Ortin adheres to various procedural checks and controls
to ensure that the Product is of the required Quality. This
is by our Quality Assurance Department which is well equipped
with the latest Analytical Instruments.
Ortin have laid down various in-house and Pharmacopoeial
Specifications for each step from the testing of Raw Materials
to Finished Products and also standardized and validated
all our systems like water supply, procurement of specific
ingredients, quality testing, manufacturing procedures,
cleaning procedures etc.
All the crude drugs are tested for Microscopic & Macroscopic
specifications. Phytochemical Screenings for the presence
of Activity Secondary Metabolites viz., Alkaloids, Tannins,
Flavonoids etc., and alcohol, water soluble extract, Ash
values and Volatile substances. Extracts are tested for
description, pH, water soluble extract etc.
All the finished products viz., Tablets, Capsules, Syrups,
Powders and Ointments are tested for average weights, disintegration
time, diameter, thickness, moisture, volume, color sedimentation,
taster, pH, clarity etc. We have separate Microbiological
Laboratory for testing the Microbial contamination in all
the Products.
To ensure quality, our Quality Assurance Department is
well equipped with most sophisticated, ultra-modern and
state-of-the-art instruments like:
Gas Chromatography, HPLC, FTIR, UV Spectrophotometer,
Photo Fluorometer, Dissolution Apparatus, Karl Fischer Titrator,
Humidity Control Oven, Colony Counter, D.T. Apparatus, Fumigator,
Friability Apparatus, I.R., Moisture Balance, Incubator,
Leakage Test Apparatus, Polarimeter, pH Meter, Refract meter,
Zone Reader, Autoclave, Centrifuge Machine etc.
As per GLP, all the stringent/strict quality control measures
are taken as per the specifications/measures of control
taken by any Government Lab.
The quality of the Products as raw material, semi-finished
products, and finished products are checked at every possible
step. This will eliminate any error and high quality products
are produced. In fact, an average of 25 analytical procedures
is carried out before releasing any batch. The Quality Assurance
Department has technically qualified analytical professionals,
who take utmost care to ensure the quality of products as
per GLP/GMP specifications during the process of manufacturing
as well as during shelf life. All the facilities for quality
control are available in-house, so checking of quality is
ensured at each step, in-house.
Maintaining the quality at all levels ensures the respect
and goodwill of ORTIN among the doctors and retail chemists.
In a nutshell, the key elements of our Quality Assurance
System are:
· Leadership
· Training
· Design, Construction & Installation
· Formula Cards, Specifications and Standards
· Written Procedures
· Validation
· House Keeping, Pest Control, Sanitation and Maintenance
· Starting materials
· Manufacturing operations
· Packing Operations
· Handling & Storage of Finished Products
· Laboratory Control
· Process Control
· In-Process and Finished Product release and control
· Records
· Self-Improvement Program
· Complaints
· Quality System Results tracking and improvement