Performing Multiple Regulatory Requirements within a Program Such as GMP, GLP, GCP, Medical Devices, and/or Controlled Substances

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1 Performing Multiple Regulatory Requirements within a Program Such as GMP, GLP, GCP, Medical Devices, and/or Controlled Substances

Performing Multiple Regulatory Requirements within a Program Such as GMP, GLP, GCP, Medical Devices, and/or Controlled Substances Pharma work may require multiple GXP programs GMP GLP DEA Medical

2 Performing Multiple Regulatory Requirements within a Program Such as GMP, GLP, GCP, Medical Devices, and/or Controlled Substances Pharma work may require multiple GXP programs GMP GLP DEA Medical Device GCP These may include special training practices, documentation efforts, facility and equipment processes, interactions from one regulation to another as well as the monitoring of record keeping and reporting. Attempting to run multiple programs may fail if: Duplicate procedures are provided with conflicting requirements

3 Overview Establishing a Quality Management System The Umbrella of the QMS Reinforcement of Top Management Continued Support Developing a Quality Team of All Stakeholders Providing feedback to groups

4 Quality Management System Defines the Organization Establishes Leadership and Management Senior management acting as role models for how all employees should work

5 Quality Management System Team Project Team Quality Assurance Management

Certified Quality System A quality management system (QMS) is essential in today s market Strong marketing tool Limits competition due to cost and

6 Certified Quality System A quality management system (QMS) is essential in today s market Strong marketing tool Limits competition due to cost and required infrastructure Provides clients with assurances that systems are under control Focuses staff on improvement, compliance, and customer satisfaction

7 Integration of Multiple QMSs under ISO 9001 DEA ISO GLP 58, 160 USDA GMP 211 AR 50 6 ISO 9001 NQA1 DOE/ DOD NELAC (EPA)

9 Good Manufacturing Practice (cgmp) 21 CFR Part 11 Compliance for Software 21 CFR Part 210 Current GMP in Manufacturing, Processing, Packing, or Holding of Drugs; General; 21 CFR Part 211 Current GMP Practice in Finished Pharmaceuticals 9

approach Announced Aug 2016 EPA FIFRA (Federal Insecticide, Fungicide & Rodent

10 Good Laboratory Practice (GLP) FDA (Food & Drug Administration; 40 CFR Part 58) FDA is proposing to amend regulations to require a complete quality system approach Announced Aug 2016 EPA FIFRA (Federal Insecticide, Fungicide & Rodent Act; 40 CFR Part 160) EPA TSCA (Toxic Substance Control Act; 40 CFR Part 792) 10

11 Medical Devices ISO 13485:2003 Medical Devices Quality Management Quality Requirement Manual (QRM) Revision 2 Project Quality Plans 21 CFR Part 820 Food And Drug Administration Department Of Health And Human Services Subchapter H Medical Devices 11

12 ISO 9001:2015 Quality System Controlled notebooks Controlled procedures Quality Records Archived Division 01 Traceability Software and Hardware controls Design control Quality Project Plan Training Corrective Actions (QRS) Internal Audits

13 Drug Enforcement Agency (DEA) (Department of Justice) All projects involving controlled substances requires a DEA license for either manufacturing or research Licenses maintained by the Legal Department

14 DEA (Drug Enforcement Agency) Pharmaceutical programs may involve controlled substances requiring Traceability Audit trail Special Reporting Secure & Limited Access to drug Accountability DEA registration

15 DEA Research/Manufacturing Research Traceability Zero tolerance Locked cabinet Limited access Signed DEA access ISO Requirements DEAAudit Potential Surveillance to control DEA Training Biennial Inventory Manufacturing Traceability Zero tolerance Regulation Safe Limited access Signed DEA access ISO Requirements DEA Audit Definite ARCOS Requirements DEA Training Biennial Inventory EOY Inventory

16 Integration of Multiple QMSs under ISO 9001 ISO DEA GLP 58, 160 ISO 9001 USDA GMP 211 NELAC (EPA)

17 The ISO Umbrella The ISO 9001 is the umbrella that allows the organization to meet other regulatory requirements. Procedures required by other program are already identified in the ISO 9001 SOPs

18 ISO 9001:2015 Minimums The ISO Procedures on all Projects for all Division 01 Staff Document Control Forms, TAPs, Plans, Notebooks Data Control and Reporting A minimum for all reports to paying clients Training Some regulatory groups have zero tolerance for delinquent training i.e. FDA Calibration Of any measurement activity Evaluate Risks Approved Supplier List For all class 1 items At the manufacturing facility not the distributor Nonconforming processes, procedures If we do not document the problem and corrective action the auditor/client will define as a finding

20 ISO 9001 Establishes criteria for a quality management system Used across all industries, organizations and countries Based on a number of quality principles Customer focus Leadership Engagement of people Process approach Improvement Evidenced-based decision making Relationship management

Organization/ Personnel Facilities Equipment Risk Document Control Purchasing CAPA Records and Reports ISO 9001 cgmp 21 CFR Part 211 GLP 21 CFR Part 58 40 CFR Part 160 GCP 21 CFR Part 312 Medical

