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Undoubtedly, the Quality Control laboratory is the most essential component of the drug industry the trust and consistency of a laboratory’s results in an achievement and it is developed by better attitude and environment that are based on proper management of human resources, ongoing control (validation of materials, instrument and techniques).

Quality control and Quality assurance department is providing high quality analytical testing of the pharmaceutical products to ensure the best for our customers/clients & consumers.

General profile of our Quality control laboratory

A laboratory can only be for analyzing Samples or an institution for investigation, creativity, development, training and education in addition to a trusted testing site. Safety, potency and efficacy are the three aspects of quality drugs.

Our quality control laboratory is composed of several divisions/sections for carrying various test requiring different analytical techniques.

Our various sections include:
 

Listed below are some of our routine jobs are:
 

Analytical Chemistry Environmental Monitoring
Method Development and Validation Microbiological Testing
Stability Studies Water System Validation
Audit, review and quality control
Many of the tests we perform are specific which are not listed above, particularly in the area of analytical chemistry.
Analytical Chemistry
The professional expertise and qualified team members of QC & QA department take charge of analytical control for raw materials, API’s, finished products, packaging material.
Our analytical are selected among graduate and master in pharmacy, analytical chemistry, biochemistry and microbiology as required for specify task.
Well-equipped state-of-the art laboratories offer comprehensive testing services according to the different official pharmacopoeia (e.g. USA, BP, IP, JP.) for customer specifications
   
Chemical and Physico-Chemical testing:-
Assays and chemical tests (e.g. HPCL, UV/Vis spectrophotometer etc.).
Identification of active ingredients and impurities.
Physical and physico-chemical determinations ?(e.g. pH, Viscosity, Melting point, optical rotation, osmolality and osmolarity, flash point, loss on drying , loss on ignition etc.).
Limit test (e.g. heavy metals, acetyl groups alkaloids, primary aromatic compounds, arsenic compounds etc).
Residual solvents (volatile organic compounds [VOC] ,organic volatile impurities[OVI]).
Pharmaceutical technical procedures (e.g. disintegration, dissolution, hardness, friability).
Sampling and analyses of water for pharmaceutical purpose and controlled process environment (e.g. TOC, conductivity)
Environmental Monitoring
In addition to acceptance tests for the installation of clean rooms in production facilities, routine monitoring also plays a very important role. These measurements help monitor clean rooms as well as production facilities during operation.
Sartkah Biotech enjoys a broad range of monitoring service for clean rooms and can also provide you with customized hygienic-monitoring programs that suit your need.
Routine jobs carried out by quality department are
Checking personal hygiene, determination of microbiological exposure on the cloth and hands of production personnel.
Testing the effectiveness of cleaning and disinfection measure during operation at the end of production.
Microbiological tests on individual process media (air, water, technical gases).
Determination of bacterial count in the air under all operating conditions.
Particle measurement
Determination of TOC (total organic carbon)

Testing surfaces, consumables and primary packaging.

Method Development and Validation
Validation activity is a journey and not a destination through out the lifecycle of a product, process, equipment and facility. Validations are carried out as per defined procedure for processes, new formulas, changes to the existing procedures. Re-validation are carried out as per schedule ensure that the processes are achieving the intended use.
Our quality development departments have extensive knowledge and expertise in developing and validation methods for raw materials, API’s, finished produces cleaning validation.
Quality development department offers development and documentation of analytical protocols and reports for proprietary and non-proprietary test methods and manufacturing processes in compliance with the notes for Guidance “Validation of analytical procedure, Definitions and terminology” and “validation of analytical procedures, Methodology” by the WHO and GMP guidelines.
Method Development Services includes:
 
Identification Assay testing Testing for impurities
Stability indicating methods Humidity / Temperature PH values
Light stressing Microbial testing  
Method Validation includes:
 
Accuracy Precision Repeatability
Intermediate precision Reproducibility Specificity
Detection Limit Quantitation Limit Linearity
Range Robustness System suitability test
Microbiological Testing
 

Our Microbiologists are versed in their field and provide us the best required services.

  Our facilities meet the demanding cleans requirements of microbiological testing. Separate rooms are assigned for antibiotic and vitamins analysis. Our area for sterility testing should be under positive pressure with satisfactory locking system.
Biological and Microbiological services include:
 
Microbial limits tests for non-sterile products Sterility testing
Antibiotic and vitamins analysis Microbial contaminant identification
Preservatives testing and microbial challenges Microbiological assessment of antibiotics
Bacterial endotoxin testing Sampling and analyses of water for pharmaceutical microbiology
Chemical disinfectant testing and cleaning studies
Stability Studies
Our quality control department periocally evaluates the quality and stability of finished pharmaceutical product. Form study design to storage, monitoring, analytical testing and documentation, quality control department provide us the stability testing services according to the guidelines of fully GMP-GLP complaint laboratory environment.
Stability Studies testing includes:
Complete description of drugs involved in the study
Complete testing protocol / parameter and method describing all test potency, purity, and physical characteristics with documented evidence that these protocols will indicate stability.
Support in designing studies for real time, stress test and photostability studies
Development and validation of “stability indicating methods”
Examination of stability-relevant parameters
Storage and management of the stability samples
Interim reports for every testing period
Comprehensive final report
 
Water System Validation
 

Purified water is a key component in the manufacturing of virtually all pharmaceutical products. Water purification systems must be validated to ensure that the specified quality of water is consistently produced. Quality development department provide us testing services for validation of pharmaceutical water systems.

Sample for microbiological testing will be put on the test the day that the samples are received.

All water purification systems must be monitored regularly to verify the quality of the water produced. Water purification systems can potentially harbor high level of bacteria. Bacteria or chemical purity problems with water can compromise the quality of finished products.
Water monographs performed according to IP/BP/USP:
 
TOC
Conductivity
Bacterial Endotoxins (LAL)
Particulate Matter
Total Microbial Count
Coliform
 

Our Quality development department facility is a multi-purpose facility having state of the art analytical equipments, systems and documentation. The qualified and skilled scientific pool maintains high quality and regulatory standards as per current Good Manufacturing Practice.
   
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