbiologist reported the result for that plate as zero; however, our FDA investigator observed one (1) colony forming unit (CFU) on the plate. Your microbiologist corrected this observation on the form XX after the FDA investigator pointed it out to him. Your firm did not take further action to investigate and determine the impact of inaccurate reporting of your microbiological plate readings on the release of your batches. Your firm failed to record the incubation dates of the microbiological plates in the validation study of the (x) of (x) for (x) Solution (x) and (x) Spray.
11 China On March 2, 2015, we observed that all 14 culture media plates in incubator #6 were dried out and cracked, which compromised microbial growth promotion and accurate enumeration. These plates were used to test multiple API batches of (b)(4). You stated that tests for microbial limits were not routine for (b)(4). The microbiologist documented test methods and results when she had time, and there was a possibility that our QC microbiologist documents results by memory instead of document (sic) at time of operation.
12 India EM results sheets show X, Y and Z samples were taken on dates [x, y, z] however review of video recording for these periods do not show such samples being taken Your active air sampler samples 1000L of air taking 5.5mins, however video recording collection of this sample shows a sample time of <3mins. Since 2005, you have been using an un-validated and unqualified Agilent data acquisition unit (DAU) to monitor the temperature of the microbiological incubation rooms for media filled vials.
13 India Finished drug product (b)(4) Tablets (b)(4)mg batches (b)(4) and (b)(4) microbial sample plates/tubes were placed in the incubators on June 19-20, 2014, as documented in your LIMS computer system. The plates should have been incubated for (b)(4) days, per your procedures. On June 23, 2014, no plates/tubes for this batch were observed in any of the incubation chambers. Finished drug product (b)(4) Tablets (b)(4) mg Exhibit Batch (b)(4) sample for microbial testing was prepared on June 13, Your firm failed to provide the FDA investigator with the worksheet to document the incubation times and media used for the analysis. Your analyst described that the entire microbial test for this batch had already been completed the previous week but that the analyst had "forgotten" to document the details on the worksheet. The FDA investigator noted other instances of missing samples/plates for in-process drug products, potable water, and growth promotion, even though records indicated that they were in the incubator.
14 Hot topics relating to Data Integrity & Data Compliance Chain of Custody Demonstration of chain of custody of EM plates WL in India/China showing fabrication of data Documented evidence for number of plates released to production, exposed, returned to lab, incubated, counted, destroyed Barcoding samples gives timing (exposure) also Logbooks can track Independence of personnel logging each stage
15 Hot topics relating to Data Integrity & Data Compliance Chain of custody (cont d) Ability to link each identification back to original plates Traceability of all activities Second person verification of counts What to verify? What to review?
16 Looking for Data Issues Notebooks, diaries, laboratory notebooks Drawers, cupboards, lockers amnesty review & clear out Review of data Are personnel trained to detect electronic edits (not just hand written edits)? Will your current reviews detect DI issues? What constitutes raw data? API strips?
17 Looking for Data Issues Equipment Controls around password/ number of licences available User access levels are they appropriate? Are they being shared? Who has more than one level of user access? Run a report of Admin log-on s check frequency Explore the Admin screen- what can be changed/ switched on/off? How many audit trails are available? Audit trails have a plan of what is reviewed, why its being reviewed, and how often you will review it.
18 Looking for Data issues Air samplers Can the sampling time be alerted/shortened? What data is the sampling machine retaining electronically (albeit transient) beyond your printout? EM programme Is your programme realistic for the number of staff? How long should it take someone to conduct all the EM required by your SOP? Are personnel completing it too quickly (same with Water Sampling)
19 Looking for Data issues Review electronic folders Do you have a policy or SOP for set up of electronic folders Check each system for atypical folder names/trial folders/project folders etc Check the waste basket on the pc when was it last emptied. What is in there?? Get IT to run activity reports from your various equipment for erroneous log-on s/ specific activity/ activity out of hours
20 Looking for Data issues Conduct random recounts of plates different days/ different personnel Review camera footage from production Operator behaviour EM & water sampler behaviour Cleaners
21 Hot topics Regulatory Updates and Changes
22 Regulatory Updates and Changes Demonstration of how you review updates to legislation Demonstration of review of applicability to your operations Implementation of the new guidance/requirements Sop to manage this process Evidence of change control to document the review, risk impact, and any changes required
23 Recent Regulatory Updates (courtesy Dr T Sandle) Production of WFI - Ph.Eur. Monograph 169 revised to include by a purification process that is equivalent to distillation. RO (single or double pass), coupled with other techniques such as EDI, UF or Nanofiltration is suitable ent_library/scientific_guideline/2016/08/wc pdf EMA Q&A provides clarification and guidance in the use of RO for manufacture of WFI, and to provide detailed guidance on the control of Biofilms
24 Regulatory Updates WHO draft guidance, Supplementary guidelines on Good Manufacturing Practices for Heating, Ventilation and Air-Conditioning Systems for Non-Sterile Pharmaceutical Dosage Forms. Scope of the document is: Solid dosage forms Covers other dosage forms (such as liquids, cream, ointments) and other classes of products including biological products, herbal medicines, complementary medicines and finishing process steps for APIs. Working document QAS/15.639/Rev.1, May /HVAC_QAS15-639_ pdf
25 Regulatory Updates EMA introduced a new draft guideline April 2016 "Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container. Steam sterilisation Dry heat sterilisation Ionisation radiation sterilisation Gas sterilisation Sterile filtration Aseptic processing ientific_guideline/2016/04/wc pdf
26 Regulatory Updates ISO14644 Part 1 updated The standard is for classification and continued testing only. It does not replace EU GMP requirements and 0.5 and 5.0 µm need to be assessed. There is a new statistical approach for the selection of the number of particle locations and the evaluation of data collected. (number of locations generally increased) With particle counter locations, to align with GMP, the location should be orientated to the point of greatest risk e.g. close to fixed equipment.
