Quality Assurance Systems (QA)

At Ind-Swift, we take utmost focus in adherence to the QA policies. Our policies direct our operation to constantly create an environment of quality and compliance in line with the best recognized global practices.


Quality is the mainstay of our competitiveness.


Quality Assurance, though an independent function, works as an interface between R&D and manufacturing strictly abiding with the standardized quality system, providing consistency, effectiveness and efficiency for all manufacturing activities of APIs across all our manufacturing locations.

Every component of our organization engages itself towards driving the quality philosophy of the organization and assuring that the global standards of cGMP are implemented in form and spirit at every level and during each process.

Our systems & policies bring effectiveness through periodic quality reviews, periodic audits, review of compliance to regulatory inspections and customer audits.

Focuses on review of failures, rejections, market complaints, deviations, non-compliances, product stability and various corrective & preventive actions planning.

Our endeavour is to constantly achieve “QUALITY EXCELLENCE”. 

Our Total Quality focus is based on following pillars

1

Establishing Quality Standards​

1

Establishing Quality Standards​

2

Training personnel​

2

Training personnel​

3

Developing processes to achieve set standards​

3

Developing processes to achieve set standards​

4

Close Monitoring​

4

Close Monitoring​

5

Consistency at every stage​

5

Consistency at every stage​

Our Global Regulatory Approvals

Year Country/Authorities Product
2004
Ministry of Health, Iran
Clarithromycin, Atorvastatin Calcium, Clarithromycin Granules
2006
Therapeutic Goods Administration (TGA), Australia
Clarithromycin
2007
United State Food & Drug Administration (USFDA), US
Clarithromycin
2007
National Institute of Pharmacy (NIP), Hungary
Anastrozole
2008
German Health Authority, Behorde fur Soziales, Familie, Gesundheit und Verbraucherschutz, Germany
Atorvastatin Calcium, Clopidogrel Besylate, Aripiprazole
2010
Korean Food & Drug Administration (KFDA), Korea
Risedronate Sodium, Ezetimibe
2010
Pharmaceutical and Medical Devices Agency (PMDA), Japan
Risedronate Sodium, Pioglitazone Hydrochloride
2011
Therapeutic Goods Administration (TGA), Australia
Clarithromycin, Donepezil Hydrochloride, Letrozole, Ropinirole Hydrochloride, Acamprosate Calcium, Aripiprazole, Pioglitazone Hydrochloride, Atorvastatin Calcium
2011
National Organization of Medicine (NOM), Greece
Clarithromycin, Clarithromycin Coated Granules
2011
German Health Authority, Behorde fur Gesundheit und Verbraucherschutz, Germany
Atorvastatin Calcium, Aripiprazole
Year Country/Authorities Product
2011
United State Food & Drug Administration (USFDA), US
Clarithromycin, Donepezil Hydrochloride, Acamprosate Calcium, Ropinirole Hydrochloride, Naratriptan Hydrochloride
2014
Anvisa, Brazil
Clarithromycin
2014
Cofepris, Mexico
Dutasteride, Quetiapine Fumarate, Atorvastatin Calcium, Aripiprazole, Clopidogrel Bisulphate, Fexofenadine Hydrochloride, Risedronate Sodium
2015
NOM, Greece
Clarithromycin Coated Granules
2015
United State Food & Drug Administration (USFDA), US
Acamprosate Calcium, Aripiprazole, Clarithromycin Extrapure, Donepezil Hydrochloride, Nateglinide, Risedronate Sodium, Temozolomide
2016
EDQM, France +ANSM, France
Clarithromycin (EDQM), Clopidogrel Hydrochloride (ANSM, France)
2017
Pharmaceutical and Medical Devices Agency (PMDA), Japan
Trityl Olmesartan Medoxomil (Intermediate)
2017
United State Food & Drug Administration (USFDA), US
For All Marketed APIs
2018
United State Food & Drug Administration (USFDA), US
For All Marketed APIs

Our regulatory process also covers:

  • Submission of product registration applications in the form of CTD-Dossiers, marketing applications, ANDA, NDA etc.
  • Response to queries or deficiencies from regulatory bodies / customers.
  • Inspections and inspection reports.
  • Post approval / marketing surveillance by regulatory bodies.
  • Submission of annual updates to regulatory bodies.

