Pharmaceutical Testing

In pharmaceutical products, impurities are defined as substances that provide no therapeutic benefit, but do have the potential to cause adverse effects. Therefore, impurity levels need to be controlled such that pharmaceutical products are sufficiently safe to be administered to humans. Impurities impact the safety and development time of medicinal products, as well as the sales and marketing of drugs. According to ICH guidelines, impurities related to drug substances can be classified into three main categories: organic impurities, inorganic (elemental) impurities, and residual solvents.Within these categories, genotoxic impurities form a special case that poses a significant safety risk, even at low concentrations, because they may be mutagenic and are therefore potentially damaging to DNA. As a result they can lead to mutations or cause cancer. Doctors’ Analytical Laboratories Pharma Division is currently Indian FDA (Maharashtra) Approved and registered with US-FDA. The Lab has been successfully inspected by US-FDA. Projects completed have been submitted to various regulatory bodies on numerous occasion. Our Process are full compliance with cGMP norms and are regularly upgraded to meet new stipulation. The Infrastructure comprises of the state of art facility housed with most modern equipment’s including UPLC-MS/MS, ICP-MS with a near future plan in place for GCMSMS(Headspace), HPLC’s , GC to name a few.

Our current services at the pharma division include :

Method Development and Validation

  • Genotoxic Impurity [“Nitrosamine Impurities”] quantification studies by UPLC MSMS
  • Carryover Impurity Studies
  • Elemental Impurities by ICP MS as per ICH Q3D & USP 232
  • Extractable & Leechables as per FDA guidelines & PQRI suggestions
Pharmacopoieal Analysis
  • Elemental Impurities analysis as per USP chapter <232> and <233>
  • Elemental Impurities as per USP 2232 for dietary supplements

QUALITY POLICY

Doctors’ Analytical Laboratories Pvt. Ltd, (PHARMA DIVISION)
  • DALPL Stands committed to compliance to applicable regulations eg. USFDA, MHRA, WHO, Health Canada, etc. so as to ensure the quality of operations in its testing and research activities.
  • DALPL shall maintain a Management system as per the requirements of cGMP, FDA (Maharashtra), to generate scientifically valid data and results defined by the laboratory director or senior administrative management with staff participation.
  • DALPL shall maintain high quality standards by continuous improvements in all its operations through appropriate stakeholder trainings, rigorous reviews and participation of all employees.
  • DALPL’s personnel responsible for testing shall be trained for the quality documentation and for implementing the policies and procedures in their work.
  • DALPL shall provide services in accordance with applicable national and international standards.
  • DALPL shall ensure customer confidence by maintaining integrity and data confidentiality in its operations and by improving Quality systems continuously.
  • DALPL’s Senior Management is committed to continual improvement, meeting regulatory requirements and customer requirements, and providing a basis for the establishment and review of the quality objectives.
  • DALPL’s Quality practices are communicated within the organization, understood and adhered to by all employees.