27 Regulatory Updates USP <1116> December 2013 In the most critical areas within an aseptic processing operation, it is expected that less than 1% of the samples will yield any recoverable contamination. In the most advanced of modern aseptic operations that use separative technologies such as isolators or closed RABS, the recovery rate will approach zero at all times.
28 USP<1116> Table 3. Suggested Initial Contamination Recovery Rates in Aseptic Environments a. Room Classification Isolator/Closed RABS (ISO 5 or better) Active Air Sample (%) Settle Plate (9 cm) 4 h Exposure (%) Contact Plate or Swab (%) <0.1 <0.1 <0.1 <0.1 ISO 5 <1 <1 <1 <1 ISO 6 <3 <3 <3 <3 ISO 7 <5 <5 <5 <5 ISO 8 <10 <10 <10 <10 Glove or Garment (%) A All operators are aseptically gowned in these environments (with the exception of background environments for isolators). These recommendations do not apply to production areas for nonsterile products or other classified environments in which fully aseptic gowns are not donned. Detection frequency should be based on actual monitoring data and should be re-tabulated monthly. Action levels should be based on empirical process capability. If detection frequencies exceed the recommendations in Table 3 or are greater than established process capability, then corrective actions should be taken.
29 FDA Quality Metrics Initiative Jan 13 FDA Quality Metrics programme announced in Federal Register Notice (FRN) Jun 13 IPSE started Quality Metrics Initiative Dec 13 IPSE White paper delivered to FDA Jun-Nov 14 ISPE Wave 1 Jun 15 ISPE Wave 1 report issued Jul 15 FDA Request for Quality Metrics (Draft) Lot Acceptance Rate Product Quality Complaint Rate Invalidated Out-of-Specification (OOS) Rate Annual Product Review (APR) or Product Quality Review (PQR) on Time Rate CAPA effectiveness & Process Capability & APR sign off
30 Regulatory Updates EU Annex 15 updated Oct 2015 GMP for Excipients - March 2016 EU GMP chapters 3 & 5 updated and effective March 2016 Guidance in Draft EU Annex 1 draft in discussion GMP for IMPs Final version to be published in April 2017 Date for coming into force likely October 2018 (with CTR) GMP for AT(I)MPs Public consultation recently closed; responses under assessment through October and November 2016
31 Preparing for the audit
32 Preparing for the audit Be honest with yourselves Where are the issues? Where are your weaknesses/ gaps in knowledge Any recurring issues from internal audits?
33 Preparing for the audit What is your timeline? You can t fix everything Determine what is important to you and prioritize If serious gaps cannot be addressed, look to capture them in your CAPA plan. Proof of intent is better than just intent
34 In Summary Be aware of current hot topics Be aware they can be inspector specific, agency specific! Ensure you are aware of recent changes to regulations and how they can impact you Don t let silly things catch you outcupboards/drawers/notebooks/passwords/poor compilation of validation folders Be confident - revise and know your own data & systems
