Artwork approval requirement

Artwork approval is necessary when technology is transferred in case of new products.Is artwork approval required in case of existing products also?

Yes , Artwork approval is necessary for new product manufacturing& packaging process.

Prior to any new product manufacturing& packaging plan or existing product manufacturing & packaging approved artwork is key component.

When ever existing product labeling change , artwork approval is necessary for existing product manufacturing& packaging process.

Below mention are rational for change in approved artwork.

  1. Labeling and packing requirements as prescribed by Drugs & Cosmetic Act and or respective country labeling act.
  2. Amendments and notifications issued by regulatory authorities
  3. Pharmacopoeia changes
  4. Country specific regulatory requirements
  5. Manufacturing Location change
  6. Pack Size and pack style change
  7. Change as per marketing / Customer requirement
  8. Change in primary and secondary packaging
  9. Change as per machine requirements
  10. Change in design

Dear dushyant sir thanks for the informative reply.