konsol logo

Scope of Work

GMP

Good Manufacturing Practice or GMP is a term that is recognized worldwide for the control and management of manufacturing and quality control of foods, pharmaceutical products, and medical Devices. GMPs are guidelines that outline certain aspects of production which would affect the quality of a product. Many countries have legislated that pharmaceutical, food and medical device companies must follow GMP procedures, and have created their own GMP guidelines which correspond with their legislation. When a company is setting up their quality program and manufacturing process, there may be many ways in which it can fulfil GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process. Basic principles of WHO GMP is similar to any established GMP requirement. These requirements are not for domestic use but for international trade. India is a major exporter of drugs & pharmaceuticals globally; therefore new applications are regularly made to the Drugs Controller in Delhi for certifications. The west zone of India leads in GMP certified units. We in KONSOL can advise & help in the following areas:

  • All matters pertaining to Good Manufacturing Practices (GMP) and clarifications on such matters.
  • Up-gradation and redesigning of existing plants with respect to their GMP and aligning them to Schedule M or WHO norms.
  • GMP designing of new/Greenfield projects and advising them on an ongoing basis during project implementation.
  • On-site training in GMP
Audit

Audits Certification and training play a major part in the pharmaceutical business and we are in a position to advice on:

  • Preparation of Dossiers,
  • Getting certification as per various regulatory norms,
  • Comprehensive training, validations including up gradation of facilities.
  • We can also carry out third party audits on behalf of clients and help in implementing quality systems.
End to End Solutions
  • We are in a position to provide a one stop solution to Pharmaceutical enterprises for all their needs in setting up a factory in terms of Project Management, Establishment of GMP & GLP, ISO Systems etc.
  • Help in applying for manufacturing licenses and in importing of drugs.
  • Price fixation as per latest DPCO.
  • Engagement as advisor/consultant on most pharma related topics.