35 Questions?
How to Handle Excursions in Environmental Monitoring (EM) and Personnel Monitoring (PM) in an Aseptic Processing Plant
How to Handle Excursions in Environmental Monitoring (EM) and Personnel Monitoring (PM) in an Aseptic Processing Plant Randy Hutt, Ph.D. Associate Director Sterility Assurance and Microbiology Luitpold
More informationRegulatory Update. Paul Sexton. QP Forum
Regulatory Update Paul Sexton QP Forum 16 th April, 2015 Content Updates on GMP Guidance Updates on EU Legislation Draft Ph Eur monograph on WFI including RO 2 Chapter 5 - Production Paragraphs 27 to 30
More informationGMP GUIDELINES. GMP Guides from Industry Organisations. FDA cgmp WHO GMP. cgmp Guide Drugs 21 CFR 210 GAMP. ISPE Technical Guides
FDA cgmp cgmp Guide Drugs 21 CFR 210 cgmp Guide Drugs 21 CFR 211 cgmp Guide Medical Device 21 CFR 808, 812, 820 cgmp Guide Biologics 21 CFR 600, 606, 610 Guideline List Human Drugs Guideline List Biologics
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 informationEU Guidance / Q&A. Greg McGurk, GMP Manager (acting) GMP Conference. 7 February 2017 Dublin
EU Guidance / Q&A Greg McGurk, GMP Manager (acting) GMP Conference 7 February 2017 Dublin TPN Manufacture Q&A TPN Guidance Proposed at IWG that working group be formed to draft guidance Several adverse
More informationPreparing Your Aseptic Processing Facility for an FDA Inspection. Valerie Welter, Director Quality Bayer HealthCare March 10, 2014
Preparing Your Aseptic Processing Facility for an FDA Inspection Valerie Welter, Director Quality Bayer HealthCare March 10, 2014 Agenda Regulatory Requirements Establishing your Approach Aseptic Controls
More informationUSP Chapter 823 USP 32 (old) vs. USP 35 (new)
USP Chapter 823 USP 32 (old) vs. USP 35 (new) Sally W. Schwarz, MS, BCNP Research Associate Professor of Radiology Washington University School of Medicine St. Louis, MO Why USP Chapter ? FDA has
More informationGMP Inspection Deficiencies Review of Deficiencies Observed in 2013.
GMP Inspection Deficiencies 2013 Review of Deficiencies Observed in 2013. Executive Summary The most frequently encountered defect categories raised over the previous five years have remained relatively
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 informationMicrobiology Testing: USP requirements for Sterile and Nonsterile Preparations Webinar Q&A
USP Antimicrobial Effectiveness Testing Microbiology Testing: Webinar Q&A 1. If a base ingredient is designed for the purpose of compounding a specific type of preparation does this forgo the necessity
More informationRecent USP Updates May, 2013
Recent USP Updates May, 2013 Don Singer GSK Bioburden Control of Non-sterile Drug Substances and Products The chapter emphasizes control as a risk mitigation strategy The chapter recommends a risk-based
More informationEmcure Pharmaceuticals Limited 3/3/16
1 of 7 05/06/2016 8:22 AM U.S. Food and Drug Administration Protecting and Promoting Your Health Emcure Pharmaceuticals Limited 3/3/16 Department of Health and Human Services Public Health Service Food
More informationIndustry Perspective on PET Manufacturing Comparison of EU and US
Standards for Imaging Endpoints and Manufacturing of PET Radiopharmaceuticals Industry Perspective on PET Manufacturing Comparison of EU and US Guidances and associated Regulations Natcher Conference Center
More informationMetrics in Microbiology Monitoring Practices
Metrics in Microbiology Monitoring Practices Crystal Booth, M.M. Masters of Microbiology from North Carolina State University Former Associate Director of Microbiology at Novartis Metrics in Microbiology
More informationTesto Expert Knowledge. The GxP Dictionary 1st edition. Definitions relating to GxP and Quality Assurance
Testo Expert Knowledge The GxP Dictionary 1st edition Definitions relating to GxP and Quality Assurance Note: Some of the information contained in this GxP Dictionary does not apply equally to all countries.
More informationEnvironmental Monitoring of Aseptic Processing Areas - 2
Environmental Monitoring of Aseptic Processing Areas - 2 A war against an invisible enemy DCVMN - Víctor Maqueda - May 30, 31, June 1 2016 1 Active Air Monitoring (Viables) Air Sieve Samplers Draw air
More informationEnvironmental Monitoring of Aseptic Processing Areas - 1
Environmental Monitoring of Aseptic Processing Areas - 1 A war against an invisible enemy DCVMN - Víctor Maqueda - May 30, 31, June 1 2016 1 Training Course Agenda Overview of Environmental Monitoring
More informationIntroduction to Medicines Inspections Technical Updates:
Introduction to Medicines Inspections Technical Updates: GMP inspections of Active Pharmaceutical Ingrédients and Finished Pharmaceutical Products (including Reproductive Health Products) Vimal Sachdeva,
More informationImpact of EU GMPs on Australian GMP. Trevor Schoerie PharmOut
Impact of EU GMPs on Australian GMP Trevor Schoerie PharmOut Part I Basic Requirements for Medicinal Products Current TGA Version, 7 years out of date TGA are actively and publically talking about PE009-0813
More informationGMP Regulations for Pharmaceutical Industry
CONTENTS Foreword... (v) Preface... (vii) CHAPTER 1 GMP Regulations for Pharmaceutical Industry 1.1 Basic Requirements of GMP... 1 1.2 Organization Pillars in cgmp... 2 a. Management Responsibilities...
