Strategies to Revise Quality Policy and Quality Objectives. Eileen Cortes February 22, 2017

Transcription

1 Strategies to Revise Quality Policy and Quality Objectives Eileen Cortes February 22, 2017

2 Agenda Elements of Compliance Quality Policy Outline Quality Strategy and Objectives Case Study Open Discussion

3 Elements of Compliance

4 Identification of Elements of Compliance Quality and Compliance are key factors of any manufacturing process and product; but What is the difference between them? What is Quality? Quality is defined as products and services that deliver intended performance Results against Specifications In Summary Management, Resources, Products, and Measurement systems are in alignment for a specific outcome What is Compliance? Compliance is defined as meeting regulatory requirements (conforming to a rule, policy or law) Product Safety Data Integrity Controls In summary Meeting cgmp s

5 Identification of Elements of Compliance Quality and Compliance are Different but Compliment each other Quality Quantitative Compliance Qualitative

6 Identification of Elements of Compliance Main Elements of Compliance Validation Quality Systems Analytical Laboratory Quality Engineering Supply Chain CMO s and Third Parties

7 Identification of Elements of Compliance WHAT??? Compliance Program Review Policies and Procedures against Regulations to prevent and detect (in time) violations of the Regulations Compliance Program must Focus on: HOW??? Ethical Behavior Right Values Culture of Integrity By Implementing QUALITY

8 Quality Policy

9 Quality Policies Regulations require QUALITY POLICIES to ensure that Executive Management has established a System for Quality What are Quality Policies? Quality Policies are the Commitment to QUALITY and COMPLIANCE How we Manage the Commitment Quality Plan Quality Review Quality Manual Quality Metrics Quality Risk Management

10 Quality Policies Purpose To describe the process and responsibilities that the Executive Management must support and endorse Scope Shall cover all cgmp Operations (internal and external), contract testing and distribution Responsibilities Executive Management Responsibility must be defined VP Quality VP Operations VP R&D CEO COO

11 Quality Policies Procedure Define activities of the following main areas: Compliance i.e. Management of Regulatory Inspections, Status of Commitments, Regulatory Trends, Upcoming Regulations that may impact GMP processes Product Quality i.e. Management of Annual Product Reviews, Complaints, Regulatory Actions Internal Compliance i.e. Management of Internal Audit Results, Quality Risk Assessments Quality Performance i.e. Management of Quality Management Review and Quality Metrics for Manufacturing, Quality Control Continuous Improvement i.e. Management/Review of Effectiveness Checks, CAPA and Change Controls

12 Quality Strategies

13 Quality Plan Quality Plan Goals To enhance the efficiency and effectiveness of the Quality Management System by assuring that it is defined, integrated, and measured To enhance understanding of products and process performance as the basis for continuous quality improvement To enable the use of Quality Risk Management principles in process and product understanding and decision making To improve the Supplier Management Program To enable the use of Knowledge Management principles in enhancing decision making and product and process understanding To enhance the organization Quality Culture, staff development, and working environment.

14 Quality Manual Quality Manual Purpose Describes the scope, roles, responsibilities and organization of the Quality Unit, as well as the elements and subsystems of the Quality Management system Quality Management System Consists of 6 main elements: QMS Documents Resource Management Audits Corrective and Preventive Actions (CAPA) Change Controls Quality Management Review

15 Quality Manual QMS Documents Identification of Standard Operating Procedures and Quality Records Describe Documents Hierarchy Policies Standards Global SOPs Site SOPs Work Instructions and Forms Describe how Quality Records are Managed and Retained

16 Quality Manual Resource Management Guidelines to provide instructions or procedures around: Provision of Resources Management roles, Job Descriptions, Key Roles and Responsibilities Training Education, Experience and Training to perform assigned responsibilities Outsourced Services Management responsibilities, control and review of outsourced activities and quality of purchased materials relating to regulated activities

17 Quality Manual Audits Audit process overview and key points must be defined in the quality manual. Audits Description Independent, periodic and systematic audits of regulated activities which shall be conducted internally, as well as externally at vendors. All audits are planned and conducted following written procedures and using a quality risk management approach. The criticality of risk is determined by a combination of the likelihood and impact of a process failure. Factors such as previous audit outcomes, results of regulatory inspections, deviations are inputs to determining the frequency of an audit. Auditors Description / Scope Must be able to perform their tasks in a manner that is free from interference from the internal and external stakeholders. Audit Results Shall relay to internal and external auditees, as well as appropriate functional area management. Auditee responses must address the root cause of findings, and, where applicable, must include corrections, corrective and/or preventive actions.

18 Quality Manual Corrective and Preventive Actions (CAPA) CAPA s are Key for the prevention of quality issues, such as: Deviations Product Complaints Recalls Product Rejections Regulatory Inspection findings Audit findings Trends from process performance and product quality monitoring Environmental Monitoring Laboratory Events The Quality Manual needs to describe that the approach to the investigation process is used with the objective of determining the root cause and corrective actions to prevent occurrence. The level of effort, formality, and documentation of corrective and preventive actions is commensurate with the level of risk. CAPA Management results in product and process improvements and enhanced product and process understanding.

19 Quality Manual Change Management Quality Manual identifies the purpose and scope of a change management. Purpose of Change Management Process that will ensure: proper evaluation, approval and implementation of changes in the site high degree of assurance that there are no unintended consequences of the change Change Management records shall be evaluated by subject matter experts of appropriate expertise and knowledge from relevant areas to ensure the change is technically justified. Change Management records need to be implemented. Implementation must be verified. Evaluation of the change is undertaken to confirm the change objectives were achieved and that there was no impact on product quality or patient safety

20 Quality Manual Quality Management Review Quality Management Reviews scope and frequencies must be defined. Scope The QMR shall include tracking and trending of quality metrics for assessment by the Site management, including, at minimum, representatives from Quality Assurance, Analytical Operations, Quality Control and Manufacturing Operations Leadership Team. Items requiring special attention shall be identified along with Corrective and Preventive Action plans as a feedback mechanism to continuously improve the Quality Management Systems. Frequency Frequency must be defined accordingly to site needs. From monthly to quarterly, there s no right/wrong number. It needs to be directly proportional to the quality maturity of the site.

21 Quality Manual Quality Management System QMS Subsystem Quality Laboratory Controls Key Components of Subsystem Incident Management Change Management Training Audits Document & Records Management Regulatory Inspections Escalation/FARs/Recalls Product Complaints CAPAs Data Integrity Risk Management Management Review Lab Operations Analytical Method Validation Laboratory Investigations Stability Program

22 Quality Manual QMS Subsystem Production Controls Packaging and Labeling Controls Material Controls Infrastructure Facilities, Equipment, and Utilities Key Components of Subsystem In Process Controls Process Validation Aseptic Process Cleaning Validation Master Batch Records Environmental Monitoring Packaging Controls Labeling Controls CMO/Supplier Management Specification Setting Specification Management Distribution and Transport Computerized Systems Computer System Validation Organization Roles & Responsibilities Equipment/Facility/Utilities Validation Calibration/Maintenance

23 Case Study

24 Q&A Open Discussion

25 Thank You!