Latest Hold Time Study Guidance

Hold Time Study Guidance is essential for Pharmaceutical Industry to meet the cGMP requirements. Hence the Guidance is provided at PharmaeliX. Here in the Holding study of Products described here. This is for your information only (Guidance).

Hold Time Study Introduction

Hold Time Study in Pharma is a process used to determine the length of time that a product can be stored or held under specific conditions before it begins to degrade in quality. This study is critical in the pharmaceutical industry as it helps to ensure that the drugs are safe and effective for use and meet regulatory requirements.

The steps of Hold Time Study in Pharma

The steps involved in conducting a Hold Time Study in Pharma are as follows:

1. Establishing the study protocol: The protocol outlines the objectives, study design, sample size, and test methods to be used during the study.
2. Sampling: The sample of the drug product is collected and stored under controlled conditions for a specified time period.
3. Testing: The samples are tested at various intervals to determine the stability and quality of the drug product. The tests may include physical, chemical, and microbiological tests.
4. Data analysis: The results of the tests are analyzed to determine if the product is still within the specified stability limits and if it is safe for use.
5. Reporting: The results of the study are documented in a report, including a summary of the findings and any recommendations for changes to the storage conditions.
6. Validation: The study is validated by regulatory agencies to ensure that the results are accurate and that the product meets the required standards.

Hold Time Studies in Pharma are crucial to ensure the safety and efficacy of drugs and to comply with regulatory requirements. It helps to ensure that the drugs remain stable and effective during storage, transportation, and use.

The Hold Time Study shall conduct in a minimum of three batches.

The Hold Time Study Protocol for new products shall prepare by Process Development Personnel for existing products, reviewed by Production Personnel & approved by the in-charge QA or designee.

The sampling plan & analytical method for the hold time study shall be as per the respective hold time protocol.

Hold Time Study Protocol

The protocol shall be prepared with the below numbering system.

• The numbering system consists of “UXHTP/Y/Z-00”.
• “U” stands for the unit where “F” denotes the “Formulation”, and “A” denotes “API”.
• The “X” character denotes unit code (1/2/3).
• Characters “HTP” denote Hold Time Protocol.
• The “Y” denotes the product code.
• The “Z” denotes the Serial number of the Protocol (01/02/03 and “00” is the version number).

Report Numbering System

• The numbering system consists of “UXHTR/Y/Z-00”.
• The characters “HTR” denote Hold Time Report.

Hold Time Study Procedure

Approved Protocol shall submit to Documentation Cell & documentation cell shall issue the copies before initiation of the study.

The sample shall collect as per the respective protocol.

Samples shall label as “HOLD TIME SAMPLE FOR ANALYSIS”.

Samples are to be collected in containers used for regular storage of intermediate products & to be stored Quarantine area.

The storage area shall monitor for temperature & relative humidity during the hold time study.

The samples collected are to evaluate as per the protocol at regular intervals.

The production person to raise the request & QA to collect the request & sample as per the plan & forward it to QC for analysis.

QC to store samples at 5°C to 15°C & analyze the final sample first. If the final sample passes remaining sample need not analyze. But if the final sample does not meet the specification, then the samples shall remove from the freezer & analyze in reverse order.

 On receipt of the Certificate of Analysis, QA shall forward the same to TTG or Process development. Process Development or TTG personnel shall prepare the Hold Time Report based on the result & make conclusions & recommendations for the product.

Holding Time Study Conclusion

On evaluation & recommendations the hold Time Study report, backup data, COA & hold Time study Protocol shall be forwarded to production & QA for approval.

After approval, all records are to be retained with QA.

Leftover qty to be destroyed.

Based on Hold Time Study Data, hold Time for the intermediate to be established.

For products where Hold Time is not defined, the following is to be followed.

Read never before articles only at PharmaeliX – Corrective and Preventive Actions Guidance

Reference IndoJobs, FDA, WHO

The test is to be conducted as laid down in the process & finished product specification.