-KOJACH PHARMA PROJECT

ORAL SOLID DOSAGE FACILITY

PEAR ENG. SERVICES

B.ODAMTTEN

PROJECT SCHEDULE

DRAFT FOR REVIEW

FOREWORD

This purpose of this document is to serve as a guide towards the design, procurement, installation,
commissioning and operation of pharmaco / service equipments and utility services as per World Health
Organization (WHO) GMP guidelines and International Society for Pharmaceutical Engineers (ISPE)
Baseline® Pharmaceutical Guide for New and Renovated Facilities.

The reference material for this project is based on volume 5 of the Implementation Guide for Installation
and Verification of Facilities/Utilities and Equipment Systems and volume 146 Good Design Practices for
GMP Pharmaceutical Facilities.

Facilities that effectively incorporate Good Engineering Practices (GEP) and Good Manufacturing
Practices (GMP) are easily licensed and thus bring the project on stream in a timely fashion. The
engineering and validation protocols under the GEP and GMP disciplines are key factors in the
development of Validation Master Plan (VMP) of the facility.

I recommend the setting up of two committees namely, Project Implementation and Good Manufacturing
Practices (GMP). The first committee mandate ends after the project completion whilst the latter would
be assimilated into the operational activities of the facility.

Together we would see this project through to the operational stage and would require the tacit support of
management and subject matter experts (SME).

Ben Odamtten

Tech. Director

Pear Engineering Services

 CONTENT

1. FACILITY PLANNING

2. DOCUMENTATION REQUIREMENT AND SCHEDULE

3. PROJECT MANAGEMENT

4. PHARMACO EQUIPMENTS

5. MECHANICAL AND SERVICE EQUIPMENTS (UTILITITES)

6. ENGINEERING OPERATIONS FOR FACILITY ON STREAM

7. RESOURCES

PAGE 1
1. FACILITY PLANNING

Facilities represent a large capital cost and fixed investments for the company and would be prudent to
know these key points from the owner

 Strategic goals of the company

 Business case for action
 Options ‘on what to do
 Presentation of planning process to relevant members

1.1 PROJECT PLAN FROM A BUSINESS CASE

Process Step Business Case Manufacturing Plan .Source Facility

Project
. Build
How much, Planning
Company Business Plan .Internal/External
When and How

Operations/Tax Exemptions
Regulation Strategy

Senior management/Market/Sales Planning/Operations

.Management Expectations

.Engineering and Operations

.Deliverables

Board/Senior Management

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1.1 TYPICAL PHARMACEUTICAL FACILITY COST PROFILE

CIVIL STRUCTURE ENGINEERING ELECTRICAL

CONSULTANCY MECHANICAL

The above flow diagram and pie chart would be discussed as part of the review process and

decision taken.

Page 3
1.2 SECURITY:

Providing a safe and secure work environment requires q combination of physical security measures,
administrative controls and personal ownership. The degree of success for any program is dependent upon
the partnership between management and staff. Management must be committed to providing the necessary
resources to identify and control security risk to an acceptable level. Staff must be willing to take ownership
of the security program and ensure with the requirements.

Points to Consider

1. 1.2MANNED CONTROL ROOM

A. Monitoring all access control points

B. Monitoring all internal communications
C. Monitoring and recording all CCTV data
D. Monitoring all building operations systems
E. Monitoring all life safety systems
F. Monitoring all incoming calls to the control room

2.1.2 SURVEILLANCE SYSTEMS

A. Closed Circuit Television Camera (a) Strategically placed to cover potential exposures and
vulnerabilities ( critical areas, lobby, corridor, loading docks, building entrances, mechanical
equipment areas, parking lots grounds and perimeter fence line.
B. Equipment that is capable of high resolution, low light and night vision
C. Digital equipment with 1:1 recording capabilities
D. PTZ (pan, tilt, zoom) equipment
E. Use of passive/disguise units
F. Break glass detectors
G. Motion/sound detectors

Page 4
3. ACCESS CONTROL

3.1 Control Systems

A. Key
B. Keypad
C. Photo ID
D. Photo ID plus proximity card reader
E. Photo ID , proximity card reader plus keypad
F. Photo ID , proximity card reader plus biometric
G. Time sensitive Photo ID system for visitors and service providers

3.2 HARDWARE

A. Basic lock system

B. Removable core lock system
C. Local keypad lock system
D. Centralized electronic magnetic lock system

3.3 ACCESS CONTROL POINTS

A. Perimeter vehicle/pedestrian gates

B. Lobby
C. Loading docks
D. Plant rooms
E. Storage vaults for narcotics

3.4 PERSONNEL SECURITY

BACKGROUND CHECKS

A. Employees
B. Contract staff
C. Construction (pre-approved list of authorized individuals
D. Outside service providers

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3.5 VISITORS

A. Temporary Photo ID
B. Escort Policy

3.6 INDIVIDUAL RESPONSIBILITIES AND ACCOUNTABILITIES

A. Develop and implement a security policy

B. Policy needs management endorsement and approval

3.7 WORKPLACE VIOLENCE

A. Develop, implement and communicate a work place code of conduct and work ethics policy.
2. DOCUMENTATION REQUIREMENT AND SCHEDULE

As per World Health Organization (WHO) GMP and International Society for Pharmaceutical Engineers
(ISPE) guidelines for Solid Dosage Facility the documentation schedule as prescribed under these disciplines
is as follows:

FOR THE FACILITY:

A. Architectural Drawings (conceptual and as-built)

B. Building Permit
C. Fire Plan, Fire Certification and Emergency Response plan

PHARMACO EQUIPMENTS

A. Design Qualification (DQ)

B. Installation Qualification (IQ)
C. Operational/Performance Qualification