More informationWebinar Expert Module 3: GMP Inspections Dupont
Webinar Expert Module 3: GMP Inspections Dupont 26 January & 9 February 2018 GOP-Innovations your Partner for Practical Training and e-learning Milenko Pavičić Pharmaceutical microbiologist, trainer, coach
More informationTrinity College Dublin QP Forum 2017 Tuesday 25 th April
Trinity College Dublin QP Forum 2017 Tuesday 25 th April HPRA QUESTIONS & ANSWERS 1. What is the approach being taken for audit of contamination control strategies as per chapters 3 & 5? What is the current
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Page 1 of 8 Inspections, Compliance, Enforcement, and Criminal Investigations Lupin Limited 5/7/09 Department of Health and Human Services Public Health Service Food and Drug Administration CENTER FOR
More informationAnnex A2. Guidance on Process Validation Scheme for Aseptically Processed Products
Annex A2 Guidance on Process Validation Scheme for Aseptically Processed Products 1 Table of content 1 PURPOSE... 3 2 SCOPE... 3 3 GENERAL INFORMATION... 3 4 INFORMATION NEEDED FOR ASEPTIC PROCESSES VALIDATION...
More informationOverview and Introduction Annex 1 Revision
Overview and Introduction Annex 1 Revision Paul Moody, Inspector Pharmig Current Hot Topics in Pharmaceutical Microbiology, Dublin May 30 th, 2018 Scope History Process of Revision Rationale for Revision
More informationGUIDE TO INSPECTIONS OF MICROBIOLOGICAL PHARMACEUTICAL QUALITY CONTROL LABORATORIES
GUIDE TO INSPECTIONS OF MICROBIOLOGICAL PHARMACEUTICAL QUALITY CONTROL LABORATORIES Note: This document is reference material for investigators and other FDA personnel. The document does not bind FDA,
More informationComplaints Investigations Root Cause Analysis
Complaints Investigations Root Cause Analysis Dr. Ademola Daramola International Relations Specialist Drugs US FDA India Office New Delhi February 22nd 2018 Information presented in this presentation does
More informationEU GMP ANNEX 1 CHANGES CLARIFICATION AND IMPACT
1 EU GMP ANNEX 1 CHANGES CLARIFICATION AND IMPACT UNDERSTAND THE PROGRESSION OF REGULATORY THINKING AND HOW TO SUCCESSFULLY IMPLEMENT THE PROPOSED CHANGES BALTIMORE, MD MAY 6TH AND 7TH, 2019 UNIVERSITY
More informationJournal of Chemical and Pharmaceutical Research
Available online www.jocpr.com Journal of Chemical and Pharmaceutical Research ISSN No: 0975-7384 CODEN(USA): JCPRC5 J. Chem. Pharm. Res., 2011, 3(6):88-98 Conduct of Inspections for Pharmaceutical Manufactures
More informationLibrary Guide: Active Pharmaceutical
Library Guide: Active Pharmaceutical Ingredients (API) Table of Contents Overview...3 Sample Curriculum...5 Course Descriptions: A Step-by-Step Approach to Process Validation (PHDV79)...7 A Tour of the
More informationTechnical updates medicines inspections: Finished Pharmaceutical Products (FPP)
Technical updates medicines inspections: Finished Pharmaceutical Products (FPP) Vimal Sachdeva, Technical Officer (Inspector) WHO Prequalification Team (PQT), WHO/HIS/EMP/RHT 20 Avenue Appia, CH - 1211,
More informationGood Manufacturing Practices Purpose and Principles of GMP. Tony Gould
Good Manufacturing Practices Purpose and Principles of GMP Tony Gould Why GMP? Provides a high level assurance that medicines are manufactured in a way that ensures their safety, efficacy and quality Medicines
More informationCDER /OPQ Office of Surveillance Quality Metrics in Surveillance
CDER /OPQ Office of Surveillance Quality Metrics in Surveillance Russell Wesdyk Acting Director Office of Surveillance Office of Surveillance Goals Builds from the shared vision A maximally efficient,
More informationHow to Select a Microbiology Contract Testing Laboratory? Tony Cundell, Ph. D. Microbiological Consulting, LLC Scarsdale, New York
How to Select a Microbiology Contract Testing Laboratory? Tony Cundell, Ph. D. Microbiological Consulting, LLC Scarsdale, New York June 13, 2017 IVT Microbiology Week 1 Presentation Overview Rationale
More informationIs it true, Annex 1 revision will have no impact on resources or cost? Walid El Azab Technical Service Manager STERIS
Is it true, Annex 1 revision will have no impact on resources or cost? Walid El Azab Technical Service Manager STERIS Agenda Annex 1 revision why? Impact of the change on the field Conclusion The Revision
