sop for validation report for preservative efficacy test
PRODUCT NAME
| PRODUCT NAME |
|
| BATCH NUMBER | |
| PRESERVATIVE NAME | |
| DATE OF TESTING | |
| DATE OF COMPLETION |
REPORT CONTENTS
| S. No. | Title | Page No.
|
| 1.0 | Pre-Approval | |
| 2.0 | Objective | |
| 3.0 | Scope | |
| 4.0 | Responsibility | |
| 5.0 | Training record | |
| 6.0 | Observation | |
| 7.0 | Acceptance criteria | |
| 8.0 | References | |
| 9.0 | Documents to be attached | |
| 10.0 | Deviation from pre-defined specification, if any | |
| 11.0 | Change control, if any | |
| 12.0 | Review (inclusive of follow up action, if any ) | |
| 13.0 | Conclusion | |
| 14.0 | Recommendation | |
| 15.0 | Abbreviations |
1.0 REPORT PRE -APPROVAL:
PREPARED BY:
| DESIGNATION | NAME | SIGNATURE | DATE |
| OFFICER/EXECUTIVE
(MICROBIOLOGY) |
REVIEWED BY:
| DESIGNATION | NAME | SIGNATURE | DATE |
| EXECUTIVE/MANAGER
(MICROBIOLOGY) |
|||
| HEAD
(PRODUCTION) |
|||
| HEAD
(ENGINEERING) |
|||
| HEAD
(QUALITY CONTROL) |
APPROVED BY:
| DESIGNATION | NAME | SIGNATURE | DATE |
| HEAD
(QUALITY ASSURANCE) |
2.0 OBJECTIVE:
To establish methodology for testing of Efficacy of Preservatives added in products
3.0 SCOPE:
Antimicrobial preservatives are substances added to products to protect them from microbiological growth or from microorganisms that are introduced inadvertently during or subsequent to the manufacturing process. In the case of products packaged in multiple-dose containers, antimicrobial preservatives are added to inhibit the growth of microorganisms that may be introduced from repeatedly withdrawing individual use doses.
4.0 RESPONSIBILITY:
The Validation Group, comprising of a representative from each of the following departments, shall be responsible for the overall compliance of this report.
| DEPARTMENTS | RESPONSIBILITIES |
| Quality Control | Preparation, Review of the preservative efficacy test validation Report.
Sampling as per protocol. To conduct the validation study as per protocol. To perform the microbiological monitoring. Protocol Training. |
| Quality Assurance | Co-ordination with Quality Control, Production and Engineering to preservative efficacy test validation. |
| Production | Review & Approval of report.
To co-ordinate and support preservative efficacy test validation. |
| Engineering | Review & Approval of report.
Co-ordination, Execution and technical support in preservative efficacy test validation. |
5.0 TRAINING ATTENDANCE RECORD:
Name of Trainer: _______________________ Training Date: ________________
Type of Training: _______________________
| S. No. | Name of Trainee | Designation | Department Name | Training given on Protocol (Yes/No) |
* Copy of Training Record to be attached.
Compiled By:
Sign & Date …………………………
Inference: ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Reviewed By: ¬¬¬¬
Sign & Date ………………..
