Purpose
To provide guidelines for conducting the hold time study of intermediates.
Scope
This procedure is applicable for the hold time study of intermediates.
Responsibility
Head QA & Concern department Head.
Procedure
- Executive QA prepares the hold time study protocol having the following points :
- 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.)
- Protocol approval, containing prepared by (QA Personal), Checked by (Manager QC, Manager Manufacturing), & finally Approved by Manager- QA.
- 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
Where
AA stands for Company Name
XXX stands for 001, 002, and 003.
Abbreviation
Nil
Revision History
Nil
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