More informationPrequalification of Medicines Programme
Prequalification of Medicines Programme SOP 408.4 Annex A WHO PUBLIC INSPECTION REPORT Finished Product Manufacturer WHO PUBLIC INSPECTION REPORT (WHOPIR) Finished Product Manufacturer Part 1: General
More informationSupersedes Division Name Revision No. 0 Export Division Page No. 1 of 9
Page No. 1 of 9 Control Status 1.0 Purpose To lay down a procedure for conducting GMP inspection and report writing for issue of Written Confirmation for for medicinal products for human. 2.0 Scope This
More informationEU and FDA GMP Regulations: Overview and Comparison
THE QUALITY ASSURANCE JOURNAL, VOL. 2, 55 60 (1997) EU and FDA GMP Regulations: Overview and Comparison The increasing emphasis on global supply of drug products, as well as starting materials and investigational
More informationOverview of a sterility assurance program for PET drugs
Coalition for PET Drug Approval Radiopharmaceutical Sciences Council Overview of a sterility assurance program for PET drugs Eric Webster, PETNET Solutions Disclosures Employee of PETNET Solutions, a Siemens
More informationUpdate to the Manufacturing Principles for Medicinal Products
Update to the Manufacturing Principles for Medicinal Products Michel Lok, Head of Office Robyn Oatey, GMP Auditor, Medicines Office of Manufacturing Quality Therapeutic Goods Administration Introduction
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 informationThe ABCs and Challenges of GMP The American Experience
The ABCs and Challenges of GMP The American Experience The Canadian Association of Nuclear Medicine Toronto, Ontario April 22, 2017 Reiko Oyama, R.Ph., B.C.N.P. Washington University School of Medicine
More informationAudits and Inspections
Audits and Inspections Dr. Dirk Feldmann 06. November 2017 First we take measurements, then we take measures. TECHNICAL Content Audits and inspections Types of audits EHS Challenges and chances Preparation
More informationStandard Operating Procedure Title: Initial Investigation of Out of Specification (OOS) Results in Microbiological Laboratory
Department Micro Laboratory Document no MICLAB 145 Title 1.0 DOCUMENT OWNER Laboratory/Quality Manager 2.0 PURPOSE To establish a procedure for the investigation of initial out-of-specification (OOS) or
More informationFDA s Guidance for Industry
Sterile Drug Products Produced by Aseptic Processing - CGMPs Midwest FDC Conference November 4 2005 Susan Bruederle, Investigator FDA / ORA / Central Region Chicago District / Hinsdale IL FDA s Guidance
More informationAseptic Process Validation
Aseptic Process Validation IMB GMP Information Seminar 27 th September 2012 Gerard Sheridan, Inspector Date Insert on Master Slide Slide 1 Overview Guidance Best Practices Common Deficiencies Slide 2 Aseptic
More informationPublic Health Service Food and Drug Administration Silver Spring, MD WARNING LETTER VIA UPS WL:
Department of Health and Human Services Public Health Service Food and Drug Administration Silver Spring, MD 20993 WARNING LETTER VIA UPS WL: 320-16-04 December 17, 2015 Mr. Avinash Joshi Quality Head
More informationUSP <1116> and Contamination
USP and Contamination Recovery Rates Scott Sutton ABSTRACT United States Pharmacopeia (USP) "Microbiological Control and Monitoring of Aseptic Processing Environments" approaches analysis
More informationPharmaceutical Reference Standards: Overview and Role in Global Harmonization
Matthew Borer, Ph.D., Advisor Pharmaceutical Reference Standards: Overview and Role in Global Harmonization 3rd DIA China Annual Meeting Beijing, China, 16-18 May, 2011 What is a Pharmaceutical Reference
More informationSun Pharmaceutical Industries Ltd. 12/17/15
1 of 7 02/18/2016 11:34 AM U.S. Food and Drug Administration Protecting and Promoting Your Health Sun Pharmaceutical Industries Ltd. 12/17/15 Department of Health and Human Services Public Health Service
More informationCUSTOMER AND SUPPLIER ROLES AND RESPONSIBILITIES FOR 21 CFR 11 COMPLIANCE ASSESSMENT. 21 CFR Part 11 FAQ. (Frequently Asked Questions)
21 CFR Part 11 FAQ (Frequently Asked Questions) Customer and Supplier Roles and Responsibilities for Assessment of METTLER TOLEDO STARe Software Version 16.00, including: - 21 CFR 11 Compliance software
More informationPublic Health Service Food and Drug Administration Silver Spring, MD WARNING LETTER VIA UPS WL: December 17, 2015
