when performed HOLD TIME STUDYS…?
on every critical stage to determine safe hold time
which guidelines is available for HTS…?
Hold time studies are mostly conducted for in process materials. Let me tell you a brief example.
You have a blend X ready for compression which is stored in a bulk container. But you have lot many other batches to be compressed using same machine and you won’t be able compress blend X for another 30 days. How can you assure the content uniformity of your blend which is stored in a bulk container after 30 day’s. For this purpose initially during development or during process validation the blends will be kept on hold for certain period and it shall be sampled on predetermined time points (15, 30 & 45 days) and shall be analyzed for assay and blend uniformity.
Some other situations where you can perform hold time studies is
- For coating solutions
- For granulation fluid
Hope you got some information for what you are looking for. I’ll try to post any guideline if available at the earliest.
Excellent Information Sir