Hold time study of Dispensed Raw Material and EHG Capsule

Quality Assurance
1

Please suggest any scientific base rationale and approach to perform HTS.

2

I don’t think it required to validate the dispensed raw material because these are stored in the same environmental conditions as the raw material is stored.
I request other members to share their thoughts.

3

Recently we have received a call from one of the reputed agency to show data as we have 45 days timeline for usage of dispensed RM/API/EHG Capsules

4

You are right Ankur sir but few customer auditor shall ask such data during audit. So, it’s better to have such data IH available.
Being a good manufacture we should gather scientific data through few protocol base study to evaluate the hold time study of following.
1. Raw material (category wise)
2. Packaging material (Criticality wise)
3. Intermediate products
4. Bulk products

“Manufacturers should gather scientific and justifiable data to demonstrate that the dispensed raw materials and packaging materials, intermediate and bulk products” as stated in WHO guideline.

Example-1
if we dispense the packaging material i.e. silica gel (barrer form / pouch form) , its tednecy to gain mositure from atmosphere even if we store in proper environmental condition
Note: We dispense materail from intact pack for routine usage.
( Example share for better understanding purpose)

5

Yes, you are right @dushyant3044 some customer auditors are more strict than regulatory auditors :slightly_smiling_face:

6

we have given 24 hrs hold time for dispensed raw materials, because after purging nitrogen in poly ethylene bag contains raw material, nitrogen will slowly reduces its quality…

7

Have you any validation data for the same?

8

according to nitrogen content present in poly bag

9

Dear Sir,
We have Dispensed Amoxicillin Batch Before 7 day Prior to Manufacturing.
Can we Do Hold time Study for 7 days only or 60 days like Blend.

10

It’s is not necessary to do the hold time study for specific time period, you have to show the evidence study, you can do the hold time study as per your convient like it may be 7 day, 15 day or so either 60 day based on study we have to prove that it have no impact on product quality.

Instead of performing hold time study for all dispensed material you can do bracketing for API and excipients which leads to grow microorganisms can select for hold time study

11

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