Quality Control Capacities (QC)

Our analytical laboratory is GMP compliant having latest available analytical technique at site. It is compliant with the highest quality standards required by regulatory bodies for the manufacturing and marketing of API products. We meet the regulatory expectation related to data integrity and control on computer system are very well established in the laboratory. Experts are handled the analytical activity and each individual are very well trained on the procedure.

Below is the list of major instruments we have, and are constantly upgrading our capabilities with each passing month.

Our Analytical Service Expertise 

  • Analytical method development, validation & optimization
  • Chromatographic analysis to identify the trace level of impurities (HPLC with UV, PDA, RI and GC with FID, ECD)
  • Quantification of genotoxic impurities, elemental impurities as per ICH Q3D
  • Spectroscopic analysis (UV, IR)
  • Physical and physicochemical analysis (pH, Wet analysis, Particle size)
  • Dissolution for coated granules
  • Characterization of polymorphs/pseudo polymorphs (XRPD)

Our Capacities of Stability Studies

  • Control on storage and management
  • Development and validation of stability indicating methods including dissolution testing
  • Stability Chamber with backup reach-in chambers
  • Comprehensive documentation as per GMP requirement

All ICH + specific conditions

  • Long-term stability studies
  • Short term, accelerated studies
  • Follow-up stabilities
  • Photo stability testing 
Temperature Humidity
25°C ± 2°C
60% RH ± 5% RH
30°C ± 2°C
65% RH ± 5% RH
30°C ± 2°C
75% RH ± 5% RH
40°C ± 2°C
75% RH ± 5% RH
5°C ± 3°C
No Humidity

Our Microbiology Capacities

  • Microbial limits tests
  • Microbial contaminant identification
  • Microbiological assessment of antibiotics
  • Environmental monitoring 
Instrument Model/Make
High Performance Liquid Chromatography
Thermo fisher (Dionex), Model: Ultimate 3000
High Performance Liquid Chromatography
Waters (Alliance), Model: e2695 separation module & 2489 UV/Vis
Ultra Performance Liquid Chromatography
Waters, Acquity
Gas Chromatography coupled with Head Space
Perkin Elmer, Model: Clarus with FID/ECD
Gas Chromatography coupled with Head Space
Agilent Technologies, Model: GC-7890
X-Ray Diffractometer (XRD)
PANalytical, Model: X’Pert Pro
Analytical Balance
Sartorius, Model: CP225D
Analytical Balance
Mettler, Model: XPE26, XSE105DU
Analytical Balance
Precissa, Model: EP225SM-DR
KF Titrator/Auto titrator
Metrohm, Model: 890 / 836 Titrando
Glassware Washer-Dryer
Lancer, 820 LX
Inductively coupled plasma mass spectroscopy (ICPMS)
Thermofischer, Model:iCAP RQ
Particle Size Analyzer with Wet & Dry accessories
Malvern, Model: MASTERSIZER 2000/ 3000
Air Jet Sieve Shaker
Retsch, AS200 Jet
Stability chamber
Thermolab
Dissolution Apparatus
Labindia
Cold Lab Chamber
Fiocchetti, Medika, LUX 1000
Inductively coupled plasma mass spectroscopy (ICPMS)
Thermofischer, Model:iCAP RQ
Atomic Absorption Spectrometer
Varian, AA240FS, Zeeman GTA-120
Microwave digestion system
Anton paar, Model: Multiwave pro
TOC Analyzer
Shimadzu, TOC-Vcph, Lcph
Laminar Air Flow
Klenzaids, 1500C-48-24-24
Garment Cubical
Ultra Clean Air Product
Steam Sterilizer
Indo German, VSDDSS-224
Go to Top