1 Overview of Pre-Approval Inspections Presented by: Kelli F. Dobilas NWJ-DO Pre-Approval Manager
2 Pre-Approval Drug Inspections
3 What are Pre-Approval Inspections? One of the last reviews of the drug approval process, which may effect the availability to the consumer.
4 Compliance Program Objective- Assure that establishments involved in the manufacturing, testing, or other manipulation of new drug dosage forms and new drug substances are audited. (pg. 5 of CP)
5 Compliance Program Audited for: 1) compliance with CGMPs 2) for conformance with application commitments 3) authentic and accurate data 4) laboratory testing of products, including evaluations of the adequacy of analytical methodology
6 Other Compliance Programs Drug Manufacturing Inspections- as most of the time PAI will also incorporate GMP coverage of facility Center for Veterinary Medicine- CVM
7 History of Pre-Approval Inspections Generic Drug Scandal of 1980 s l990, when the agency instituted productspecific, pre-approval inspections of manufacturing sites listed in a sponsor's application.
8 Pre-Approval Acronyms PAM- Pre-Approval Manager PAI- Pre-Approval Inspection NDA- New Drug Application ANDA- Abbreviated New Drug Application IND- Investigational New Drug NADA- New Animal Drug Application (Issued through Centers Veterinary Medicine or CVM).
9 Pre-Approval Acronyms PDUFA- Prescription Drug User Fee Act User Fee Date- The date by which an agency decision on an application is due Why is this so important to the Agency?
10 PDUFA Prescription Drug User Fee Act of 1992 Allows FDA to charge for reviewing applications- in return, FDA commits to taking quicker actions in applications Provides FDA with increasing levels of resources
11 PDUFA II As a result of success, PDUFA was reauthorized extended through September 20, 2002 By 2002, PDUFA fees permitted FDA to spend an additional $161.8 million/year for the drug evaluation process Resources spent to hire personnel to review applications; update IT infrastructure
12 PDUFA Congress re-evaluates and considers renewal of PDUFA every 5 years
13 Pre-Approval Acronyms CMC- Chemistry, Manufacturing, and Controls (reviewed by investigator during inspection) Contained within CMC sections information about API; excipients; manufacturing process; reprocessing; analytical/micro testing; packaging/labeling; components; stability
14 Pre-Approval Acronyms Bioequivalence Study- A Bioavailability Study in which a comparison is made between two or more products. A generic drug (filed under an ANDA) must prove bioequivalence to the brand drug (NDA) for which it is compared. Comparison must be noted in application.
15 Generics are not required to replicate the extensive clinical trials that have already been used in the development of the original, brand-name drug. Instead, they must show they are bioequivalent to the pioneer/innovator drug and fall into acceptable parameters set for bioavailability, which is the extent and the rate at which the body absorbs the drug.
16 Pre-Approval Acronyms Biobatch for generic product (ANDA) - The batch of dosage form in which the bioequivalency study was conducted to demonstrate equivalence to the innovator product (NDA).
17 Pre-Approval Acronyms Biobatch for brand product (NDA)- the batch tested in the clinic in which the pivotal studies were conducted or the batch used in a bioequivalency study that was compared against the pivotal clinical batch.
18 Role of the PAI Manager
19 Role of the PAI Manager Liaison between Centers, Field & Applicants Physically manages 3 rd copy CMC & Correspondence Review of 3 rd copy to highlight inspectional concerns Issues PAI Inspections to District for assignment to CSOs
20 Role of the PAI Manager Receives Assignments from CDER/CVM Reviews firm s GMP history Contacts firm for clarification on operations related to application/general GMP Responds to Centers Responds to firms Schedules Post-Approval Inspections, if necessary (under CP )
21 Role of the PAI Manager Is the application for a new chemical entity? Is the application for the first generic drug? Was a GMP inspection conducted within the last year? Does the firm have an acceptable status?
22 Role of the PAI Manager What do we inspect? NDA s, ANDA s, NADA s & IND s which are manufactured, tested or packaged at either a Domestic or International Facility Inspectional coverage will include supplements (prior approval, CBE and SUPAC) All establishments listed within an application may be inspected
23 Role of the PAI Manager EES- Establishment Evaluation System- Computer system used for tracking the status of drug applications; assignments and associated firms; accessible only by the Pre-Approval Manager. (PDUFA dates and special comments for applications are noted within EES system).
