Pharmacy Courses

Hold Time Study Protocol Template


As per WHO, a hold time study protocol should generally include the following: 

  • a title; 
  • reference number; 
  • version; 
  • date;
  • objective; 
  • scope; 
  • responsibility; 
  • procedure; 
  • description of the material or product; 
  • sample quantities; 
  • sampling method and criteria;
  • acceptance limits; 
  • frequency of sampling; 
  • sampling locations; 
  • pooling of samples;
  • storage conditions; 
  • type of container; 
  • methods of analysis;  
  • conclusion;
  • signatures; and dates. 

A Sample of Hold Time Study Protocol is Given Below:

1. Objective & Scope

Hold time study data shall give the assurance the maximum allowable hold times for bulk and inprocess drug products. Generally, one lot can be used for validating hold times if any inconsistency results were observed then another two lots can be used for this study.

2. Responsibilities


  • To prepare protocol and report.
  • Sampling as per the approved protocol.
  • Conclude the result.

Quality Control:

  • Review the protocol and report.
  • To analysis the hold time study samples as per the approved protocol and report the results.

  • Review the protocol.
  • Assist during hold time study sampling.

Quality Assurance:
  • Approve the hold time study protocol and report.

3. Hold Time Consideration

  • Dispensed Raw materials (if needed)
  • Granulation Solutions & Coating Solutions
  • Powder Blends & Granules
  • Core Tablets & Capsules
  • Oral Liquids and Semi-Solids (Syrups, Suspensions, Creams and Ointments)

4. Hold Time Stages for Coated Tablets

Hold Time Stages for Different Dosage Form

5. Tests to be Considered

For core tablets:
For coated tablets:

Atypical Testing Parameters and Acceptance Criterial for Hold Time Study

6. Conclusion

The conclusion should state whether the outcome of the activity was successful or not.

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