Supplier / Vendor Approval

  • TEPL encourages stringent compliance of cGMP regulations for its pharmaceutical suppliers. Approvals from esteemed regulatory agencies like USFDA, MHRA – UK, TGA, EU and other stringent agencies to vendor’s manufacturing facility is acceptable to TEPL’s QA and a visit to such facility is not necessary.
  • Facilities that are approved by PICs authorities are also acceptable to TEPLs’ QA and a visit to such facilities is not necessary.
  • Manufacturing facilities devoid of SRA or PICs approval are subjected to audit by TEPLs’ QA team. After successful audit the facility is approved for certain period with intermittent visits if found necessary.
  • For vendors supplying medical supplies TEPL follows CE/ISO certifications from Internationally recognized agencies as quality indicators. Suppliers having such certifications are approved after verification of authenticity of documents and a visit to such facilities is not necessary.

Supply Chain Activities

  • TEPL also monitor its supply chain activities from consigner’s facility tillfinal destination.
  • Mechanism to ensure efficient cargo storage, handling and transportation is worked out with warehouse, freight forwarding cos and Importers.
  • Any deviations or non-compliance is reported and measures to fulfil the gaps are immediately implemented.

Product Approval

  • TEPL’s QA approves the products after thoroughly reviewing the technical data and administrative documents shared by the supplier in form of Dossier.
  • Products that are WHO prequalified or SRA approved do not require a complete product approval procedure by TEPL.
  • For these items, we perform a number of checks to verify that the supplied products comply with the SRA or WHO PQ specifications.

Product Registration

  • TEPL has a dedicated team of regulatory affairs professionals based in Mumbai. Their expertise allows them to prepare country-specific dossiers for TEPL products.
  • Once the registration process is underway, the regulatory specialists monitor progress until the product receives marketing authorisation from the destination country. The team also provides support for post-marketing changes and administrative issues related to registration.
  • In recent years, TEPL has seen an increasing requirement for the registration of imported medicines. Sometimes this is driven by the destination country, when the National Drug Regulating Authority (NDRA) establishes specific registration requirements for pharmaceutical products and their packaging. TEPL is able to work with customers and donors to meet their various standards.

Batch Control

  • Each product that is manufactured goes through a thorough quality check before release. It is being held to an extensive quality control checklist, to make sure it is compliant with its specifications.
  • If any irregularity will be noticed, we will not release the product. This way we can assure that the specifications of the product comply with the actual product itself.

Batch Analysis

  • After we have assured the quality of our pharmaceutical products at the manufacturer.
  • we also conduct batch analysis of the products after we have received them to make sure they still comply with the specifications.