24 Role of the PAI Manager Receives all third copies of applications. Issues pre-approval assignments. Tracks all district pre-approval activities. Enters District recommendations/information into EES.; Reviews inspection information (483, EIRs) for PAI, NAI- VAI inspections. Reviews inspection information (483, EIRs,) with Compliance Officer for OAI inspections which included PAI coverage. Communicates application status information to the inspected firms (District Status Notification letters).
25 Role of Firm-(manufacturing establishment)
26 Role of Firm-(manufacturing establishment Make records available to conduct the preapproval inspection Development Report Batch Records Laboratory Records Protocols/SOPs
27 Role of Firm-(manufacturing establishment The manufacturing and all associated facilities must be listed within the application (contract labs, packagers, etc.). Once an application is submitted to Center, firm and all facilities should be considered ready for inspection.
28 FDA Investigator s Role
29 FDA Investigator s Role Evaluate overall cgmp compliance Evaluate specific product and process - Is the facility adequate-building; equipment; water systems? - Is there data to justify the process? - Is there evidence/data to support the manufacturing process? - Review R&D information - Product Development Report
30 Product Development Report The data generated during product development which defines the drug product and targets the steps in the manufacturing process where variation is critical to quality and thereby focus the subsequent process validation effort.
31 Product Development Report API - Impurity Profile How is API characterized Excipients Formulation: Wet or Dry Granulation Solution or Suspension Sterile - Terminal/aseptic conditions Tablet/Capsule - Immediate/Modified Release/Extended Release
32 Product Development Report Processing: Equipment, order of addition of ingredients to the formulation, mixing times and speeds, drying time and temperature, nitrogen blankets, blending, hold times, compression, slugging, filling, polishing, imprinting, labeling and packaging. Product Report may not be a formal document
33 FDA Investigator s Role Development Data-look at all R&D batches Impurity Profile- note specifications Specifications (Data to support) Production Trends Change Control FDA Correspondence/ Deficiency Letters Stability Data
34 Equipment Qualification During the inspection the following areas should be covered: Installation Qualification Operational Qualification Performance Qualification
35 FDA Investigator s Role Sampling Plan-(SOPs outlining; techniques training of personnel) Laboratory-(SOPs; Personnel; Training) Test Methods-(Validated) Target Drug Product Specifications Reprocessing/Reworking Standard Operating Procedures Batch Records-submission batches
36 FDA Investigator s Role Reprocessing/Reworking- GMP regulations require reprocessing procedures to be in writing. If firm makes provisions for reprocessing drug product, details must be submitted as part of the application. Standard Operating Procedures Review all Batch Records-submission batches ;master batch records
37 Batch Records The batch records submitted in the application must be audited as part of the inspection to assure: That the proposed production process is the same process that was used for the manufacture of the bio/stability batches.
38 In summary the FDA Investigator s Role Conduct assigned pre-approval inspections in accordance with the compliance program and DO SOP. Conduct the pre-approval inspections by the due date listed in the assignment (or communicates the delay to the Pre-Approval Manager). Notifies Pre-Approval Manager with an Approve or Withhold recommendation. Collects profile samples per compliance program ; District policy/iom; and Profile Sample Memo issued in Completes all PDUFA assignments and gives recommendation by due date (no exceptions!!!).
39 In summary the FDA Investigator s Role Investigator should inform firm of the outcome of the inspection. Inspected firm will receive a Post Inspectional Letter from the inspecting district informing them of recommendation made to CDER. Firm should receive a copy of the establishment inspection report (FMD-145)
40 Examples of 483 Observations Analysts had access to all data which was stored on the hard drive. With no security measures taken, including no procedures for backup, no procedures for password usage, and no procedures for data file handling, analysts could overwrite, alter and delete original data.
41 Examples of 483 Observations Segregation of particles in a new hopper over the encapsulation operation resulted in a failure of the validation bulk capsule assay criteria. Validation personnel failed to notify Quality Assurance of the failure. The product was recalled from the market on.