12/23/2015 1:37 PM 1 of 10 U.S. Food and Drug Administration Protecting and Promoting Your Health Department of Health and Human Services Public Health Service Food and Drug Administration Silver Spring,
More informationSITE MASTER FILE For MHRA
ABC CO., LTD. For MHRA Prepared by Date Approved by Date Verified by Date Document No.: SMF, Version No: 01, Effective Date: 09/05/06 Document No.: SMF Version No.: 01 Effective Date: 09/05/06 Page 2 of
More informationCompounding Pharmacies and the Contract Testing Lab
Compounding Pharmacies and the Contract Testing Lab Scott Sutton, Ph.D. scott.sutton@microbiol.org 1 Disclaimer I am making this presentation as an independent agent I am not making this presentation as
More informationGMP MANUAL Contents. Contents (1) 1 Pharmaceutical Quality System (PQS) 2 Personnel
GMP MANUAL GMP MANUAL 1 Pharmaceutical Quality System (PQS) 1.A Preface 1.B The road to a Pharmaceutical Quality System 1.C Introduction to the PQS 1.C.1 General requirements 1.C (1) 1.C.2 Documentation
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Seite 1 von 10 Inspections, Compliance, Enforcement, and Criminal Investigations Dabur Oncology PLC hhsbluebird Department of Health and Human Services Warning Letter Public Health Service Food and Drug
More informationPharmaceutical Compounding Sterile and Nonsterile Preparations. Jeanne Sun, PharmD
Pharmaceutical Compounding Sterile and Nonsterile Preparations Jeanne Sun, PharmD Agenda Legal Framework Overview Pharmaceutical Compounding Nonsterile Preparations Pharmaceutical Compounding
More informationHVAC and Risk Management RACI Meeting 7 th December Agenda. Design. Project Management. Context. Qualification. Construction
HVAC and Risk Management RACI Meeting 7 th December 2011 Dr Stephen Firmer Asia Pacific Consultants Pty Ltd Agenda Context Project Management Design Construction Qualification Routine Control /Potential
More informationfor IND and RDRC Regulated PET Compounding
Overview of USP Chapter for IND and RDRC Regulated PET Compounding Distributed Manufacturing of PET Radiopharmaceuticals for Multi-Center Clinical Trials SNM, Annual Meeting Toronto, Ontario, Canada
More informationOn behalf of the PHSS Pharmaceutical and Healthcare Sciences Society (UK).
31 st March 2015 Submission of comments on ' Concept paper on the revision of annex 1 of the guidelines on good manufacturing practice manufacture of sterile medicinal products EMA/INS/GMP/735037/2014
More informationTop Annual 483 Observations: The Cycle of Quality June 2017 Presented by: Susan Schniepp
Top Annual 483 Observations: The Cycle of Quality June 2017 Presented by: Susan Schniepp 2016 Regulatory Compliance Associates Inc. Top Observation for 5 years Year Drugs #1 citation Device #1 citation
More informationProposed Revision of USP General Chapter Radiopharmaceuticals for Positron Emission Tomography Compounding <823>
Proposed Revision of USP General Chapter Radiopharmaceuticals for Positron Emission Tomography Compounding Ravi Ravichandran, Ph.D. Steve Zigler, Ph.D. February 21, 2011 Agenda Rationale for the
More informationEU GMP ANNEX 1 DRAFT CLARIFICATION AND IMPACT
1 EU GMP ANNEX 1 DRAFT CLARIFICATION AND IMPACT UNDERSTAND THE PROGRESSION OF REGULATORY THINKING AND HOW TO SUCCESSFULLY IMPLEMENT THE PROPOSED DOCUMENTED CONTAMINATION CONTROL STRATEGY SAN FRANCISCO,
More informationGMP Requirements. Gabriel Kaddu, Senior GMP Specialist Promoting the Quality of Medicines Program (PQM) U.S. Pharmacopeial Convention (USP)
GMP Requirements Gabriel Kaddu, Senior GMP Specialist Promoting the Quality of Medicines Program (PQM) U.S. Pharmacopeial Convention (USP) 2016. ALL RIGHTS RESERVED. Outline GMP Procedures and standards
More informationInspection Trends. American Society for Quality Richmond, VA Section March 8, 2016
Inspection Trends American Society for Quality Richmond, VA Section March 8, 2016 Brooke K. Higgins, Senior Policy Advisor CDER / Office of Compliance Office of Manufacturing Quality Division of Drug Quality
More informationSIX ESSENTIAL WORKFLOW STEPS FOR PAPERLESS, AUTOMATED, END-TO-END ENVIRONMENTAL MONITORING
WHITEPAPER SIX ESSENTIAL WORKFLOW STEPS FOR PAPERLESS, AUTOMATED, END-TO-END ENVIRONMENTAL MONITORING The consequences of microbiological contamination of drug products run the gamut from FDA warning letters
