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.
- Labeling and packing requirements as prescribed by Drugs & Cosmetic Act and or respective country labeling act.
- Amendments and notifications issued by regulatory authorities
- Pharmacopoeia changes
- Country specific regulatory requirements
- Manufacturing Location change
- Pack Size and pack style change
- Change as per marketing / Customer requirement
- Change in primary and secondary packaging
- Change as per machine requirements
- Change in design
Dear dushyant sir thanks for the informative reply.