Developing A New Pharmaceutical Facility in Eastern Europe: by Prakash Davda
Developing A New Pharmaceutical Facility in Eastern Europe: by Prakash Davda
Developing A New Pharmaceutical Facility in Eastern Europe: by Prakash Davda
issues
T
Introduction The Brief
his article presents a case study of the The requirement was to design and build a new
issues to be addressed when designing tablet production plant on an existing pharma-
and constructing a new pharmaceuti- ceutical site in Bulgaria to produce approxi-
cal production facility in Eastern Eu- mately three billion tablets per year for large
rope. Solutions to the expected difficulties were volume generic formulations of plain or coated
developed which overcame the differences be- types with possible addition of hard gelatine
tween Eastern and Western European meth- capsules and effervescent tablets at a later
ods and standards. This applied particularly to date.
cGMP, regulatory issues, construction time, Key criteria were to:
cost, quality, available materials, codes, cul-
ture, contractual ethos, and language. have the facility in production as soon as
practically possible
Figure 1. Production of
coated or non coated create flexible space
tablets by direct with a capability for ex-
compression and wet pansion
granulation.
provide cost effective
construction with low
maintenance and energy
costs
Protocol No 3 - the site book/diary certified from the National approved detail drawings and statement of compliance
Building Supervision Directorate is issued for recording with the design parameters
all future activities.
Results from 72 hours test on all services. Acceptance
Protocol No 4 - formal hand over/acceptance of all technical Certificate for completion of all works from the relevant
documentation. authorities including the incoming services supply com-
pany, the Regional Inspectorate for Environment and
Protocol No 5 - statement for the building terrain certifying Waters etc.
and complying with the detail drawings setting out base
building coordinates. statements of completion from the Main Contractor
Protocol No 6 - statement certifying soil category and actual proof of ownership and permission to build on territory
excavating working levels. of someone elses property if applicable
Protocol No 7 - statement for acceptance of the actual build- environmental impact assessment
ing/assembling works by levels and details.
card for assessment of influence on site environment in
Protocol No 8 - statement for acceptance of the foundation comparison with the original samples taken at the start
works for construction.
certificate for achieving the set design parameters
Protocol No 9 - statement for acceptance of the shuttering, within the whole facility
reinforcement and welded works.
statement from Occupational Health and Safety Au-
Protocol No 10 - deviations from the design dimensions thorities allowing the building to go into operation
according to Regulation No 3 for the acceptance of the
concrete works. statement from the Fire Fighting Emergency Regional
Service
Protocol No 11 - statement for the acceptance and transfer of
equipment. document issued by the Cadastre Agency (Local County)
for building survey, underground technical systems,
Protocol No 12 - statement for determining the building and equipment survey in attendance with the Cadastre
condition in case of stopping. Agency
letter of appointment from the employer confirming the A local consultant in Bulgaria was employed through the
staff employed, inclusive of log for health and safety detail design process to assist in converting the necessary
induction for all staff information into Bulgarian for local authority approvals, and
assist with interpretation where necessary to ensure the
statement from the Chief Architect of the municipality designs met with the local codes and standards.
for law conformity, validity of issued construction docu- The operating company and UK design company agreed
ments, and conformity of performance with the above that no compromises should be made on material and equip-
documents, and for compliance with the requirements ment selection, and that they would be in line with what
of Article 68, Article 178, Paragraph 3 of the Law of would be used in Western Europe. However, the operating
Territory Management company requested that every effort must be made to source
as much material locally as possible.
statement from the designers confirming compliance of The complete project was overseen by the UK companys
their respective design to the finished works project manager on a visiting basis throughout the detail
design, procurement, construction, commissioning, and vali-
Protocol No 16 - (where applicable) Certificate for establish- dation with a very hands on approach with the operating
ing the suitability of the building for use. This certificate companys project manager supervising the day to day issues
is drawn up by the employees assigned by the chief of on site.
