A vital concern of Pharmaceutical Industries of Bangladesh
Quamruzzaman, President, Incepta Bioscience, Dhaka

Pharmaceutical manufacturing in Bangladesh is expanding rapidly and meeting international
standards since the last decade. The knowledge and implementation of good manufacturing
practices/current good manufacturing practices (GMPs/cGMPs) are pre requisite for ensuring
safety and efficacy of drug products. The demonstration of maintaining consistency of intended
quality attributes of products can be achieved through quality management tools and good
engineering practices (GEP). This provides knowledge require in the upcoming year to achieve
operation excellence. GEP is not mandated by GMP regulations. However, effective
implementation and use of GEP principles improve project outcomes, team productivity, cost
efficiencies, and also drives technological innovation and compliance. GEP underpins activities
in the day-to-day operations and forward planning of a pharmaceutical business. In addition,
GEP documentation can be leveraged to support verification work.
Good engineering practice" or "GEP" is engineering and technical activities that ensure that a
company manufactures products of the required quality as expected (e.g., by the relevant
regulatory authorities). Good engineering practices are to ensure that the development and/or
manufacturing effort consistently generates deliverables that support the requirements for
qualification or validation. Good engineering practices are applied to all industries that require
The activities of GEP can be sub segmented into three sections and each section is prefaced with
the definition of the practice. Within each section common practices and sub-practices are
identified to provide illustrative examples of GEP. The segmentation can be as follows:


Project Engineering Common Practices Operation and Maintenance

A. Project Engineering: It bridges the boundaries between engineering and project
management, leading the technical workers who contribute to the building of structures
or products. In some cases, the project engineer is the same as a project manager but in
most cases these two professionals have joint responsibility for leading a project. Project
management holds responsibility of every field of engineers. It includes:
 Project Infrastructure

 Project Organization

 Value Analysis

 Planning and Monitoring

 Design Reviews

 Handover
B. Common Practices:It ensures the daily practice pattern of GEP and it includes:
 Standards and Procedures

 Documentation Practices

 Change Management

 Innovation and Continuous Improvement
C. Operation and Maintenance: It is a continuous process under surveillance and it
 Engineering Manuals and Records

 Breakdown Maintenance

 Internal Audit

 Equipment Decommissioning and Retirement
GEP activities also focused on three core activities, namely:
 Risk Management
 Cost Management
 Organization and Control
So, GEP especially concerned with specifications, design, and installation activities, and should
take full account of all applicable requirements, including; GxP, safety, health, environmental,
ergonomic, operational, maintenance, recognized industry standards, and other statutory
Adequate provisions related to quality should be included in specifications, design, procurement,
and other contractual documents for engineered systems. Life-cycle documentation covering
planning, specifications, design, verification, installation, acceptance, and maintenance should
also be the attributes of GEP.
For the implementation of GEP maintain the following steps is mandatory:
A. Documentation
B. Requirements assessment
C. Design and construction
D. Project Control
E.Commissioning and Qualification
F.Project Closeout and turnover

 Minimum level of documentation shall be maintained for all components, system and
 Each component should be inspected, tested, and documented by qualified individuals
 Documentation shall cover design, fabrication, construction, inspection, and
 Clear understanding of documentation eliminates redundancy.
 If Documentations are appropriately planned, created, organized, and authorized, these
become an integral part of qualification support documentation for “Direct Impact”
system. Direct Impact system requires “enhanced Documentation”.
 Enhanced documentation is achieved through the qualification process, which begins in
design and culminates with qualification (IQ, OQ and PQ) and change control.
B. Requirements assessment: GEP covers the scope ofdocumentation and monitor user
requirements, Product and/or process requirements, Operational considerations, Maintenance and
technical support requirements, Operational considerations, Deliverables and Project execution
C. Design and construction: Conceptual, detailed (Piping and Instrumentation diagrams)
design, construction drawings. In the construction phase project quality control is important and
starts with the prequalification of appropriate suppliers, contractors, construction management
firms, list of quality documents, methods of identifying, notifying, and tracking the resolution of
quality deviations, plan for material and equipment receipt , verification and report, shop
drawing procedures and responsibilities, FAT, pre Installation meetings, operational checks,
punch-list management, Safety,
D. Project Control: In GEP “Engineering Change Management” is an important part. It may
contain: Record the name of the originator and date, describe the change, the effected system or
area, and intended purpose, Assess the potential impact of the change, Notify others who needs
to know the proposed change, record the approval or denial of proposed changes, track through
completion and change control.
E. Commissioning and Qualification: Development and execution of Commissioning plan and
qualification plan (e.g. Validation Master Plan) as an integral part of project plan and schedule.
F. Closeout and turnover: The following is a list of deliverables which should be included:
 Final release and report
 Certificate of occupancy
 Finalized Punch list
 Signed project acceptance
 Subcontractor evaluation report
 Lessons learned
 System manuals, facility qualification package
 “As Built” drawings and specifications
There is no denying for the improvement of GEP in pharmaceuticals industries as
Bangladesh is now considered as drug exporting country. The first “Common Practice” or
component of institutionalizing effective GEP in an engineering organization that is looking
to gain the full benefit of GEP is to have written standards and procedures for the key aspects
of GEP. These are policies, standards, procedures, and “Engineering Quality Management
System” (EQMS). The “Engineering Quality Management System” should be supported by
the same controls (i.e., document review, approval, change management, Engineering
Change Request (ECR), storage / retrieval control, training, etc.) for documents and
documentation utilized in a Pharmaceutical manufacturing environment for their Quality
Management System. EQMS policies and procedures enhance the standardization of best
practices in Pharmaceutical manufacturing organization and can lead to ‘operational
excellence’. The EQMS establishes the foundation for a highly effective, documented, and
executed design, specifications and verification process. This will result in consistently
delivering and achieving cost-effective engineered solutions that meet the critical user-
defined requirements for assuring that the system (i.e., facility, utilities, process, BMS/EMS,
computer system, etc.) is fit for its intended use. (3) This globally-reviewed document was
developed through the collaboration of professionals from various sectors and geographic
regions of the pharmaceutical industry with the intention of determining a common
understanding of the concept and principles of GEP (2). Adhering with GEP ease out practice
of GMP and has impact on Cost reduction maintains regulatory in compliant. For the
implementation of this GEP the pharmaceutical sectors require an administrative and skilled
support from all concerned drug manufacturing venture as well as from government.
1. ISPE Pharmaceutical engineering guide for new and renovated facility. Volume 5,
1st Edition, March 2001.
2. National Society of Professional Engineers. Retrieved 20 November 2014.
3. Herbst, Andrew; Hans Verwijs (Oct 19–22, 2011). "Project Engineering:
Interdisciplinary Coordination and Overall Engineering Quality Control". Proc. of
the Annual IAC conference of the American Society for Engineering
Management. 1. pp. 15–21.