JAGSONPAL PHARMACEUTICALS LIMITED

Plot No. 14-16, 55-57, Sector-5, IIE, Pantnagar, Dist. Udham Singh Nagar (Rudrapur) -263153, Uttrakhand-India
SOP Reference No.: JQA-SOP-001
Title: Standard Operating Procedure for conducting SOP No.: JQA-SOP-023
the hold time study Copy No.:
Department: Quality Assurance Revision No.: 01 Page No. : 1 of 3
Issue Date : Effective Date: Review Date:
Prepared By Checked By Approved By
Signature:
Date:
F

Purpose
To provide guidelines for conducting the hold time study of intermediates.
2. Scope
This procedure is applicable for hold time study of intermediates
3. Responsibility
Head QA & Concern department Head
4. General conditions
Not Applicable
5. Precautions
Not applicable
6. Procedure
6.1 Executive QA prepares the hold time study protocol having following points :
6.1.1 A cover page having heading “Protocol for Hold Time Study for
Intermediates”, Product name, Batch Number & Stage (i.e. Blend, core tablet,
coating solution, coated tablets etc.)
6.1.2 Protocol approval, containing prepared by (QA Personal), Checked by
(Manager QC, Manager Manufacturing), & finally Approved by Manager- QA.
6.1.3 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.
6.2 All activities are performed as per Hold Time Study protocol.
6.3 QA personal prepares the master copy of the protocol by putting “MASTER COPY” stamp &
sign/date on the right hand side of each page. & QA person issues the protocol with batch
record, after photocopy of the master protocol by putting issued by stamp on the left hand
side of the protocol on each pages. Manufacturing person receives the protocol & record is
maintained for the same in the register.
6.4 After analysis, QA person writes the results in the Report (attached format in the Protocol) &
Manager QA checks the Result.
6.5 Final report is approved by Manager QA.
6.6 Three consecutive batches are taken for the study.
6.7 Hold time study protocol is numbered as JQA–HTS–XXX
Where XXX stands for 001, 002, and 003….

JQA-001/01-00
JAGSONPAL PHARMACEUTICALS LIMITED
Plot No. 14-16, 55-57, Sector-5, IIE, Pantnagar, Dist. Udham Singh Nagar (Rudrapur) -263153, Uttrakhand-India
SOP Reference No.: JQA-SOP-001
Title: Standard Operating Procedure for conducting SOP No.: JQA-SOP-023
the hold time study Copy No.:
Department: Quality Assurance Revision No.: 01 Page No. : 2 of 3
Issue Date : Effective Date: Review Date:
Prepared By Checked By Approved By
Signature:
Date:
7. Acceptance criteria
As and when required
8. Frequency
Not Applicable

9. Distribution
Distribution Copy No.
Head Quality Assurance : 01
Display Copy (retain by QA) : 02
Plant Head : 03
Head Manufacturing : 04
Head QC : 05

10. Definition/Abbreviation
Not applicable

11. Format for recording

Not applicable

JQA-001/01-00
 JAGSONPAL PHARMACEUTICALS LIMITED
Plot No. 14-16, 55-57, Sector-5, IIE, Pantnagar, Dist. Udham Singh Nagar (Rudrapur) -263153, Uttrakhand-India
SOP Reference No.: JQA-SOP-001
Title: Standard Operating Procedure for conducting SOP No.: JQA-SOP-023
the hold time study Copy No.:
Department: Quality Assurance Revision No.: 01 Page No. : 3 of 3
Issue Date : Effective Date: Review Date:
Prepared By Checked By Approved By
Signature:
Date:
12. Revision History
Sr. No. Date of revision Revision no. Reason for revision
(Effective Date)
1.0 01-05-2009 00 first edition – not applicable
2.0 01  SOP prepared on new format as SOP for SOP
revised.
 All text revised
 Plant Head incorporated into distribution list.

JQA-001/01-00