Sop for Validation report for disinfectant efficacy

EFFECTIVE DATE OF REPORT
DATE OF QUALIFICATION
SUPERSEDES REPORT No.

REPORT CONTENTS

Sr. No.	TITLE	PAGE No.
	REPORT PRE APPROVAL
	OBJECTIVE
1.	SCOPE
2.	RESPONSIBILITY
3.	EQUIPMENTS DETAILS
4.	REASON FOR QUALIFICATION
5.	SITE OF STUDY
6.	FREQUENCY QUALIFICATION
7.	ANNEXURES
8.	REFERENCES
9.	DOCUMENTS TO BE ATTACHED
10.	DEVIATION FROM PRE-DEFINED PARAMETERS, IF ANY
11.	CHANGE CONTROL, IF ANY
12.	REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY
13.	CONCLUSION
14.	RECOMMENDATION
15.	ABBREVIATION
16.	REVISION HISTORY
17.	REPORT POST APPROVAL

1.0 REPORT PRE APPROVAL:

PREPARED BY:

DESIGNATION

NAME

SIGNATURE

DATE

OFFICER/EXECUTIVE

(MICROBIOLOGY)

REVIEWED BY:

DESIGNATION

NAME

SIGNATURE

DATE

OFFICER/EXECUTIVE

(MICROBIOLOGY)

APPROVED BY:

DESIGNATION

NAME

SIGNATURE

DATE

OFFICER/EXECUTIVE

(MICROBIOLOGY)

2.0 OBJECTIVE:
To provide documented evidence, that the disinfectants used are

suitable to control microorganisms present in the manufacturing

area, packing area and service area and record the data as per protocol.

3.0 SCOPE:
The Report covers all aspects of validation aspects of various

disinfectants used in Production area, Microbiology area

The protocol is applicable for checking the Efficacy of

the Disinfectants, Contact Time and Efficacy of Application

of Working Concentration of the disinfectants.

4.0 RESPONSIBILITY:
The Validation Group, comprising of a representative from

each of the following departments, shall be responsible for

the execution of Performance Qualification Report.

DEPARTMENTS RESPONSIBILITIES

Quality Control • Preparation, Review and Compilation of the
Performance Qualification Report.
• Co-ordination with Production and Engineering to
Carryout Performance Qualification Activity.
• Monitoring of Performance Qualification Activity.
• Analytical Support (Microbial Testing/ chemical analysis).

Quality Assurance • Approval of disinfectant validation report.
• Co-ordination with Production and Engineering to
Carryout Performance Qualification Activity.

Production • Reviewing of Performance Qualification Report.
• To co-ordinate and support Performance Qualification
Activity.

Engineering • Reviewing of qualification report for correctness,
Completeness and technical excellence.
• Responsible for trouble shooting (if occurred during
Execution).
• Maintenance & preventive maintenance as per schedule.

5.0 EQUIPMENT DETAILS:

—

6.0 REASON FOR QUALIFICATION:

Initial Study

7.0 SITE OF STUDY:

Microbiology department

8.0 FREQUENCY OF QUALIFICATION:

Once

9.0 ANNEXURES:
ANNEXURE – I
EFFICACY OF WORKING CONCENTRATION AND CONTACT TIME (IN-VITRO STUDY)

Name of Disinfectant		Volume of Culture
Concentration Used		Dilution Factor of Culture Susp.
Date of Test		Date of Completion

Sr. No.	Name of Organism	No. of CFU Inoculated	Contact Time	Organism Recovery After Incubation				Log Reduction (Recovery against inoculated CFU)
Sr. No.	Name of Organism	No. of CFU Inoculated	Contact Time	Plate 1	Plate 2	Average	Avg. × Dilution Factor	Log Reduction (Recovery against inoculated CFU)
			Positive Control (Only organism without disinfectant)
			0 minute Test Surface (Organism + Disinfectant)
			5 minute Test Surface (Organism + Disinfectant)
			10 minute Test Surface (Organism + Disinfectant)

Negative Control (only disinfectant without any organism).

Done By (Microbiologist): Checked By:
Sign / Date: Sign / Date:

ANNEXURE-II
EFFICACY OF APPLICATION OF WORKING CONCENTRATION (SURFACE STUDY)

Surface Used		Volume of Culture
Name of Disinfectant		Concentration Used
Date of Test		Date of Completion

Sr. No.	Name of Organism	No. of CFU Inoculated	Contact Time	Organism Recovery After Incubation				Log Reduction (Recovery against inoculated CFU)
Sr. No.	Name of Organism	No. of CFU Inoculated	Contact Time	Plate 1	Plate 2	Average	Avg. × Dilution Factor	Log Reduction (Recovery against inoculated CFU)
			Positive Control (Only organism without disinfectant)
			0 minute Test Surface (Organism + Disinfectant)
			5 minute Test Surface (Organism + Disinfectant)
			10 minute Test Surface (Organism + Disinfectant)

Negative Control (only disinfectant without any organism).

Done By (Microbiologist): Checked By
Sign / Date: Sign / Date:

ANNEXURE-III
RESULT AND DISCUSSION

Name

of disinfectant

Conc. Used

coli

aeruginosa

B. subtilis

Candida albicans

Env.

Isolate

Observa-

tion

Result

REMARKS: The disinfectant is able / not able to bring 3 log reduction in the microorganism and is suitable / not suitable for use at above concentration.

Done By (Microbiologist): Checked By:
Sign / Date: Sign / Date:
Inference: ____________________________

Reviewed By:
(QUALITY ASSURANCE)
Sign / Date:

10.0 REFERENCE:
Validation Master Plan.
In house.
11.0 DOCUMENTS ATTACHED:
Microbiology Report
Any other relevant data

12.0 DEVIATION FROM PRE-DEFINED SPECIFICATION, IF ANY:

13.0 CHANGE CONTROL, IF ANY:

14.0 REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY ):

15.0 CONCLUSION :

16.0 RECOMMENDATION :

17.0 ABBREVIATIONS:

% : Percentage
cGMP : current Good Manufacturing Practices
ID. : Identification
Nacl : Sodium Chloride
No. : Number
PQ : Performance Qualification

18.0 REVISION HISTORY:

Revision