DAXIN PHARMACEUTICALS PVT. LTD.

BADDI

Report No.: CLEANING VALIDATION Reference Protocol No.:

DPPL/CVR/001-00 REPORT DPPL/CVP/001-00
Revision No.: 00
Supersede: Nil Effective Date:
Product Name : Ofloxacin Tablets IP 200 mg Page 1 of 12

CLEANING VALIDATION
REPORT FOR WORST CASE
PRODUCT
OFLOXACIN TABLETS IP 200 MG
 DAXIN PHARMACEUTICALS PVT. LTD.
BADDI

Report No.: CLEANING VALIDATION Reference Protocol No.:

DPPL/CVR/001-00 REPORT DPPL/CVP/001-00
Revision No.: 00
Supersede: Nil Effective Date:
Product Name : Ofloxacin Tablets IP 200 mg Page 2 of 12

Sr. No. Contents Page No.

1.0 Objective 4

2.0 Scope 4

3.0 Responsibility, Validation Team & Committee 5

4.0 List and Training Record of personnel involved 7

5.0 Overview 8

6.0 Product and Batch Details 8

7.0 Acceptance Limit 9

8.0 Results and Observations 9

9.0 Deviation 10

10.0 Summary 10

11.0 Conclusion 10

12.0 Cleaning Validation Report Post Approval 11

13.0 Abbreviation 12

14.0 Annexures 12
 DAXIN PHARMACEUTICALS PVT. LTD.
BADDI

Report No.: CLEANING VALIDATION Reference Protocol No.:

DPPL/CVR/001-00 REPORT DPPL/CVP/001-00
Revision No.: 00
Supersede: Nil Effective Date:
Product Name : Ofloxacin Tablets IP 200 mg Page 3 of 12

REPORT APPROVAL

This report provides documentary evidence that the cleaning validation activity on worst case
product Ofloxacin Tablets IP 200 mg has been accomplished as per cleaning validation protocol

The report has been prepared, reviewed and approved by the following personnel.

DESIGNATION NAME SIGNATURE DATE

PREPARED BY

OFFICER/EXECUTIVE-QA

REVIEWED BY

HEAD-PRODUCTION

HEAD-QC

HEAD-ENGINEERING

APPROVED BY

HEAD-QA
 DAXIN PHARMACEUTICALS PVT. LTD.
BADDI

Report No.: CLEANING VALIDATION Reference Protocol No.:

DPPL/CVR/001-00 REPORT DPPL/CVP/001-00
Revision No.: 00
Supersede: Nil Effective Date:
Product Name : Ofloxacin Tablets IP 200 mg Page 4 of 12

1.0 OBJECTIVE
1.1 The objective of this cleaning validation report is to provide and document all the data and
results generated during the cleaning validation activity on product Ofloxacin Tablets IP 200
mg to demonstrate efficiency of the cleaning procedure used in the manufacturing
department.
1.2 To review results obtained during cleaning validation on Ofloxacin Tablets IP 200 mg
against the acceptance limit and to suggest any change in cleaning procedure/CAPA, if any
deviation observed.
1.3 To set up guideline to establish residue limits, cleaning, sampling and testing procedure for
routine verification of cleaning procedure.

2.0 SCOPE
This cleaning validation report is applicable for the compilation of results obtained during
the validation of cleaning processes performed in the manufacturing department for cleaning
of equipments, utensils and components. The scope of this report is limited to the Cleaning
validation of the three batches of product Ofloxacin Tablets IP 200 mg worst case Product
for verification of cleaning effectiveness.
 DAXIN PHARMACEUTICALS PVT. LTD.
BADDI

Report No.: CLEANING VALIDATION Reference Protocol No.:

DPPL/CVR/001-00 REPORT DPPL/CVP/001-00
Revision No.: 00
Supersede: Nil Effective Date:
Product Name : Ofloxacin Tablets IP 200 mg Page 5 of 12

3.0 RESPONSIBILITY, VALIDATION TEAM & COMMITTEE

Validation Team
Officer/Executive-Production:
 Cleaning of equipment’s as per approved standard cleaning procedure.
 Initiation of any changes or deviation occurred during the validation study.

Officer/Executive-QC:
 Timely submission of all the analytical/micro data and reports to Quality Assurance.
 Initiation of any changes or deviation occurred during the validation study.

Officer/Executive-QA:
 Collection and review of validation data.
 Compilation of final report and submit to Validation Organization Committee.
 Handling of any change control or deviation occurred during the validation study.
Validation Organization Committee
 The responsibilities of the overall scope of cleaning validation.
 Overall co-ordination of the cleaning validation program.
 To report to management on the progress of the cleaning validation report.
 Approval of any protocol amendments, if necessary.
 Review and approval of the final cleaning validation report.
 DAXIN PHARMACEUTICALS PVT. LTD.
BADDI

Report No.: CLEANING VALIDATION Reference Protocol No.:

DPPL/CVR/001-00 REPORT DPPL/CVP/001-00
Revision No.: 00
Supersede: Nil Effective Date:
Product Name : Ofloxacin Tablets IP 200 mg Page 6 of 12

Cleaning Validation Organization Committee/Team:

Committee: Head- QA
Head- QC
Head- Production
Head-Engineering

Validation: Executive/Officer- QA
Team Executive/Officer- QC
Executive/Officer- Prod.
Executive/Officer- Engineering

Execution:
Persons from User Department
QC, QA, Engineering & Production
 DAXIN PHARMACEUTICALS PVT. LTD.
BADDI

