SOP for Hold Time Study for Intermediates

To provide guidelines for conducting the hold time study of intermediates.

This procedure is applicable for the hold time study of intermediates.

Head QA & Concern department Head.

  • Executive QA prepares the hold time study protocol having the following points :
  1. A cover page having the heading “Protocol for Hold Time Study for Intermediates”, Product name, Batch Number & Stage (i.e. Blend, core tablet, coating solution, coated tablets etc.)
  2. Protocol approval, containing prepared by (QA Personal), Checked by (Manager QC, Manager Manufacturing), & finally Approved by Manager- QA.
  3. Contents, Objective, Scope, Responsibility, Execution of Plan, Methodology, Establishment, Hold time study validation Procedure, Evaluation of Results, Conclusion, Report approval & acceptance criteria, of the protocol.
  • All activities are performed as per the Hold Time Study protocol.
  • QA personnel prepares the master copy of the protocol by putting the “MASTER COPY” stamp & sign/date on the right-hand side of each page. & QA person issues the protocol with the batch record, after photocopy of the master protocol by putting the issued by the stamp on the left-hand side of the protocol on each page. The manufacturing person receives the protocol & the record is maintained for the same in the register.
  • After analysis, the QA person writes the results in the Report (attached format in the Protocol) & the Manager QA checks the Result.
  • Final report is approved by Manager QA.
  • Three consecutive batches are taken for the study.
  • Hold time study protocol is numbered as AAQA–HTS–XXX
AA stands for Company Name
XXX stands for 001, 002, and 003.


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