National Construction Control Directorate or authorized The detail design was prepared in 45 packages to allow
by him/her employee whose name is included in the Letter early start on site and provide better control of subcontrac-
of Appointment for State Acceptance Commission in line tors although this caused difficulties with local authority
with Ordinance No 6 of 2001 for issuing Permission to Use approvals. However, the situation was managed.
the Building in Republic of Bulgaria. To assist the project with professional procurement ser-
vices, a quantity surveyor was needed. In Bulgaria, quantity
Protocol No 17 - (where applicable) Certificate of completing surveying is not a recognized profession. However, an expa-
any non compliances/defects based on the decisions of triate quantity surveyor was sourced and hired to assist with
State Acceptance Commission under Protocol 16. the procurement, cost reporting, and administer the tender
process.
The operating companys in-house engineering resources Each work package was tendered individually. The com-
assisted with this complete process. panies were selected by placing several advertisements in
local and national newspapers inviting them to formally
Detail Design and Construction show their interest. Short lists of six companies were selected
The detailed design drawings and specifications were pro- for each package by interviewing up to eight companies. The
duced in the UK with support from two Bulgarian architec- selection criteria included review of their past experience,
tural technicians to assist translation of codes into English. management capability, engineering and technical exper-
The authorities stipulate that all designs by foreigners tise, labor skills, resources availability, responsiveness, abil-
must be certified by local designers and a local independent ity to work with English drawings and specifications, quality
supervisor must ensure correct implementation of work on of past work and documentation, demonstration of team
site in compliance with local codes and maintain a fully working, financial status, cost etc.
itemized site diary of all events.
Observations and Recommendations 9. Some locals were initially apprehensive about working
1. There are excellent engineering skills in Eastern Europe, with western organizations, and particularly about being
but their normal design standards are generally quite supervised by UK employees. However, experience dem-
conservative. Western European skills can bring more onstrated that with a careful tactical approach and sensi-
finesse and higher technical inputs to the design
(c) Concrete mixing plant was not efficient and the floor
slabs had to be laid in several small sections and took
Figure 6. Completed facility.
considerable amount of coordination, engineering,
tivity about remuneration differentials, this could be and time.
overcome.
(d) The steel work grade specified was European. How-
10. Daily and weekly monitoring of short and long term ever, the contractor did not order the specified quality
program was a mandatory task as reliance could not be and quantity. This caused some delay.
placed purely on reported progress by contractors.
(e) Items such as safety wear, door seals, and ceiling clips
11. Working to a budget, program and ensuring quality was were all difficult to obtain locally.
a new concept for the locals and required constant re-
minding from the management team. (f) The contractors were not used to complying exactly
with specifications, e.g., all external doors had to be
12. Local materials are worth investigating if time is avail- changed twice as they were delivered to the wrong
able as they are cost effective. However, quality is ques- specification and color. All ceiling tiles had to be
tionable. replaced for the same reason.
13. The site was purported to be a clear brown field site, yet (g) Local pipe/ductwork fabrication and quality of mate-
more than 100 hundred barrels of contaminated waste rial inclusive of insulation appeared dubious. The
and a nuclear fall out shelter were found in the ground. quality of installation was also not to a good standard.
These were not identified in the topographic and
geotechnical investigations by local companies. (h) The wall finishes took more than four attempts to get to
an acceptable level of quality.
14. The Fire Authority would not accept boarded structural
columns to obtain the fire resistance. Hence, they had to (i) All antistatic floors had to be re-laid by using a British
be concrete encased. In some areas, solutions offered for contractor as the specification could not be achieved.
fire protection were not acceptable. However, after con-
siderable negotiations and justification, some were fi- (j) The welding on the medium temperature hot water
nally accepted. and chilled water pipe work was poor such that a high
level of resistance was encountered on the system and
15. The local consultant let the process down in some aspects the pumps had to be increased in duties to avoid delay
of approvals due to their lack of experience and knowledge to the program.
of their own regulations.
Results
16. The water supply quality was found to be inconsistent Despite the inherent difficulties of designing and construct-
and unreliable. Therefore, a 50 micron back wash pre- ing a facility of this type in Eastern Europe, with a positive