Report No.: CLEANING VALIDATION Reference Protocol No.:

DPPL/CVR/001-00 REPORT DPPL/CVP/001-00
Revision No.: 00
Supersede: Nil Effective Date:
Product Name : Ofloxacin Tablets IP 200 mg Page 7 of 12

4.0 TRAINING RECORD OF PERSONNEL INVOLVED : Training shall be imparted to

all the concern person who shall be involved in the execution of Cleaning Validation.
TRAINER NAME:
DEPARTMENT:
DESIGNATION:

S. No. Name of Trainee Department Sign &date

Remarks:

Evaluated by:
(Sign/date)
 DAXIN PHARMACEUTICALS PVT. LTD.
BADDI

Report No.: CLEANING VALIDATION Reference Protocol No.:

DPPL/CVR/001-00 REPORT DPPL/CVP/001-00
Revision No.: 00
Supersede: Nil Effective Date:
Product Name : Ofloxacin Tablets IP 200 mg Page 8 of 12

5.0 OVERVIEW:
 The cleaning validation report has been prepared for compilation of results after
completion of cleaning, sampling and analysis of three validation batches of product
Ofloxacin Tablets IP 200 mg.
 The cleaning validation report is being prepared based on the results of swab and rinse
water sampling conducted during the validation activity.
 On the basis of equipment design and cleaning validation results of swab sampling from
different locations of equipment, worst case locations for routine sampling and testing
has been identified for each equipment.
6.0 PRODUCT & BATCH DETAILS:

Product Name Ofloxacin Tablets IP 200 mg

Generic Name Ofloxacin Tablets IP 200 mg

Each film coated tablet contains
Label claim/composition
Ofloxacin IP…………200 mg
Batch size 48.0 Kg

Dosage Form Tablet

Round, biconvex, white coloured film coated tablet plain on
Product Description
both sides
Batch No.
Batch
Mfg. Date
Details
Exp. Date

7.0 ACCEPTANCE LIMIT

7.1 Acceptance Limit for Visual Inspection:
 DAXIN PHARMACEUTICALS PVT. LTD.
BADDI

Report No.: CLEANING VALIDATION Reference Protocol No.:

DPPL/CVR/001-00 REPORT DPPL/CVP/001-00
Revision No.: 00
Supersede: Nil Effective Date:
Product Name : Ofloxacin Tablets IP 200 mg Page 9 of 12

 The equipments, utensils and areas shall be visually clean.

 No visible residue of previous product i.e. Clear colourless liquid shall be present
on the equipment surfaces.

7.2 Acceptance Limit for Swab and Rinse water Samples (Chemical Analysis):

Sample for chemical analysis Limit

Swab Sample NMT 0.8 ppm or µg/swab

Rinse water NMT 1.35 ppm or µg/ml

7.3 Acceptance Limit for Swab and Rinse water Samples (Micro Analysis):

Sample for Microbiological analysis Limit

Total aerobic microbial count NMT 50 cfu/swab

Total combined yeast and Mould count NIL

8.0 RESULTS AND OBSERVATIONS:

 Analytical data sheets and records (chemical and microbiological) of cleaning validation
results shall be attached with the cleaning validation report.
 Based on the Obtained data, chemical results for rinse and swab samples shall be
complied and recorded in Annexure-I & II.
 Microbiological results of swab samples of different equipment’s shall be recorded in
Annexure-III.
 Results and data (chemical and microbiological) of all three consecutive batches under
validation shall be verified against the respective acceptance limit as specified in point
No.7.0.
 DAXIN PHARMACEUTICALS PVT. LTD.
BADDI

Report No.: CLEANING VALIDATION Reference Protocol No.:

DPPL/CVR/001-00 REPORT DPPL/CVP/001-00
Revision No.: 00
Supersede: Nil Effective Date:
Product Name : Ofloxacin Tablets IP 200 mg Page 10 of 12

9.0 DEVIATION

10.0 SUMMARY

11.0 CONCLUSION
 DAXIN PHARMACEUTICALS PVT. LTD.
BADDI

Report No.: CLEANING VALIDATION Reference Protocol No.:

DPPL/CVR/001-00 REPORT DPPL/CVP/001-00
Revision No.: 00
Supersede: Nil Effective Date:
Product Name : Ofloxacin Tablets IP 200 mg Page 11 of 12

12.0 CLEANING VALIDATION REPORT POST APPROVAL

DESIGNATION NAME SIGNATURE DATE

PREPARED BY

OFFICER/EXECUTIVE-QA

REVIEWED BY

HEAD-PRODUCTION

HEAD-QC

HEAD-ENGINEERING

APPROVED BY

HEAD-QA
 DAXIN PHARMACEUTICALS PVT. LTD.
BADDI

Report No.: CLEANING VALIDATION Reference Protocol No.:

DPPL/CVR/001-00 REPORT DPPL/CVP/001-00
Revision No.: 00
Supersede: Nil Effective Date:
Product Name : Ofloxacin Tablets IP 200 mg Page 12 of 12

13.0 ABBREVIATIONS

Short Form Long Form

QA Quality Assurance
QC Quality Control
ppm Parts Per Million
µg Microgram
cfu Colony forming unit

14.0 ANNEXURES
 Annexure-I : Cleaning Validation Results of Rinse sample (Chemical)
 Annexure-II : Cleaning Validation Results of Swab sample (Chemical)
 Annexure-III : Cleaning Validation Results of Swab sample (Micro)