Infrastructure
Research & Development
Formulations
The FRnD is designed to develop various kinds of oral dosage forms like Cream, Ointment, Gel, Liniment, Lotion, Intimate wash, Hair Oil & Hair Gel, Hair Serum, under-eye serum, Face Serum and Pet (Shampoo, Cream, Lotion, Ointment) in single as well as formulations.
FRnD is fully supported by an exclusive sophisticated Analytical Research and Developmental Lab.
Well-competent team Capable of developing and transferring the product as per global regulatory norms
Analytical
The objective of the ARnD is to develop, the Analytical methods in-house for every formulation developed by the FRnD.
ARnD is equipped with sophisticated Equipment like a UV Spectrophotometer, HPLC and Auto Titrator.
As an internal quality benchmark, each of the in house developed analytical methods are validated before commercialization to ensure the consistency of the product quality is maintained everywhere, every time.
The Walk-in stability chambers in ARnD provide periodical, both real-time and accelerated stability studies as per ICH guidelines.
Best industry Documentation practices are adopted in FRnD and ARnD for the Technology transfer of products and new formulation development to deliver uncompromised high-quality formulations.
Quality Assurance
Well qualified personnel with rich expertise committed to deliver uncompromised.
Quality management system conceived as per the cGMP requirements. Stringent quality procedures and controls on the entire product life cycle from development to shelf life.
Encompasses all the critical quality assurance tools like facility qualification, equipment qualification, vendor qualification, product release, trend analysis, self inspection, market complaint, product recall, out of specification, out of trend, and annual quality review.
Deep-rooted documentation practice covering, incident reporting, deviations, change controls with CAPA as the guiding tool.
Validation is an integral part of quality assurance, associated with every product, system and process. Training of all employees for cGMP awareness on a continual basis.
Quality Control
Qualified and competent personnel with sophisticated infrastructure form the backbone of the quality control.
Exclusive chemical and instrument for the testing of API, Excipients, Packaging, In-process materials and Finished drug products
Furnished with automated and most ultra-modern apparatus including UV, KF titrator, Viscometer.
HPLCs ensure simultaneously analysis of multiple products.
Periodical monitoring to achieve environmental compliance as per the cGMP norms.
Continuous review of stability data for the entire shelf life through 226 and 250 liters of Walk-in Stability Chamber as per ICH specification.
The 24/7 Air-conditioned retention sample room under prescribed storage conditions for quality audit of all products at any time.
warehouse
Storage conditions conforming to cGMP norms to ensure quality throughout the shelf life of all materials.
Stores active raw materials, diluents, packing materials, and finished goods under controlled temperature and humidity as per specific product demand.
The material transfers through pass box to hold area.
Sampling and dispensing of materials carried out under laminar air flow in class 100.
Quarantine, under test, approved and rejected materials stored in a segregated area.
Separate recall room for storing market recall products.
production
The built-up capacity of the plant is 25 crore units inclusive of Cream, Ointment, Gel and Lotion per annum.
The facility is equipped with all kinds of equipment for Ointments Cream Mixing Filling, Liquid Filling, Shrink Wrapping unit packing and bulk packing.
Automated and PLC based equipment like Automatic Cartooning Machine packing equipment.
Dedicated storage area for dispensed materials and other in-process materials.
Dedicated AHUs and Controlled environment conditions for processing.
packing
Three packing suits for primary packing with a capacity to pack up to 2.5 million Cream, Lotions, Ointment, Gel and shampoo etc.
Equipped to handle all the packing requirements from Tube, Carton, Shipper and HDPE packing.
Most advanced PCP-90 Automatic Cartooning Machine (BQS) based on flat thermoforming and sealing, servo mechanism.
Exclusive change parts for physician samples.
All the packing machines equipped with online printers in the primary packing section
purified water plant
Installed capacity of purified water system is 2 KL per Hour. Purification process includes, Multi-grade and Activated carbon filtration, Chlorination, RO treatment, Mixed bed resin treatment and UV pass.
Distributed through continuous loop system with Zero dead leg valves.
Periodic testing and sanitization programs.