More informationGMP MANUAL Contents. 1 Pharmaceutical Quality System (PQS)
GMP MANUAL GMP MANUAL 1 Pharmaceutical Quality System (PQS) 1.A Preface 1.B The road to a Pharmaceutical Quality System 1.C Introduction to the PQS 1.C.1 General requirements 1.C.2 Documentation 1.D Main
More informationCommon deficiencies/ hot topics
Common deficiencies/ hot topics Non-sterile & API manufacture Oisín Daly GMP Conference 7 February 2017 Dublin Non-sterile finished product manufacture Deficiencies by Eudralex Vol. 4 GMP guide > 60% 3
More informationEUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. This document is for consultation until 11 December 2015
Ref. Ares(2015)3808922-15/09/2015 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Medicinal Products Quality, Safety and Efficacy Brussels, [date] This document is for consultation until 11
More informationFOREIGN DRUG INSPECTION/AUDITS FROM THE FDA PERSPECTIVE
FOREIGN DRUG INSPECTION/AUDITS FROM THE FDA PERSPECTIVE Robert C. Fish EAS Consulting Group, LLC. Statistics About 80% of world supply of APIs from India and China Some API produced in Korea, but little
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 informationSterile Compounding elearning Course Curriculum 28 lessons with 33 hours of CE. Fundamentals of Sterile Compounding (8 lessons/8 hours CE)
Sterile Compounding elearning Course Curriculum 28 lessons with 33 hours of CE CriticalPoint s Sterile Compounding elearning curriculum is written by industry experts and covers both Chapter and
More informationPrequalification of Medicines Programme
Prequalification of Medicines Programme SOP 408.4 Annex A WHO PUBLIC INSPECTION REPORT Finished Product Manufacturer WHO PUBLIC INSPECTION REPORT (WHOPIR) Finished Product Manufacturer Part 1: General
More informationISPE NORDIC COP CLEAN UTILITIES SEPTEMBER TUUSULA FINLAND. Timo Kuosmanen STERIS Finn-Aqua
ISPE NORDIC COP CLEAN UTILITIES SEPTEMBER 7 2016 TUUSULA FINLAND Timo Kuosmanen STERIS Finn-Aqua Timo_Kuosmanen@steris.com AUDIT TRAIL IN CRITICAL UTILITIES MONITORING CURRENT TRENDS CONTENTS BACKGROUND
More informationAseptic Processing Current Issues & Trends
Aseptic Processing Current Issues & Trends 1 Introduction Richard M. Johnson Member, PDA for 20+ years President & CEO since 2009 Ladies and Gentlemen, I am happy to be here with you. Senhoras e Senhores,
More informationPrequalification Team Inspection services WHO PUBLIC INSPECTION REPORT (WHOPIR) Finished Product Manufacturer. Tablets
Prequalification Team Inspection services WHO PUBLIC INSPECTION REPORT (WHOPIR) Finished Product Manufacturer Part 1: information about the inspection Name of manufacturer Physical address production departments
More informationMicrobiological Consideration for Non-Sterile Pharmaceutical
May 1-3, 2012 Javits Center New York, NY Microbiological Consideration for Non-Sterile Pharmaceutical Dr. Leonard W. Mestrandrea Principal Consultant MESTRANDREA CONSULTING LLC Title Date Microbial Control
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 informationFDA s Draft Guidance Request for Quality Metrics: What All Drug and Biologics Manufacturers Need to Know June 2017
FDA s Draft Guidance Request for Quality Metrics: What All Drug and Biologics Manufacturers Need to Know June 2017 Discussion Topics Quality Concepts The Journey The Guidance Details Industry Responses
More informationGMP Track 1 Day 2 Session 1 Vendor Assurance
GMP Track 1 Day 2 Session 1 Vendor Assurance 11 August 2015 150403_POUT This session Three presentations Chapter 6 and 7 - Trevor Schoerie Quality Control Out sourced Activities Draft - FDA Quality Metrics
More informationISPE-FDA 3 rd Annual CGMP Conference 2 4 June 2014 Baltimore, MD. Detecting GMP Data Integrity Issues
Detecting GMP Data Integrity Issues Elaine Eborall Senior Director, GMP Compliance, Americas and Asia Pacific Compliance and External Collaboration ISPE-FDA cgmp Conference Baltimore, Maryland 2-4 June
More informationDraft agreed by Quality Working Party 7 June Adopted by CHMP for release for consultation 28 June 2018
1 13 November 2018 2 EMA/CHMP/CVMP/QWP/496873/2018 3 4 Committee for Medicinal Products for Human Use (CHMP) 5 Committee for Medicinal Products for Veterinary Use (CVMP) 6 7 8 Draft Draft agreed by Quality