42 Examples of 483 Observations Other examples have been related to: No raw data or missing data to support he application No investigation of batch failures or out-ofspecification (OOS) results Lack of validation for essential equipment Lack of validated analytical methods
43 Communicate Communicate findings with firm Discuss your recommendation with your supervisor; with PAM Within 2 days send recommendation to PAM (CDER EES Report- page 2)
44 NWJ-DO- Past examples for reasons to Withhold Ill defined API quality-particle size, potency failure, quality attributes No processing equipment qualification Inadequate manufacturing environment Manufacturing and Laboratory OOS and Deviation Investigations Ill defined processing procedures Laboratory Data & Results Reporting
45 40 Withhold Recommendation Categories Drug not made here Facility withdrawn from application Firm not ready Inadequate firm response Previous deviations persist
46 40 Withhold Recommendation Categories Insufficient development data Building & Facilities Contamination Pending regulatory actions Warning Letter Seizure Injunction
47 40 Withhold Recommendation Categories Inadequate change control procedure Component or intermediate controls Deviation from DMF/NDA/ANDA Deviation from monograph Environmental controls
48 40 Withhold Recommendation Categories Holding & distribution Lab controls Master record non-specific or deficient Packaging and labeling controls Production and process controls QA Functions
49 40 Withhold Recommendation Categories Organization Records/reports Reprocessing Specifications Stability program SOP s lacking or inadequate Training System Qualification (IQ/OQ)
50 40 Withhold Recommendation Categories Validation Issues API process validation computer validation HVAC validation Media Fills Water system validation Scale-up validation failure Validation protocol inadequate Equipment Qualification Equipment cleaning validation
Compliance, FDA Inspection and Product Quality Jim Li, Ph.D. MBA Presentation Overview Regulations and Guidance: DP: 21 CFR Parts 210 & 211 DS: ICH Q7A System based approach FDA expectation in GMP compliance
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
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
Generic Drug Review Hanan Kakish Medical Research Scientist, M.Sc. Pharm. Middle East and North Africa Post Office of International Programs U.S. Food and Drug Administration Hanan.firstname.lastname@example.org Kakishh@state.gov
Changes to an Approved Product Chemistry, Manufacturing and Controls By Khandan Baradaran, PhD and Peggy Berry, MBA, RAC It is a huge achievement for any company to obtain licensing rights to an approved
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
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
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
CHAPTER-II ABBREVIATED NEW DRUG APPLICATION (ANDA) by: j. jayasutha lecturer department of pharmacy practice Srm college of pharmacy srm university ABBREVIATED NEW DRUG APPLICATION INTRODUCTION ANDA is
Development & The US FDA Approval of Generic Drugs May 18, 2011 Beijing, China SHAO Jun, Ph.D. Agenda About Generic Drugs Business Strategy for Generic Drugs Generic Drug Product Development Generic Drug
SKILLS/SPECIAL QUALIFICATIONS: Regulatory Expertise: Technical Expertise: CAPT. (RET) TERRI L. DODDS - BSN, RN Former Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals,
CMC Workshop From Drug Development to Global Supply to Patients April 15-17, 2013, Washington, DC Post-Approval Change Management: Challenges and Opportunities An FDA Perspective Christine M. V. Moore,
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.
PRODUCT DEVELOPMENT GUIDE PRE-FORMULATION - TABLETS Introduction Guidelines for the development of a ANDA product for the US market, Note: some tests or procedures may be unnecessary. The order of performing
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
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
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
Best Practices In Ensuring Quality Standards When Outsourcing To Contract Manufacturers, Licensees And Consultants Alex D. Kanarek, PhD BioProcess Technology Consultants, Inc. Strategic Institute Quality
PRODUCT DEVELOPMENT GUIDE CONTROLLED RELEASE DOSAGE FORMS PRE-FORMULATION Introduction Guidelines for the development of a controlled release product primary for the US market, Note: some tests or procedures
FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL PROGRAM 7356.002F CHAPTER 56 DRUG QUALITY ASSURANCE SUBJECT: ACTIVE PHARMACEUTICAL INGREDIENT (API) PROCESS INSPECTION Revision Note: Program
Guidance for Industry Contract Manufacturing Arrangements for Drugs: Quality Agreements DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding
CGMP for Phase 1 Clinical Trials Harvey M. Arbit, PharmD, MBA, RAC, CCRP University of Minnesota Academic Health Center Director, IND/IDE Assistance Program Lead, Regulatory Knowledge and Support Clinical
October 11, 2013 Division of Dockets Management (HFA-305) Food and Drug Administration Department of Health and Human Services 5630 Fishers Lane Room 1061 Rockville, MD 20852 Comments of the Generic Pharmaceutical
Common Process Related Deficiencies Sharmista Chatterjee, Ph.D. Division Director (Acting) Division of Process Assessment II Office of Process & Facilities (OPF)/OPQ/CDER/FDA 2016 GPhA CMC Workshop May
Pharmaceutical Quality Systems: US Perspective Rick Friedman Associate Director, Office of Manufacturing and Product Quality Center for Drug Evaluation and Research Topics Background: The ICH Q10 Pharmaceutical
Combination Products Presented by: Karen S. Ginsbury For: IFF March 2014 Types of products Biological and medical device (freeze dried + syringe dual volume) Medical device and plasma devised product (syringe)
Analytical Method Validation in Early Drug Development US FDA Perspective Linda Ng, Ph.D. Office of Manufacturing & Product Quality, Office of Compliance Best Practices and Application of GMPs for Small
Synopsis: FDA Process Validation Guidance This synopsis is a comparison of the draft version 2008 and the final version 2011 of the U.S. FDA Guidance Process Validation: General Principles and Practices.
