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
Validation:
- 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.
Production:
- 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.
Read also: Hold Time Study in Pharmaceutical Industry
