Strategies to Revise Quality Policy and Quality Objectives

Eileen Cortes

February 22, 2017

Agenda

• Elements of Compliance

• Quality Policy Outline

• Quality Strategy and Objectives

• Case Study

• Open Discussion

Elements of Compliance

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

Identification of Elements of Compliance • Quality and Compliance are Different but Compliment each

other

Quality

Compliance

Quantitative

Qualitative

Identification of Elements of Compliance

• Main Elements of Compliance

• Validation

• Quality Systems

• Analytical Laboratory

• Quality Engineering

• Supply Chain

• CMO’s and Third Parties

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:

• Ethical Behavior

• Right Values

• Culture of Integrity

• HOW???

• By Implementing QUALITY

Quality Policy

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

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

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

Quality Strategies

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.

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

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

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

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.

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.

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

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.

Quality Manual • Quality Management System

QMS Subsystem Key Components of Subsystem

Quality

Incident Management

Change Management

Training

Audits

Document & Records Management

Regulatory Inspections

Escalation/FARs/Recalls

Product Complaints

CAPAs

Data Integrity

Risk Management

Management Review

Laboratory Controls

Lab Operations

Analytical Method Validation

Laboratory Investigations

Stability Program

Quality Manual

Production Controls

In Process Controls

Process Validation

Aseptic Process

Cleaning Validation

Master Batch Records

Environmental Monitoring

Packaging and Labeling Controls Packaging Controls

Labeling Controls

Material Controls

CMO/Supplier Management

Specification Setting

Specification Management

Distribution and Transport

Infrastructure

Computerized Systems

Computer System Validation

Organization Roles & Responsibilities

Facilities, Equipment, and Utilities Equipment/Facility/Utilities Validation

Calibration/Maintenance

QMS Subsystem Key Components of Subsystem

Case Study

Q&A Open Discussion

Thank You!