The Quality System for Drugs in Germany Prof. Dr. Harald G. Schweim Head of Department for Drug Regulatory Affairs Institute for Pharmacy, University of Bonn Former President of the German Federal Institute
T ECHNICAL G UIDE EXPANDING THE GLOBAL KNOWLEDGE BASE FOR COMPLIANCE PROFESSIONALS IN FDA-REGULATED INDUSTRIES. Technical Guide 1 A Practical Guide to Change Control Systems Management... FDA has cited
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,
Content and Format of Chemistry, Manufacturing, and Controls (CMC) in a New Drug Application (NDA) - -PET Drug Products- Ravindra K Kasliwal, Ph.D. Office of New Drug Quality Assessment Center for Drug
NEW CHEMICAL ENTITIES PIONEERING PARTNER FOR PEPTIDES With more than 40 years of expertise in peptide synthesis, a track record in process development, large-scale manufacturing and outstanding product
Guidance for Industry Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications Comments and suggestions regarding this document should be submitted within 90 days of publication in the
Guidance for Industry Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation
Extemporaneously Prepared Early Phase Clinical Trial Materials Richard Hoffman, MS, RAC Eli Lilly & Co. Regulatory Advisor International Consortium for Innovation & Quality in Pharmaceutical Development
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
Risk Based Pre-Approval Inspection PQRI-FDA Conference on Advancing Product Quality October 5, 2015 Christine Moore, Ph.D. Acting Director, Office of Process and Facilities FDA/CDER/OPQ Outline Background
International GMP Requirements for Quality Control Laboratories and Recomendations for Implementation Ludwig Huber, Ph.D. email@example.com Overview GMP requirements for Quality Control laboratories
Panel Discussion: Generic Drug User Fee ACT (GDUFA) April 23, 2013 GDUFA: From the FDA s Website: (www.fda.gov/forindustry/userfees/genericdruguserfees/default.htm, accessed 4/16/13) The Generic Drug User
5 Guidance for Industry Drug Stability Guidelines (This version of the guidance replaces the version that was made available in December 1990. This guidance document has been revised to correct the contact
Coalition for PET Drug Approval Radiopharmaceutical Sciences Council Reporting Changes to an Approved NDA or ANDA SNMMI Annual Meeting - June 8, 2015 Michael Nazerias Sr. Director RA/QA PETNET Solutions,
Overview of Drug Development: the Regulatory Process Roger D. Nolan, PhD Director, Project Operations Calvert Research Institute November, 2006 Adapted from course taught by Cato Research Background: Roger
Question-based Review for ANDAs Chi-wan Chen, Ph.D. Executive Director, Pfizer Member, FDA Alumni Association DIA China, Beijing, China May 15-18, 2011 Disclosures I am currently an employee of Pfizer,
SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT Guideline Title Specifications and Control Tests on the Finished Product Legislative basis Directive 75/318/EEC as amended Date of first adoption
HOW TO DEAL IN A REGULATED ENVIRONMENT Matt Rigerman Director Operations & Quality Reichert, Inc. CMQ/OE, CSSBB, CQA AGENDA Origin of the FDA Medical Devices standard (21 CFR 820) Compliance strengthens
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Public Health and Risk Assessment Pharmaceuticals Brussels, SANCO/C8/AM/sl/ares(2010)1064587 EudraLex The Rules Governing Medicinal Products
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
Pre-Approval Process INAD vs. NADA Barbara M. Leotta, DVM CVM/ONADE/DTDNFA (240)276-8262 firstname.lastname@example.org Pre-Approval Process General Overview Pathways To Legal Marketing Office of New Animal
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
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
Veterinary Compounding Veterinarians occasionally use compounded preparations to meet a specific patient s medical need. The purpose of this brochure, created jointly by the Animal Health Institute (AHI),
SUBJECT: COMPRESSED MEDICAL GASES Cross-reference: 7356.002 (version 02/01/2002) IMPLEMENTATION DATE March 15, 2015 COMPLETION DATE March 15, 2018 DATA REPORTING PRODUCT CODES Medical Gases Industry codes:
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
Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors FDA Institutional Review Board Inspections Additional copies are available from: Office of Good Clinical Practice Office of Special
FOOD AND DRUG LAW JOURNAL Analyzing the Laws, Regulations, and Policies Affecting FDA-Regulated Products Enforcement Protecting the Public s Health Through the Application Integrity Policy Paula R. Katz