21 Organization/ Personnel Facilities Equipment Risk Document Control Purchasing CAPA Records and Reports ISO 9001 cgmp 21 CFR Part 211 GLP 21 CFR Part CFR Part 160 GCP 21 CFR Part 312 Medical Device ISO CFR Part 820 DEA 21 CFR Part 1300 QA for GMP GMP Recalls OOS Validation Qualification BSE/TSE Stability Study Dev. Study Director Protocol Final Report QAU Master Schedule Clinical Study CRO Randomization Monitor Human Subject IRB Bioavailability Device Record Design Review Design Transfer Cert. Mark Investigation Informed Consent Form 222 Inventory Use & Tracking ACROS EOY Inventory Quota

22 Develop The Quality Team (Quality Circle)

Quality Management System Document Control Organization and Responsibility Evaluation of Risk Opportunities Computer Hardware/Software Management Review Qualification and Training Laboratory

23 Quality Management System Document Control Organization and Responsibility Evaluation of Risk Opportunities Computer Hardware/Software Management Review Qualification and Training Laboratory Notebooks Requirements Data Control and Reporting Storage and Maintenance of Quality Records Control of Measuring and Test Equipment Monitoring and Measurement Preparation/Review/Approval of Proposals and Contracts Purchasing Control of Customer Supplied Items Handling, Storage, Packaging Protection, and Delivery of Items Customer Feedback/Complaints Internal/External Quality Audits Nonconforming Material Quality System Trending CAPA Program

24 Risk Evaluation Required in 9001, GMP, Medical Device, DEA, but beneficial in other regs

Once the key SOPs are developed the required procedures may apply to

time. Avoids the need for multiple revisions Most programs require 70

other requirements Provide the main SOPs as a controlled document for

25 Once the key SOPs are developed the required procedures may apply to multiple programs One time documents When revised, the revision is one time. Avoids the need for multiple revisions Most programs require 70 to 90% of the SOPs identified Titles of the main SOP are general to other requirements Provide the main SOPs as a controlled document for all Audits Sub SOPs as needed may be added to the QMS to avoid duplicate procedures

26 MANAGEMENT REVIEW Management review allows the QMS for Trending and Reporting Identify a Quality Program within your CAPA System This allows each program to be trended by defect code Minimizes efforts of multiple programs for management review

27 Document/Change Control Involves initial request for all documents Revisions needed during review Notebooks Protocols Plan Form Change Control (GMP/Medical Device/GCP) Reason for Change Documents affected QA Approval prior to change Follow up and Close out of Change

Approvals Initial and continual training Quality Assurances Plans for projects

31 Quality is not Free!! Creation of initial processes Preparing Standard Operating Procedures Review and Approvals Initial and continual training Quality Assurances Plans for projects Documentation Calibration and documentation of compliance Demonstration of competency 25 to 45 external client or regulatory audits per year Archiving results and studies

32 Benefits of Quality? Each audit has the umbrella procedures for ease Added Program procedures are effective Continual Improvements due to the additional audits Repetitiveness throughout all programs Efficient Systems Compliance Continuous training repetitiveness Customer retention New Customers Growth for different programs

Leadership and Management Most programs require Management

programs going through revisions Top Management shall

34 Leadership and Management Most programs require Management as leaders and continual support of the program All ISO programs going through revisions Top Management shall demonstrate leadership and commitment by. GLP Testing facility management shall.. Medical Device Executive responsibility shall ensure. DEA Reports to highest level of management..

35 LEADS PROJECTS TOP MANAGEMENT COMMITMENT TO QUALITY AND INTEGRITY CULTURE AND FINANCE ACCOUNTABLE LEADERSHIP AND MANAGMENT DECISION AND PROBLEM SOLVERS PERFORMANCE AND INTEGRITY MANAGEMENT

How to Initiate a New QMS to current programs Establish the QMS elements and procedures Develop SOPs and review for the QMS elements Train to the new QMS SOPs and explain the tiered effects

36 How to Initiate a New QMS to current programs Establish the QMS elements and procedures Develop SOPs and review for the QMS elements Train to the new QMS SOPs and explain the tiered effects Incorporate the new QMS by merging the existing programs: Review each program SOP and delete duplicate SOPs to the new SOP Check remaining program SOPs for reference to those duplicates and reference new SOP replacing the duplicate Program Quality Program Plans are helpful to reference all documents associated Train to the completed programs Reinforce the new references in existing documents

Adding a New Program to the QMS Consider a Quality Program Plan (QPP) The plan identifies the minimal program elements The QPP will identify current SOPs developed in the umbrella QMS Establish

37 Adding a New Program to the QMS Consider a Quality Program Plan (QPP) The plan identifies the minimal program elements The QPP will identify current SOPs developed in the umbrella QMS Establish additional elements required for the new program Review the QPP to reference the new SOPs for the new program Train staff involved in the new program to QPP and emphasize reference documents New documents for the new program Utilize this process for program auditors

38 JoAnn Boyd, MBA Quality Assurance Manager Southwest Research Institute (210)

GxP Auditing, Remediation, and Quality System Resourcing

GxP Auditing, Remediation, and Quality System Resourcing TABLE OF CONTENTS 3 Introduction 4 GxP Auditing 4 GMP Auditing 5 GCP Auditing 6 GLP Auditing 7 Pharmacovigilance Auditing 7 Vendor/Supplier Auditing