GENERAL SIR JOHN KOTELAWALA DEFFENSE UNIVERSITY

DEPARTMENT OF MECHANICAL ENGINEERING

FIELD VISIT REPORT- STATE

PHARMACEUTICAL
MANUFACTURING COOPERATION
OF SRI LANKA

NAME : ALA
ROHANAPURA
INDEX NO : C/ENG/6131/ME
INTAKE : 38
STREAM : MECHANICAL
DATE OF PERFORMANCE: 30/09/2022
DATE OF SUBMISSION: 14/10/2022
1. INTRODUCTION
State Pharmaceuticals Manufacturing Corporation (SPMC) was a grant aid from the Japanese
Government through JICA and incorporated in June 1987 under the State Industrial
Corporation Act no 49 of 1957 with the commitment to manufacture quality, effective and safe
medicinal drugs at an affordable price to the public of Sri Lanka. We have now completed 30
years of continuous service of producing drugs of a superior quality conforming to the highest
international standards, and have achieved a formidable position in the field of pharmaceutical
manufacturing in Sri Lanka, with gradual growth in the pharmaceutical business. At present,
the SPMC manufactures 72 drugs under generic names, covering a wide spectrum of
pharmacological categories. SPMC is the only state sector corporation engaged in
manufacturing pharmaceuticals in Sri Lanka.
All products manufactured by SPMC have the required quality as per British Pharmacopoeia
(BP), United States Pharmacopoeia (USP), SPMC standards, and also long shelf life.
The pharmaceuticals manufacturing facility, of the SPMC which has a floor area of 50,000 sq.,
initially, increased up to 75,000 sq. Later, consisting of two separate manufacturing zones is
equipped with modern Japanese and German machines. The manufacturing facility has an
ultra-clean atmosphere and conforms to World Health Organization’s (WHO) Current Good
Manufacturing Practice (cGMP) requirements. The atmosphere of the Ultra clean Zone where
manufacture takes place is strictly controlled with regard to temperature, humidity, microbial
count, and particulate matter.
Since the inception of the organization in 1987 part of Japanese culture was harvested in the
organization that concentrates on product quality and equality among employees. As a result,
we have created an organization with unmatched team spirit and teamwork culture that helped
us to build our reputation as a manufacturer of quality pharmaceutical products, which is the
most effective force behind our success.
2. STRUCTURE OF THE ORGANIZATION

The company has a massive organizational setup. There are many departments inside
the business. And main departments are,
❖ Department of Production
❖ Department of Quality Control
❖ Department of Formulation,
❖ Department of Engineering
❖ Department of Planning and Procurement
❖ Department of Marketing
❖ Department of Finance
❖ Department of Human Resources
There are numerous further divisions under these basic departments, as may be seen in
the structure that follows.
3. MAIN TYPES OF MANUFACTURING
PROCESSES/ MAJOR SECTION
overdue Professor Senaka Bibile and Dr S A Wickramasinghe made a sturdy case for the
established order of an important drug production entity owned and controlled with the aid of
using the authorities of Sri Lanka. As a bring about 1 State Pharmaceuticals Manufacturing
Corporation (SPMC) became set up with provide resource from Japanese Government via JICA
and plant upgraded in 2018 once more with aid of JiCA. SPMC merchandise manufactured in
absolutely ready computer-managed production centers profoundly designed in compliance to
WHO modern-day Good Manufacturing Practices(cGMP) with an intensive supervision of great,
there prescription drugs are in par with the global requirements making sure the best product great.
Scientifically and technologically sound educated crew operating on a constantly growing platform
in a studies way of life with exquisite Japanese generation they make best the best great
prescription drugs to distribute via our advertising pipe lines.
4. AUTOMATION IN PHARMACEUTICAL
MANUFACTURING
State Pharmaceuticals Manufacturing Corporation (SPMC) which become a supply resource
from Japanese Government thru JICA and integrated on June 1 beneath Neath the State
Industrial Corporation Act no forty nine of 1957 with the dedication to fabricate first-class,
powerful and secure medicinal pills at low-priced rate to public of Sri Lanka. We have now
finished 30 years of non-stop carrier of manufacturing pills of advanced first-class
conforming to the very best worldwide requirements, and feature done a powerful role
withinside the discipline of pharmaceutical production in Sri Lanka, with a slow increase in
pharmaceutical business. At present, the SPMC manufactures seventy-two pills beneath
Neath regular names, overlaying a huge spectrum of pharmacological categories. SPMC is
the handiest country quarter employer engaged in production prescribed drugs in Sri Lanka.
All merchandise synthetic via way of means of SPMC have the desired first-class as in
keeping with British Pharmacopoeia (BP), United States Pharmacopoeia (USP), SPMC
requirements and additionally lengthy shelf life.
5. SAFTEY ASPECTS AND PRECAUTIONS TAKEN TO
PREVENT CONTAMINATIONS
The environment, industry employees, and patients who eat the products are all at risk from
pollution in the pharmaceutical industry. Pharmaceutical contamination can take the form of
biological components, physical pollutants, chemical contaminants, and pyrogenic chemicals.
Pharmaceutical products may contain contaminants due to the materials used, the
manufacturing facilities, the workers engaged in the production and handling process, as well
as the manufacturing techniques. There are many actions that can be taken to stop
contamination in the pharmaceutical industry. The company had improved facility layouts
where the humidity, temperature, and air filtration were correctly maintained in accordance
with standards, regular sanitization and cleaning took place, and personnel contamination was
managed because the production staff had the necessary training and was wearing protective
workwear.

6. ERGONOMICS
Workplace ergonomics issues have the potential to affect productivity, health, and safety.
Ergonomics can take one of three forms:
❖ Physical ergonomics
❖ Cognitive ergonomics
❖ Organizational ergonomics
At SPMC, ergonomics is maintained through the use of safer work equipment, workplace
design that ensures worker safety and provides a comfortable environment for employees, and
equipment that increases productivity.

7. WASTE AND HAZARD MANAGEMENT

Segregation of various laboratory wastes can enhance compliance and safety, while
introducing price financial savings. Solvents are the maximum not unusual place waste fabric
and producers attempt to get better and recycle those to lessen environmental impact.
Although now no longer as easy as different sorts of waste segregation, huge financial
savings may be accomplished through isolating solvents. In addition, price financial savings
may be realized truly via segregating pharmaceutical solids from their packaging. By
allowing the outer packaging to be recycled, sizeable financial savings and a discount in
carbon footprint may be realized. Many manufactures are careful of the auditor, and regularly
waste finally ends up as risky waste whilst the producer is uncertain of its accurate
classification – that is a high-priced fix-all. Through body of workers engagement, non-risky
substances may be diverted into preferred waste, ensuing in sizeable price and environmental
financial savings. Flexible risky waste garage can permit for potential to differ among
substances, without breaching web page guidelines or inflicting useless collections. This
affords a bendy operating way to fit the peaks and falls of various product wastes throughout
the web page.