Quality Control

Quality Control Laboratories:

Our Quality Control laboratories are well equipped with sophisticated instruments tackled by highly experienced and qualified personnel. We have full-fledged separate locale for Chemical analysis, Instrumentation, Microbiology section, Sterility and Package testing.

The instruments are calibrated and validated periodically to check their performance so as to avoid any labor-intensive errors.

Written Standard Operating Procedures (SOPs) are maintained and followed for receipt, testing and storage of raw materials and packaging components, production and packagiang, in-process checks and cleaning, and release of finished product to the customer.

In addition there are procedures for ancillary processes such as stability testing process validation, controlling documents, laboratory processes,calibration protocols, etc.

Strong Quality Control…

stringent Quality Control and Assurance Process:

The procedure of Quality Control and Quality Assurance starts right from the phase of procurement of raw material to delivery of finished product.
Each raw material, packaging material and finished product goes through stringent quality checks. As part of the Quality Control and Assurance process, a Standard Operating Procedure is in place, which forms the guideline for the procedures to be followed for each activity that is performed in the plant and laboratories. The development process for any formulation ensures strict compliance with GMP.

PROCUREMENT > > Every raw/packaging material received at the manufacturing site is procured only from entrenched and approved manufacturers or suppliers. Approved vendors are judged by a vendor audit or by evaluating their yearly performance. Eventually ISO 9001 : 2008 certification will be availed in due course of time.

ANALYSIS > > Each raw/packaging material is sampled and analyzed by Q.C. before releasing for production. Additional tests like solubility, water content, chromatographic purity and particle size are done on ingredient to ensure utmost quality. Finished products are analyzed as per Pharmacopoeia and additional stringent in-house specifications.

PROCESS VALIDATION > > Quality Assurance personnel carry out process validation studies to judge the performance parameters.

WHO-GMP STATUS & FACILITY : -

ModHike’s pharma manufacturing plant has been conceived with a sight to set up a state of art facility, authenticating to International standards in line with WHO-GMP Guidelines besides, meeting the requirements for approval by MCA, UK and TGA, Australia.