(a) List the key differences between a ‘Do and tell’ variation; a ‘Tell, wait an

(a) List the key differences between a ‘Do and tell’ variation; a ‘Tell, wait and do’
variation, and a and ‘Major’ variation. State the Type numbers for eachould you
recommend for a change in immediate packaging of the finished product where
this change is to a less protective pack, and there are associated changes in
storage conditions and/or reduction in shelf life.
Maximum 600 words, (50 % of the marks)
a) Review the outcome of the stability testing data provided by comparing the
performance of the tablets in existing packaging to tablets stored in the
proposed revised packaging, with reference to the approved shelf-life
Specification (provided).
b) Based on your consideration of the stability data above, provide a regulatory
recommendation on whether the varied product (packed in a polypropylene
bottle) will be suitable for marketing in Europe. Do you recommend any
change to the shelf life or storage conditions, in order to continue marketing in
Europe in the proposed polypropylene bottle?

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