PIH » Quality Assurance Quality Assurance – PIH

Quality Assurance

Since the drugs procured are meant for treatment of precious human life, it is our endeavor to ensure that only quality drugs are procured and supplied. Quality Assurance goes together with Quality Control and it is the onus of the bidder to ensure not only proper quality control but also total quality assurance.

  1. Product Quality: The supplier if in need, should be in a position to produce the certificates of analysis for the supplied drugs from an Accredited Laboratory/Central Drug Testing in respect of each batch supplied. This test report or the QC approval will not be deemed as a proof of stability of the product during shelf life. It is the onus of the supplier under the Drugs and Cosmetics Act/FDA or respective countries Accreditations and Rules to produce and supply drugs of standard quality and various measures are prescribed in the law to achieve the object. Supplies devoid such reports when needed, will not be taken into stock and payments will not be made. Suppliers will be required to take back the supplies and will be deemed as defaulters.

  2. Product Packaging & Storage: The packaging drugs used for primary and secondary packaging shall be of such nature that the quality of the drug contained is preserved throughout its life period. The storage requirements stated on the labels shall be in accordance with the provisions of the Drugs and Cosmetics Rules only and prescribing cool or cold storage for drugs in respect of which no such stipulation is made in the law will not be acceptable. The suppliers shall be solely responsible for ensuring the quality of the item during transportation and shelf-life.

  3. Inspections of manufacturing units of bidders prior to acceptance of bid or at any stage before or after award of contract will be at the discretion of PIH. The cost of travel and logistics can be mutually discussed on case to case basis.

  4. Reassurance:PIH would be testing the drugs and other materials at random at different stages, at discretion, and the supplier will have the obligation to pay the cost of the goods found to be defective and the bidder will also be liable for disqualification from the tenders of PIH. The cost of tests should be borne by the Supplier. There will be a prior intimation to the Supplier regarding the details of the test and analysis. Where any drug is found to be Not of standard quality or misbranded or adulterated or spurious or otherwise contravenes, the payments for the entire supply of the batch(s) concerned will be withheld or recovered.