I think the biggest challenge is consistent implementation. Strong standards are important, but proper training, communication, and accountability are equally necessary to maintain quality at every stage.
Yes, it’s true, overall responsibility is not only on QA or QC. Apart from internal quality checks , there are SOPs also I.e. standard operating procedures. We need to implement SOPs at every step from API to Production and packaging as well. Also to conduct external audits are equally important to maintain law and order compliance.
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