A Proposal for A Quality Management System – Based on Acquisition of ABC Company

A Proposal for A Quality Management System – A Proposal for A Quality Management System – Based on Acquisition of ABC Company from 123ABC CompanyBased on Acquisition of ABC Company from 123ABC Company

Presented By: Shyam Mohamed

Introduction Introduction

This presentation will introduce you to a new Quality Organization and Quality Management System for ABC Comp. , as this organization has become part of 123ABC new Company.

2Author: Shyam Mohamed, MSc., CSSGM

AgendaAgenda

1. The Proposed Quality Organization Structure 2. The Proposed Quality Management System

Structure 3. The Resources Needed to Implement the

Quality Management System 4. How will the Quality System be Implemented? 5. What Will Be Gain from Implementing the

Quality System?


The Quality Organization and Quality Management System (QMS) - Increase effectiveness and efficiency within the organization

Overview Overview

Auditing

QualityData

QAPolicy

Customer

SOP

ManualQC

The Structure of the Quality Organization and the QMS has an Direct Impact on the Quality especially on the Quality of the Products and Services the organization offers to the customers


Groups In The Quality Organization And Their Respective Functions Groups In The Quality Organization And Their Respective Functions


The Proposed Quality Management The Proposed Quality Management System Structure System Structure

The Quality Management System (QMS) can be described as a collective of processes, procedures, actions and resources needed to ensure and control all matters required for quality confidence.

It is a collective methodology to facilitate the appropriate structures are in place to ensure Quality.


The Proposed Quality Management The Proposed Quality Management System Structure System Structure

ABC is to define their QMS documentation structure based on their needs but also taking into considering their parent 123ABC’s Policy.

One proposed structure is a hierarchy of documents which includes:– Quality Policy,

– Quality Manual,

– Operational documents,

– Data . This QMS documentation structure will amplify Quality,

thereby having a positive impact on the Quality Systems and potentially the GMPs.


The Proposed Quality Management The Proposed Quality Management System Documentation Structure System Documentation Structure


The Importance of Instituting a New The Importance of Instituting a New Quality System for ABCQuality System for ABC

It is important for ABC to institute a new QMS because it:– Outlines upper Management responsibilities within

the new organization – Outlines the availability of personnel and resources– Defines the structure of the organization– Help build a customer-centric organization– Promotes continuous improvement – Promotes cooperation between sites

Keep in mind ABC needs to align its Quality Organization to that of its parent organization


The Quality PolicyThe Quality Policy

The proposal of the Quality Policy comes from the Executive Management (CEO) of the parent company, 123ABC for reasons mentioned above.

The Quality Policy is a high level document. It contains the mission and vision statement of the organization.

The tenets of the Quality Policy are built into the documentation system of the corporate (global) and local organizations.

Local organization such as ABC must adopt this policy and/or develop their own with the approval of the Executive Management of 123ABC.


The Proposed Quality ManualThe Proposed Quality ManualTable of Contents 1.0 QUALITY MANUAL OVERVIEW

QM 1.1: Distribution ListQM 1.2: The Quality Management Documentation SystemQM 1.3: Quality Policy StatementQM 1.4: The Quality Manual – Introduction

2.0 QUALITY MANUAL: THE ORGANISATION 3.0 QUALITY MANUAL: THE MANUFACTURING FACILITY

QM 3.1: PremisesQM 3.2: Contamination ControlQM 3.3: EquipmentQM 3.4: Production Support Utilities

4.0 QUALITY MANUAL: THE QUALITY SYSTEMQM 4.1: Description of the Quality System QM 4.2: Roles and Responsibilities of Management and PersonnelQM 4.3: Change Control GuidelinesQM 4.4: Document Control Guidelines


The Proposed Quality ManualThe Proposed Quality ManualTable of Contents (Continued) QM 4.5: Purchasing and Vendor Assurance Guidelines

QM 4.6: Material and Product Identification and Traceability GuidelinesQM 4.7: Process Control Program GuidelinesQM 4.8: Inspection and Test Program GuidelinesQM 4.9: Calibration Program GuidelinesQM 4.10: Inspection and Test Status Guidelines QM 4.11: Control of Non-Conforming Product Guidelines QM 4.12: Corrective and Preventive Action Systems GuidelinesQM 4.13: Handling and Storage of Materials and Products Guidelines QM 4.14: Control of Quality Records Guidelines QM 4.15: Internal Quality Audits Guidelines QM 4.16: Training Programmes Guidelines QM 4.18: Computer Systems Management Guidelines QM 4.19: Facility Control Guidelines QM 4.20: Management of Production Equipment and Critical Process Utilities GuidelinesQM 4.21: Continuous Quality ImprovementsQM 4.22: Validation Program GuidelinesQM 4.23: Occupational Safety and Health Program Guidelines

5.0 QUALITY MANUAL: REVISION HISTORY


The Quality System Activities, Initiatives, And The Quality System Activities, Initiatives, And Testing Testing

Based on common industry practices and common organization structure these activities, initiatives, and testing are categorized into:

– Quality Planning– Quality Control

– Quality Assurance

14

Quality Assurance

Quality ControlQuality Planning

QMS

Author: Shyam Mohamed, MSc., CSSGM

The Quality System Activities, Initiatives, And The Quality System Activities, Initiatives, And Testing Testing

While Quality Planning, Quality Control and Quality Assurance are all part of the Quality Management system there are differences that lies in the objective of each. – Quality planning oversee the objectives (goals), and target

(metrics) requirements and establishing the means to accomplish them.