More informationChange Control Overview
Change Control Overview Kelly Thomas Atlantic Technical and Validation Services Copyright 2014 by Atlantic Technical and Validation Services, LLC. 1 Session Outline Discuss Regulations Governing Change
More informationLessons from Pharmaceutical Laboratory related FDA Warning Letters
Lessons from Pharmaceutical Laboratory related FDA Warning Letters The Agilent Critical Compliance Seminar 2016 Ludwig Huber Ludwig_huber@labcompliance.com Overview FDA Inspections and reports GMP compliance
More informationUNICEF s Quality Assurance System for Procurement of Finished Pharmaceutical Products
UNICEF s Quality Assurance System for Procurement of Finished Pharmaceutical Products UNICEF Industry Consultation with Manufacturers and Suppliers of Finished Pharmaceutical Products 29 th 30 th September
More informationGMP for ATMPs. Ian Rees, Unit Manager Inspectorate Strategy & Innovation 4 th October 2018
GMP for ATMPs Ian Rees, Unit Manager Inspectorate Strategy & Innovation 4 th October 2018 Presentation outline MHRA Annex 2-2013 Change procedure for GMP guidelines Part IV EU & PIC/S MHRA/BP/NIBSC - standards
More informationPDA: A Global. Association. Contamination Control: Particles, Bio-contamination, Aseptic manufacturing. PDA Parenteral 2014 Munich Conference
PDA Parenteral 2014 Munich Conference PDA: A Global Contamination Control: Particles, Bio-contamination, Bioburden Association and Endotoxins in Aseptic manufacturing. James Drinkwater F Ziel Head of Aseptic
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 informationFDA Quality Metrics, Data Integrity and Application of Statistics Throughout Process Validation in a Global Economy
CBI Statistics in Validation FDA Quality Metrics, Data Integrity and Application of Statistics Throughout Process Validation in a Global Economy Jerry Lanese Ph.D. The Lanese Group, Inc. 2017 The Lanese
More informationResponding to an FDA 483
Responding to an FDA 483 Jim Melancon VP, Associate General Counsel BioScrip, Inc. Marc Stranz, PharmD Healthcare Consultant Disclosure The speakers declare no conflicts of interest or financial interest
More informationPharmaceutical cgmps for the 21st Century February 2004
Pharmaceutical cgmps for the 21st Century February 2004 Ludwig Huber Compliance Fellow for Life Sciences and Chemical Analysis Chairperson: Rob Sample FDA GxP Regulations Along the Drug Life Basic Research
More informationPhase Appropriate GMPs for IMPs. Presented by: Karen S. Ginsbury For: IFF, October 31, Nov 02, 2017
Phase Appropriate GMPs for IMPs Presented by: Karen S. Ginsbury For: IFF, October 31, Nov 02, 2017 1 Lets start with References https://mhrainspectorate.blog.gov.uk/2016/0 5/20/manufacture-of-investigationalmedicinal-products-frequently-askedquestions/
More informationMicrobiological Cleaning Method Validation
Microbiological Cleaning Method Validation The purpose of cleaning procedures should never be to reduce bioburden to an acceptable level! Fergus O Connell QA Manager Eurofins ams Laboratories www.eurofins.com
More informationHealth Authority Inspection Management. GMP Inspection practices L. Mansolelli, Group Compliance & Auditing June 2012
Health Authority Inspection Management GMP Inspection practices L. Mansolelli, Group Compliance & Auditing June 2012 Abstract As global health authorities align in inspection standards and practices, key
More informationIntroduction and Background
Introduction and Background Validation of Biotech Facilities Pacific Biotech Alliance Robert J. Mackey Pacific Biotech Alliance is an established consulting firm in the Pacific Northwest that specializes
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 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 informationU.S. EU Harmonization
U.S. EU Harmonization by Pepe Rodriguez-Perez, PhD Business Excellence Consulting Inc BEC SPAIN SL www.calidadpr.com www.bec-global.com info@calidadpr.com info@bec-global.com Agenda Mutual Recognition
More informationQuality Assessment & GMP Similarities & Differences
Quality Assessment & GMP Similarities & Differences EMEA, Monday 26 th October 2009 Cormac Dalton Inspector Irish Medicines Board Date 12-Oct-09 Slide 1 Content Overview of commonalities & differences
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 information