Paul L. Pluta and Richard Poska] Process Understanding Manufacturing Processes EXECUTIVE SUMMARY Recent regulatory documents and discussions have emphasized a more comprehensive and integrated approach
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
GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group email@example.com Common Misconception Good Laboratory Practices 1) A quality system concerned with the organizational process
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
Guidance for Industry ANDA Submissions Amendments and Easily Correctable Deficiencies Under GDUFA DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions
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
This article illustrates the risk analysis guidance discussed in GAMP 4. 5 By applying GAMP s risk analysis method to three generic classes of software systems, this article acts as both an introduction
Quality Management System (QMS) for Active Pharmaceutical Ingredients (API) Manufacturers integrating GMP (ICH Q7a) into ISO (9001: 2000) September 2005 Quality Management System - integrating GMP (ICH
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
Guidance for Industry Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products Center for
Questionnaire for preparing GMP-inspections Questionnaire for preparing GMP-inspections Dr. Christine Oechslein, Max Lazar, Thomas Halfmann Here you will find answers to the following questions: What questions
Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles 1 Introduction 79 General considerations 80 Glossary 81 Quality management in the medicines industry: philosophy and
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
Generic Drug Development: Preparing Abbreviated New Drug Applications For Submission Fall Technical Conference Generic Pharmaceutical Association November 4, 2015 Larissa Lapteva, M.D., M.H.S. Division
Thomas Hinchliffe, Pharm.D. CDR, U.S. Public Health Service Special Assistant to the Director Office of Generic Drugs Food and Drug Administration Disclaimer & Disclosure Views presented are those of the
PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 010-4 3 Appendices 1 January 2011 STANDARD OPERATING PROCEDURE PROCEDURE FOR HANDLING RAPID ALERTS AND RECALLS ARISING
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
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
Comparative analysis between the possible regulatory approaches to GMP compliance TITOLO PRESENTAZIONE Dr. Fulvio CARLOTTI, GNOSIS SpA, Corporate QA Director September 26, 2014 Scope of GMP GMP compliance
The US-FDA pending Generic Drug User Fees Act (GDUFA) is expected to come into force on 1 st October, 2012. A slide set was provided to participants as a comprehensive brief to stimulate questions. Those
Conducting a Gap Analysis on your Change Control System Presented By Miguel Montalvo, President, Expert Validation Consulting, Inc. Standards, Regulations, Guidelines related to Change Control Management
USP Pharmaceutical Ingredient Supplier Qualification Program Manual for Participants UNITED STATES PHARMACOPEIA Drug Substance Supplier Qualification Program ICE This manual provides information to drug
Preparing for an FDA Pre-Approval Inspection (PAI) Jorge Torres CMQ/OE, CQE, CQA July, 2007 1 Agenda Introduction Understanding the PAI Experience: What to Expect Inspection Management Plan Preparing for
Current Good Manufacturing Practices, and FDA Enforcement Actions and Inspections John R. Fleder, Esq. Holly S. Tucker Hyman, Phelps & McNamara, P.C. firstname.lastname@example.org email@example.com www.hpm.com FDA GMP Repackaging
Importing pharmaceutical products to China Imported pharmaceutical products need pre-market approval before entering the Chinese market Imported drugs for human use are required to obtain pre-market approval
UNICEF s Quality Assurance System for procurement of medicines QA Specialist Peter Svarrer Jakobsen Joint UNICEF, UNFPA and WHO Meeting with Manufacturers and Suppliers UN City, Copenhagen 23 September
Career Opportunities at FDA From a regulatory scientist perspective Ke Zhang, Ph.D. U.S. Food and Drug Administration Silver Spring, MD Disclaimers 1. The views expressed in this presentation are those
CATEGORY Advertising Guidance Agenda: New & Guidances CDER is Planning to Publish During Calendar Year 2016 (See the Good Guidance Practices (GGPs) regulation on this Web page or 21 CFR 10.115 for details
FDA Inspections: an investigator s perspective Lori S. Lawless Medical Device Specialist Supervisory Consumer Safety Officer Food & Drug Administration Baltimore District Lori.Lawless@fda.hhs.gov (410)