a. Analytical
b. A professional and Comprehensive cGMP
Training Program
c. Auditing and Regulatory Services
a. Analytical:
Our analytical staff develops the method for new drug or drug product analysis and also does the validation of newly developed method. They also perform stability and release testing of the finished pharmaceutical products and raw material, cosmetic and nutritional product by strictly following the cGMP, ICH and USFDA guideline. We are maintaining the quality unit by doing accurate analysis and storing the all scientific data safely.
- Method development and Validation
Our analytical staff has enough experience and talent to develop the new method and also validate the method for pharmaceutical, cosmetic and nutritional product. We also provide the service of Method transfer.
- Process Validation and Cleaning Validation
ITPL also performs the process and cleaning validations. Process validation provides the view of quality and uniformity of drug between batch to batch and also within the batch from starting point to end point of manufacturing.
Cleaning validation is process of the residue free assurance to predetermined levels of acceptability. The Implementation of cleaning validation process is very essential for safety purpose.
- Testing of Raw material and Finished product
Raw material and finished product testing for quality batch release is performed by following the USP, EP, BP, JP, FCC, AOAC and Client method
- Instrument analysis Capability
Quantitative Assay Analysis
High Performance Liquid Chromatography with various kinds of Detectors such as UV-Visible, Fluorescence, Photo Diode Array, Refractive Index and Evaporating Light Scattering Detector (ELSD)
Gas Chromatography with various detectors like Flame Ionization detector (FID), and Thermal Conductivity detector (TCD)
UV-Visible spectroscopy
Structure identification
High Performance Liquid Chromatography coupled Triple Quadruple Mass Spectrometry (LC/MS/MS)
Gas chromatography coupled with Mass Spectrometry (GC/MS)
Infrared Spectroscopy (FT-IR)
Residual solvent analysis
Gas chromatography coupled with Head space (GC -HS)Metal analysis
Atomic Absorbance (AA), Graphite Furnace Atomic Absorbance and Flame Photometer
Dissolution Testing
USP Dissolution Apparatus I (Basket) and II (Paddle)
Wet Chemistry Analysis
Karl –Fischer for Water determination, Refracto meter, Polarimeter, Viscometer, Fluorimeter, pH meter, Melting range instrument, TLC and Moisture Detremination Balance.
Stability Testing
We have Experience in all types of stability studies from bulk drug substances to pilot formulation, clinical batches and finished market product. We provide the assay testing, related compound testing, impurities testing and degradation product testing in stability study.
Pharmaceutical Consulting Services to Pharmaceutical & API Manufacturers
a. A professional and Comprehensive cGMP Training Program:
With our cGMP compliance experts and at your facility, we can conduct and carry on a specific cGMP training program for all departments within the manufacturing facility on a biannual basis:
- Good Laboratory Practice (GLP): Good Analytical Skills and Good Laboratory Documentation Practices, Laboratory Safety Skills, Data integrity and HPLC system security
- cGMP for Production: cGMP of Personal Hygiene, Contamination sources and controls. Good Documentation Practice, cGMP under controlled conditions, cGMP for Tableting and Encapsulation.
- cGMP for Packaging and Labeling: the Packaging process, Primary and secondary packaging, Reconciliation Process ,Good Documentation Practice
- cGMP for Sterile: cGMP under controlled conditions, cGMP for Microbiology, Good Behavior in Clean Rooms, Gowning procedure for clean rooms
- cGMP for Logistics: Receiving, Quarantine, Rejection, Goods on Hold, FIFO & FEFO, Labeling, Sampling and the shipping & distribution process cGMP OF Personal Hygiene, Good Documentation Practice
- cGMP for Engineering and Maintenance: Calibration, Validation, Change control, Tooling, Assembly and disassembly, cGMP of Personal Hygiene, Good Documentation Practice
- cGMP for Validation: Cleaning Validation, Process Validation, CSV computer System Validation Analytical Method Validations, and Equipments Qualifications
- cGMP Trends Training: -Manufacturing Controls,-Packaging Controls,-Laboratory Controls and API Controls
- CAPA System Training: non-conformities, OOS, deviations and Good Investigation Practices.
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cGMP for API: Manufacturing Controls for Intermediate and final API phase.
b. cGMP Auditing and Regulatory Services
o On behalf of our clients we conduct cGMP -quality system inspection for the manufacturers of active pharmaceutical ingredients (API) or excipients by our worldwide leading experts that have covered more than 150 suppliers within India, China, Europe, Japan, Canada, Mexico and USA
o Our regulatory and technical affairs are at your disposal to help your facility or supplier in the submission process. o Registration files preparation for US FDA region. o Common Technical Document (CTD and eCTD) files preparation for EU and US markets. o Regulatory issues assistance and follow up with regulatory authorities and principals.
o current Good Manufacturing Practices (cGMP). o Good Documentation Practices (GDP)./span> o Good Laboratory Practices (GLP). o Good Clinical Practices
o Qualification protocols preparation and execution for facility, utilities, instruments and equipments in drug manufacturing facilities and drug stores. o Validation protocols preparation and execution which include process validation, cleaning validation and analytical method validation. o Site master file and validation master plan preparation. o Calibration/preventive maintenance protocols and programs preparation.
o This will include a comprehensive compliance gap assessment reports and generation of action and follow up plans, to assure successful regulatory inspections.
o Quality Assurance o Production o Regulatory Affairs o Quality Control o Warehouses o Engineering / Utilities o Research & Development(R&D)
o Pre-formulation studies. o Formulation studies. o Stability system programs. o Analytical methods development and validation. |
| o Trouble shooting in production department. |
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