HOLD TIME STUDY IN PHARMA

The storage of dispensed raw materials and packaging materials, intermediate products, bulk items, and final products must be done in accordance with good manufacturing principles (GMP). In the pharmaceutical industry, the hold time study in pharma refers to the time period that has been determined during which items (dispensed raw ingredients, intermediates, and bulk dosage forms awaiting final packaging) may be held under specific circumstances and still meet stated criteria.
As an example, for Oral tablets that are coated, the following stages may be considered:
– Binder preparation to granulation – consider the granules;
– Wet granulation to drying – consider the dried granules;
– Dried granules to lubrication/blending – consider the lubricated blend;
– Blend to Compression;
– Compression to Coating; – Coating solution to preparation – consider the coating solution;
– Coating to packing – consider the bulk coated tablets;
– Coating to packing in bulk;
– Packing of bulk to finished packed dosage form.

It is important to hold a representative sample of the batch of raw materials or finished goods for the specified hold time. By preserving the material in either the actual or simulated container used in production, the hold period for each category of material should be determined based on the study. Unless the pack is particularly big, in which case one that is equivalent (built of the same material and utilising the same closure system as the production packaging system) may be used, the containers in which hold-time samples are kept should be the same pack as is used in production. When reducing the container’s size is required to evaluate holding duration, this decision should be supported.

The hold time study in pharma should simulate worst-case scenarios in situations when the headspace of containers used for bulk storage in production and/or quarantine is crucial, such as when there is a risk of possible degradation due to oxidation. In these circumstances, the headspace to contents ratio in the test containers should be at least as high as what is typically attainable in ordinary production (especially taking into account part-filled containers). The environment for sample storage should be the same as the manufacturing stage/quarantine area. It is important to design and adhere to a sampling plan when collecting samples for testing at various intervals. Calculate the appropriate sample size depending on the batch size, the intervals, and the tests that will be performed.

As an illustration, for Oral tablets that are carpeted, the ensuing stages may be considered
– Binder medication to granulation – consider the grains;
– Wet granulation to drying – consider the dried grains;
– Dried grains to lubrication/ blending – consider the oiled mix;
– mix to Compression;
– Compression to Coating; – Coating result to medication – consider the coating result;
– Coating to quilting – consider the bulk carpeted tablets;
– Coating to packing in bulk;
– Quilting of bulk to finished packed lozenge form.

1. SOP for Hold Time Study
2. SOP for Handling of Hold time Samples
3. Raw Material Hold Time Study Protocol Cum Report
4. Product Hold Time Study Protocol Cum Report
5. Hold Time Study of Garments
6. Hold time study for Sterility testing articles
7. Validation Protocol for Hold Time Study of Cell Suspension
8. Hold Time Validation for Sterilized Media (Prepared Media Plates and Tubes)
9. SOP for Hold time Study of Products
10. Performance Qualification Protocol for Holding Vessel
11. Performance Qualification Report for Holding Vessel
12. Validation Protocol for Hold time Study of Dried Articles
13. SOP for Hold Time Study (2)
14. Hold Time Study Protocol Cum Report for Hardgel Capsules
15. Raw Material Hold Time Study Protocol cum Report
16. Hold Time Study Protocol for Gelatin Mass
17. Hold Time Study Protocol Cum Report for Oral Liquid
18. Hold Time Study Protocol cum Report for Ointments