6.0 OBSERVATION
6.1 OBSERVATION OF CULTURE SUSPENSION:
I
| INOCULUM DETAILS | : Date of Inoculums Preparation: ……………… Date of observation: …………….. | ||||||||||
| Name of culture | In house Media Used | Cfu/ml observed with respect to dilution | Selected dilution | ||||||||
| 10-2 | 10-3 | 10-4 | 10-5 | 10-6 | 10-7 | 10-8 | 10-9 | ||||
| E. coli |
|
||||||||||
| Staph. aureus |
|
||||||||||
| Ps. aeruginosa |
|
||||||||||
| C. albicans |
|
||||||||||
| A. brasiliensis |
|
||||||||||
Analyst Checked by
(Sign & Date): (Sign & Date):
6.2 OBSERVATION DETAILS (FIRST SAMPLE) AFTER 0 HOURS:
| Name of culture | Media Used | Cfu/ml observed with respect to dilution | ||||||
| 10-2 | 10-3 | 10-4 | 10-5 | 10-6 | 10-7 | 10-8 | ||
| E. coli | ||||||||
| Staph. aureus | ||||||||
| Ps. aeruginosa | ||||||||
| C. albicans | ||||||||
| A. brasiliensis | ||||||||
Analyst Checked by
(Sign & Date): (Sign & Date):
6.3 OBSERVATION DETAILS(FIRST SAMPLE) AFTER 7 DAYS:
Date of Testing: …………………………… Date of Observation: ……………………………………
| Name of culture | Media Used | Cfu/ml observed with respect to dilution | ||||||
| 10-2 | 10-3 | 10-4 | 10-5 | 10-6 | 10-7 | 10-8 | ||
| E. coli | ||||||||
| Staph. aureus. | ||||||||
| Ps. aeruginosa | ||||||||
| C. albicans | ||||||||
| A. brasiliensis | ||||||||
Analyst Checked by
(Sign & Date): (Sign & Date):
6.4 OBSERVATION DETAILS(FIRST SAMPLE) AFTER 14 DAYS:
Date of Testing: ……………………………….. Date of Observation: ……………………………
| Name of culture | Media Used | Cfu/ml observed with respect to dilution | ||||||
| 10-2 | 10-3 | 10-4 | 10-5 | 10-6 | 10-7 | 10-8 | ||
| E. coli | ||||||||
| Staph. aureus. | ||||||||
| Ps. aeruginosa | ||||||||
| C. albicans | ||||||||
| A. brasiliensis | ||||||||
Analyst Checked by
(Sign & Date): (Sign & Date):
6.5 OBSERVATION DETAILS (FIRST SAMPLE) AFTER 28 DAYS:
Date of Testing: ……………………………….. Date of Observation: ……………………………………
| Name of culture | Media Used | Cfu/ml observed with respect to dilution | ||||||
| 10-2 | 10-3 | 10-4 | 10-5 | 10-6 | 10-7 | 10-8 | ||
| E. coli | ||||||||
| Staph. aureus | ||||||||
| Ps. aeruginosa | ||||||||
| C. albicans | ||||||||
| A. brasiliensis | ||||||||
Analyst Checked by
(Sign & Date): (Sign & Date):
6.6 OBSERVATION DETAILS(SECOND SAMPLE) AFTER 0 HOURS:
Date of Testing: ………………………… Date of Observation: ………………………
| Name of culture | Media Used | Cfu/ml observed with respect to dilution | ||||||
| 10-2 | 10-3 | 10-4 | 10-5 | 10-6 | 10-7 | 10-8 | ||
| E. coli | ||||||||
| Staph. aureus | ||||||||
| Ps. aeruginosa | ||||||||
| C. albicans | ||||||||
| A. brasiliensis | ||||||||
Analyst Checked by
(Sign & Date): (Sign & Date):
6.7 OBSERVATION DETAILS(SECOND SAMPLE) AFTER 7 DAYS:
Date of Testing: …………………………… Date of Observation: ……………………………………
| Name of culture | Media Used | Cfu/ml observed with respect to dilution | ||||||
| 10-2 | 10-3 | 10-4 | 10-5 | 10-6 | 10-7 | 10-8 | ||
| E. coli | ||||||||
| Staph. aureus. | ||||||||
| Ps. aeruginosa | ||||||||
| C. albicans | ||||||||
| A. brasiliensis | ||||||||
Analyst Checked by
(Sign & Date): (Sign & Date):
6.8 OBSERVATION DETAILS (SECOND SAMPLE) AFTER 14 DAYS:
Date of Testing: ……………………………….. Date of Observation: ……………………………
| Name of culture | Media Used | Cfu/ml observed with respect to dilution | ||||||
| 10-2 | 10-3 | 10-4 | 10-5 | 10-6 | 10-7 | 10-8 | ||
| E. coli | ||||||||
| Staph. aureus. | ||||||||
| Ps. aeruginosa | ||||||||
| C. albicans | ||||||||
| A. brasiliensis | ||||||||
(Sign & Date): (Sign & Date):
6.9 OBSERVATION DETAILS (SECOND SAMPLE) AFTER 28 DAYS:
Date of Testing: ……………………………….. Date of Observation: ……………………………………
| Name of culture | Media Used | Cfu/ml observed with respect to dilution | ||||||