– Quality Control deals more at the operational level and tends to traditionally, be more reactive i.e. it employs technical practices and procedures on how to comply with the quality requirements set forth by regulators, the organization or the customer.

– Quality Assurance deals with providing evidence to establish confidence that the quality requirements are met and should involve proactive approach to Quality.


Addressing FDA Sanctions Involved With Both Addressing FDA Sanctions Involved With Both Companies Before And After the Acquisition Companies Before And After the Acquisition

Prior to the acquisition, ABC and 123ABC addressed their own FDA sanctions such as consent decrees, 483s, warning letters, etc.

However, after the acquisition all of ABC sanctions (non found) will now become 123ABC’s concern. – If there were any sanctions:

These can be handle base on an individual basis of specific concerns

Based on legal agreement between the two organizations to have 123ABC inherit all sanctions.


The Resources Needed to Implement the The Resources Needed to Implement the Quality Management SystemQuality Management System

Personnel : You need people to implement the QMS. Project team - Composing of a cross functional group of Managers– Team lead by a representative from 123ABC…re-

shuffling of position due to redundancy Budget: Budget set aside for implementation to

cover cost Time: Time needed to perform gap assessment

and remediation.


A Proposed Timeline For ImplementationA Proposed Timeline For Implementation

18

Timeline for implementation is dependent on the findings from the gap assessment

No magic formula for a specific time line for acquisitions However, specific actions must be done and this may

have some form of timeline


How will the Quality System be How will the Quality System be Implemented?Implemented?

In Phases!– Support from Top Management– Understanding the existing process– Clear communication– Involvement of everyone in the process

– Follow up and review– Audit the implementation


What Will Be Gain From Implementing What Will Be Gain From Implementing the Quality System? the Quality System?

There are many benefits expected from implementing a Quality System : – Increased Efficiency– Increased Revenue– Elevated Morale of the employees

– Using Factual and scientific approach to making decisions

– Increase awareness and documentation compliance– Provide a forum for consistency– Improvement Processes– Regulatory Compliance 20


How Will The Quality Organization Structure And Quality System How Will The Quality Organization Structure And Quality System Provided A Means To Identify, Measure, Control, And Improve Provided A Means To Identify, Measure, Control, And Improve The Pharmaceutical Processes?The Pharmaceutical Processes?

Quality organization structure and Quality System provides a means to identify, measure, control, and improve the pharmaceutical processes

Quality organization supports and works with the QMS to identify the roles, responsibilities, accountability, contributors and who needs to be informed in an organization of what needs to be measures, controlled and improved

Improvements are based on a feedback loop from a modified Deming’s cycle i.e. Plan-Do-Check-Act-Improve

21

Do

Check

Act

Improve

Plan


How Will The Quality Organization Structure And Quality System How Will The Quality Organization Structure And Quality System Provided A Means To Identify, Measure, Control, And Improve Provided A Means To Identify, Measure, Control, And Improve The Pharmaceutical Processes?The Pharmaceutical Processes?

The QMS identifies those systems that must be measured and reported

Once these metrics are reported, managers must act to ensure these metrics do not exceed their limits or must demonstrate that they are working to bring the metric (i.e. measurement of the Quality Systems) into conformance

By doing so, they are demonstrating that the Quality Organization structure and Quality System provides a means to identify, measure, control, and improve the pharmaceutical processes 2222


ReferencesReferences

Schmidt, Oliver, “GMP / ISO Quality Systems for Drug Products Manufacturers” chap. 3 in Pharmaceutical Quality Systems, Interpharm/CRC, New York: CRC Press, 2000.

http://www.businessballs.com/dtiresources/quality_management_systems_QMS.pdf, Businessballs.com, “Quality Management Systems”, by Department of Trade, UK, as of 17/04/2010.

http://www.metricstream.com/whitepapers/html/pharma_issues.htm, Metricstream.com, “MetricStream's Quality Solutions - Power Your Enterprise: Pharmaceuticals: Issues, Perspectives & A Powerful Enterprise Solution”, as of 20/04/2010.

http://ezinearticles.com/?Quality-Management---The-Benefits-of-an-Effective-ISO-9000-Quality-Management-System&id=2355358, ezinearticles.com, “Quality Management - The Benefits of an Effective ISO 9000 Quality Management System”, by Davis Woodruff, as of 21/04/2010.


http://www.businessballs.com/dtiresources/quality_management_systems_QMS.pdf

http://www.metricstream.com/whitepapers/html/pharma_issues.htm

http://ezinearticles.com/?Quality-Management---The-Benefits-of-an-Effective-ISO-9000-Quality-Management-System&id=2355358

ReferencesReferences

http://apic.cefic.org/pub/2QualityMgtSystGMP9712.pdf, apic.cefic.org, “Quality Management System for Active pharmaceutical Ingredients manufacturers” as of 19/04/2010.


http://apic.cefic.org/pub/2QualityMgtSystGMP9712.pdf

A Proposal for A Quality Management System – Based on Acquisition of ABC Company

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