Quality Control

Quality is a way of life in ModHike

Quality Control

Quality Control Laboratories:

Our Quality Control laboratories are well equipped with sophisticated instruments tackled by highly experienced and qualified personnel. We have a full-fledged separate locale for Chemical analysis, Instrumentation, Microbiology section, Sterility, and Others.
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 packaging, in-process checks and cleaning, and release of the 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.

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.

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.

INTERNATIONALY ACCREDITED

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.

Quality control

Quality, to deliver the promise of good health is the one, every employee in Modhike lives by.

Modhike Adhere to
– Good Manufacturing Practices (GMP)
– Good Clinical Practices ( GCP)
– Good Laboratory Practices(GLP)

Our stringent quality norms are endorsed through the wide acceptance of our brands. However, to ensure quality we take precautions at all steps

Step – 1: Selection of RM which is of the best grade and confirms specifications strictly laid down by law and QC norms. Vendor selection is made to ensure the best goes into the finished formulations

Step – 2: Product stability evaluation is an ongoing process and as per ICH guidelines

Step – 3: Every batch is checked at multiple levels from location to warehouse and lab analysis is done of control samples

We have capabilities in both hardware and software in developing and standardizing analytical techniques for all our products. Our products pass stringent tests backed by following quality systems that ensure compliance with international standards.

 
Classical analysis by Physio-chemical methods
Instrumental analysis using sophisticated instruments like HPLC, GC, FTIR, Particle counter, etc.
Stability Testing as per ICH guidelines. For that, we are provided with walk-in stability chambers.
Microanalysis like MLT, BET & Sterility testing.

Our QC & QA Facility