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PHARMA PRODUCTS
We are engaged in Third Party
Manufacturing and have several principal Pharmaceutical
Manufacturing company's who are winners of several Quality
Excellence Awards and are also ISO 9001 Certified. In line with
our Philosophy of consistent improvement in quality of our
products, our principal company's have set up a
state-of-the-art manufacturing facility for meeting the GMP
requirements.
Product
List:
Methodology
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The
following are some of the elementary GMP's which are
being implemented
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- Weighing balances and
measuring equipments are carefully selected,
regularly checked and calibrated.
- Careful handling of
Raw Materials is done to minimize dust generation,
thereby prolonging efficiency and filter life and
also reducing chances of gross contamination.
- Through cleaning of
processing equipments after their use each time.
- Making use of
carefully written and understood procedures.
- Making use of clear,
concise and well laid documents.
- Proper labeling of
containers, equipments and other items used during
processing.
- Ensuring cleanliness
and good house-keeping in the surrounding area of
operation.
- Following clearing
procedures with specific attention to critical parts
of machines, equipment and packaging lines.
- Identifying problem
areas and addressing them to proper authority with
possible solutions, if any.
- Recording of
temperature and relative humidity of the area where
the different unit operations are carried out,
including storage area.
- Product labels are
distinguished by shape, colour, size and design in
order to avoid mix ups.
- Off lining batch
coding, dating and coded labels.
- Handling different
products separately.
- Avoiding frequent in
and out movement of personnel at the workplace.
- Banning of chewing
tobacco, bettlenut, gutkha etc. in manufacturing
areas.
- Ensuring that cleaning
equipments such as vacuum Extraction unit, supply of
hot and cold water, distilled water, dustbins and
preliminary machines tools (such as set of spanners
& Screwdrivers) are available at work place.
- Adequate light and air
velocity are maintained in different manufacturing
areas.
- Documents are made
available at the relevant places.
- SOP's (Standard
Operating Procedures) are written in English as well
as Regional languages, dismantling, assembling and
operations clearly written and contains only those
information applicable to that particular model of
machine. These SOP's are well displayed at workplace
after proper frame-work.
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Documentation:
- All the facts or even
untoward observations during manufacturing and
packaging area are mentioned in the job card. It is
even mentioned in Regional language, so that in case
of any complaint, same can be useful to take
corrective action and reoccurrence can be avoided.
- Different In-process
control parameters at each stage is recorded during
the processing.
- QC sampling and IPQC
records are accompanying every batch sheet.
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Dispatch:
- The said batch of
product is cleared by QC Dept.
- The yield conciliation
has been done and per cent losses are within the
specified range.
- All the documents
pertaining to the said batch of the product are
complete and signed by appropriate authorities.
- The vehicles carrying
finished good is clear enough and have necessary
full proof protection from rain and dust during
transportation.
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QUALITY
ASSURANCE & QUALITY CONTROL DEPARTMENT
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| These
departments act at manufacturing as per design
specifications and emphasis on zero-defect products. |
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QA is
largely directed at meeting goals and preventing
adverse change. QA is the activity of providing the
evidence needed to establish confidence, among all
concerned, that the quality-related activities are
being preformed effectively.
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QC
consists of observing actual performance, comparing
this performance with same standard, and then taking
action of the observed performance is significantly
different from the standard.
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| Validation
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Validation
has become mandatory for us to comply with the new
regulatory guidelines. It helps us to assure that each
batch meets its predetermined specifications, &
customer requirements; It also helps to reduce the
chance of rework and product recall. It also saves money
and time in the long run.
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| In
validating, three Qualification terms are involved : |
- IQ - Installation
Qualification.
- OQ- Operational
Qualification
- PQ - Performance
Qualification
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| The
above 3 Q's helps us to clarify the following : |
- The systems and
process are validated.
- The equipment and
materials are qualified.
- People are trained and
qualified.
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| Quality
Audits |
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It is an
imperative for enhancing productivity. Audits helps to
identify areas of risk and opportunities for improvement
as business performance. Quality audit inspection team
from several departments are set up to audit work area.
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| Training |
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All personnel
are trained and indoctrinated in the performance of the
tasks to which they are assigned. Training records are
maintained and kept up to date to review annually.
Employees are rewarded for extra ordinary achievements,
contribution or participation in the form of
remunerations or recognition.
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| Employees
participation |
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All personnel
are trained and indoctrinated in the performance of the
tasks to which they are assigned. Training records are
maintained and kept up to date to review annually.
Employees are rewarded for extra ordinary achievements,
contribution or participation in the form of
remunerations or recognition.
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| Safety
programme |
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Plant
safety programme play an important role in quality
control since hazardous conditions diminish employee
morale and performance.
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| Safety
programme consists of:- |
| - An
active, continuing safety campaign through out the plant
including |
- Posters displayed
permanently.
- Safety bulletin boards
listing recent plant accidents and method of
prevention.
- Safety inspection
teams from several departments to audit work area.
- Lectures and movies.
- Availability of safety
equipments.
- Identifications of
all service lines such as water, gas, vacuum
waste, steam electricity communication,
including direction of flow.
- Fire extinguish
for all types of fire in each department .
- In plant alarm,
emergency light generators.
- Emergency teams,
including fire and first aid..
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We
purchase bulk active Ingredients, excipients and packing
materials from reputed manufacturing companies. These
materials are sampled and send to reputed public testing
labs, on the receipt of materials approval, we supply
these to our principal companies for manufacturing our
required production.
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We have
qualified and experienced personnel who supervises all
the manufacturing process from raw materials stage to
finished goods stage. Samples from finished goods are
sent to public labs for testing of each and every batch,
after receipt of approval, the products are duly pack in
export Sea/Air worthy packing and they are duly labeled
as desired by the customer.
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We
personally take care of all the dispatch process like
transportation from work to Sea/Air port. Third party
inspection, custom clearance upto final dispatch.
We take care of all the
quality measures which will give best quality
fulfillment and complete satisfaction to our clients as
Quality is necessity and the basic feint of our
business. |
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