Professional Documents
Culture Documents
Good
Goodengineering
Engineeringpractice
Practice
Project Organization
Value Analysis
Design Reviews
Handover
B. Common Practices:It ensures the daily practice pattern of GEP and it includes:
Standards and Procedures
Documentation Practices
Change Management
Breakdown Maintenance
Internal Audit
A.Documentation:
Minimum level of documentation shall be maintained for all components, system and
equipment.
Each component should be inspected, tested, and documented by qualified individuals
Documentation shall cover design, fabrication, construction, inspection, and
commissioning
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
plan.
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.
Sources:
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 1922, 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. 1521.