It is our endeavor to deliver products
of highest quality standards and ensure that aspects of GMP are followed
at every stage to get the intended quality. The company has formed
its Quality Policy which lays out minimum criteria to meet highest
level of Quality Objective.
Written down procedures – SOPs are laid out for every activity
that is carried out in the premises in order to maintain Quality systems.
These procedures cover activities such as stores, Production, Quality
Control, Quality Assurance and Maintenance. All personnel are well
trained in all aspects of cGMP and in areas relevant to their activities.
The company is fully equipped with latest instruments in its
Quality Control Laboratories consisting of separate Chemical,
Instrumentation, Microbiology and Sterility, IPQC laboratories.
Specifications and test methods are laid down for all raw material,
packing material, inprocess materials and finished products
and all testing are done as per laid down specifications.
The company has prepared and follows a Master Validation Plan which
includes validation of Equipment Qualification, Validation of Water
System, Process Validation, Analytical Method Validation, Cleaning
Validation and Air Handling System Validation.
Quality Assurance system
is in order to ensure the product retains Quality Characteristics
till the prescribed shelf life. In-house Accelerated and Real
time Stability studies are regularly carried out in accordance
to ICH guidelines.