| 10-2 | 10-3 | 10-4 | 10-5 | 10-6 | 10-7 | 10-8 | ||
| E. coli | ||||||||
| Staph. aureus | ||||||||
| Ps. aeruginosa | ||||||||
| C. albicans | ||||||||
| A. brasiliensis | ||||||||
Analyst Checked by
(Sign & Date): (Sign & Date):
6.10 OBSERVATION DETAILS (THIRD SAMPLE) AFTER 0 HOURS:
| Name of culture | Media Used | Cfu/ml observed with respect to dilution | ||||||
| 10-2 | 10-3 | 10-4 | 10-5 | 10-6 | 10-7 | 10-8 | ||
| E. coli | ||||||||
| Staph. aureus | ||||||||
| Ps. aeruginosa | ||||||||
| C. albicans | ||||||||
| A. brasiliensis | ||||||||
Analyst Checked by
(Sign & Date): (Sign & Date):
6.11 OBSERVATION DETAILS(THIRD SAMPLE) AFTER 7 DAYS:
Date of Testing: …………………………… Date of Observation: ……………………………………
| Name of culture | Media Used | Cfu/ml observed with respect to dilution | ||||||
| 10-2 | 10-3 | 10-4 | 10-5 | 10-6 | 10-7 | 10-8 | ||
| E. coli | ||||||||
| Staph. aureus. | ||||||||
| Ps. aeruginosa | ||||||||
| C. albicans | ||||||||
| A. brasiliensis | ||||||||
Analyst Checked by
(Sign & Date): (Sign & Date):
6.12 OBSERVATION DETAILS (THIRD SAMPLE) AFTER 14 DAYS:
Date of Testing: ……………………………….. Date of Observation: ……………………………
| Name of culture | Media Used | Cfu/ml observed with respect to dilution | ||||||
| 10-2 | 10-3 | 10-4 | 10-5 | 10-6 | 10-7 | 10-8 | ||
| E. coli | ||||||||
| Staph. aureus. | ||||||||
| Ps. aeruginosa | ||||||||
| C. albicans | ||||||||
| A. brasiliensis | ||||||||
Analyst Checked by
(Sign & Date): (Sign & Date):
6.13 OBSERVATION DETAILS (THIRD SAMPLE) AFTER 28 DAYS:
Date of Testing: ……………………………….. Date of Observation: ……………………………………
| Name of culture | Media Used | Cfu/ml observed with respect to dilution | ||||||
| 10-2 | 10-3 | 10-4 | 10-5 | 10-6 | 10-7 | 10-8 | ||
| E. coli | ||||||||
| Staph. aureus | ||||||||
| Ps. aeruginosa | ||||||||
| C. albicans | ||||||||
| A. brasiliensis | ||||||||
Analyst Checked by
(Sign & Date): (Sign & Date):
7.0 ACCEPTANCE CRITERIA:
The preservative is effective in the product examined if (a) the concentration of bacteria are not than 10 percent of the initial concentrations at 7 day and not more than 0.1 percent of the initial concentration at 14 day and there is a further decrease in count at 28 day. (b) Yeast and moulds: no increase from the initial calculated count at 7 day, 14 day, and 28 day.
8.0 REFERENCES:
Indian pharmacopoeia.
In house.
9.0 DOCUMENTS TO BE ATTACHED:
Raw data generated during testing.
Any Other Relevant Documents.
10.0 DEVIATION FROM PRE-DEFINED SPECIFICATION, IF ANY:
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….
11.0 CHANGE CONTROL, IF ANY:
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….
12.0 REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY ):
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………
…………………………………………………………………………………………
13.0 CONCLUSION :
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
14.0 RECOMMENDATION :
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
15.0 ABBREVIATIONS:
QC Quality Control
Ltd. Limited
SOP Standard Operating Procedure
°C Degree Celsius
QA Quality Assurance
ID. No. Identification Number
NA Not Applicable
SCDA Soyabean Casein Digest Agar
IH In-house
LAF Laminar Air Flow
16.0 REPORT POST -APPROVAL:
PREPARED BY:
| DESIGNATION | NAME | SIGNATURE | DATE |
| OFFICER/EXECUTIVE
(MICROBIOLOGY) |
REVIEWED BY:
| DESIGNATION | NAME | SIGNATURE | DATE |
| EXECUTIVE/MANAGER
(MICROBIOLOGY) |
|||
| HEAD
(PRODUCTION) |
|||
| HEAD
(ENGINEERING) |
|||
| HEAD
(QUALITY CONTROL) |
APPROVED BY:
| DESIGNATION | NAME | SIGNATURE | DATE |
| HEAD
(QUALITY ASSURANCE) |
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