-KOJACH PHARMA PROJECT

ORAL SOLID DOSAGE FACILITY

11/23/2010 PEAR ENG. SERVICES
B.ODAMTTEN

PROJECT SCHEDULE DRAFT FOR REVIEW

Director Pear Engineering Services . The first committee mandate ends after the project completion whilst the latter would be assimilated into the operational activities of the facility. procurement. 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. I recommend the setting up of two committees namely. Ben Odamtten Tech. 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. Together we would see this project through to the operational stage and would require the tacit support of management and subject matter experts (SME). Project Implementation and Good Manufacturing Practices (GMP). installation.FOREWORD This purpose of this document is to serve as a guide towards the design. 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. 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.

RESOURCES PAGE 1 . MECHANICAL AND SERVICE EQUIPMENTS (UTILITITES) 6. DOCUMENTATION REQUIREMENT AND SCHEDULE 3. FACILITY PLANNING 2. PHARMACO EQUIPMENTS 5.CONTENT 1. PROJECT MANAGEMENT 4. ENGINEERING OPERATIONS FOR FACILITY ON STREAM 7.

Build Facility Project Planning Company Business Plan How much. 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 µon what to do Presentation of planning process to relevant members 1. When and How .Internal/External Regulation Strategy Operations/Tax Exemptions Senior management/Market/Sales Planning/Operations .Management Expectations .Deliverables Board/Senior Management PAGE 2 .1.Source .Engineering and Operations .1 PROJECT PLAN FROM A BUSINESS CASE Process Step Business Case Manufacturing Plan .

1.1 TYPICAL PHARMACEUTICAL FACILITY COST PROFILE 40% 25% 10% 10% 15% 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 .

The degree of success for any program is dependent upon the partnership between management and staff. zoom) equipment E. Points to Consider 1. Motion/sound detectors Page 4 . Monitoring all internal communications C. loading docks. mechanical equipment areas. low light and night vision C. Monitoring and recording all CCTV data D. Monitoring all building operations systems E. Monitoring all life safety systems F.2 SURVEILLANCE SYSTEMS A. 1. corridor. Monitoring all access control points B. Use of passive/disguise units F. B. Equipment that is capable of high resolution. Management must be committed to providing the necessary resources to identify and control security risk to an acceptable level.2 SECURITY: Providing a safe and secure work environment requires q combination of physical security measures. administrative controls and personal ownership. Staff must be willing to take ownership of the security program and ensure with the requirements. Break glass detectors G. Closed Circuit Television Camera (a) Strategically placed to cover potential exposures and vulnerabilities ( critical areas. tilt. building entrances.1. lobby. PTZ (pan. Monitoring all incoming calls to the control room 2.1. Digital equipment with 1:1 recording capabilities D. parking lots grounds and perimeter fence line.2MANNED CONTROL ROOM A.

2 HARDWARE A. Outside service providers Page 5 . proximity card reader plus biometric G. Photo ID .3 ACCESS CONTROL POINTS A. Removable core lock system C. Photo ID D. Keypad C. Loading docks D. Storage vaults for narcotics 3. Local keypad lock system D.1 Control Systems A. Lobby C. ACCESS CONTROL 3.3. Plant rooms E. Key B. Contract staff C. Basic lock system B. Centralized electronic magnetic lock system 3. Photo ID plus proximity card reader E. Employees B. Construction (pre-approved list of authorized individuals D. proximity card reader plus keypad F.4 PERSONNEL SECURITY BACKGROUND CHECKS A. Photo ID . Time sensitive Photo ID system for visitors and service providers 3. Perimeter vehicle/pedestrian gates B.

implement and communicate a work place code of conduct and work ethics policy. Temporary Photo ID B.6 INDIVIDUAL RESPONSIBILITIES AND ACCOUNTABILITIES A. Develop.3. .7 WORKPLACE VIOLENCE A.5 VISITORS A. Escort Policy 3. Develop and implement a security policy B. Policy needs management endorsement and approval 3.

Design Qualification (DQ) B.2. Building Permit C. Architectural Drawings (conceptual and as-built) B. 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. Fire Plan. Fire Certification and Emergency Response plan PHARMACO EQUIPMENTS A. Operational/Performance Qualification . Installation Qualification (IQ) C.

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