OBJECTIVE:
To lay down the procedure for Handling of samples in Microbiology laboratory.
SCOPE:
This SOP is applicable for the procedure for Handling of samples in Microbiology laboratory at {Company Name} {Location}.
RESPONSIBILITY:
Microbiologist: is responsible to perform the activity as per SOP.
In charge- Microbiology- is responsible to ensure compliance as per SOP.
Head/Designee Quality Control – Shall be responsible for ensuring compliance as per SOP.
ACCOUNTABILITY:
QA Head shall be Accountable for implementation of SOP.
ABOUT MICROBIAL SAMPLE HANDLING:
Handling samples in a microbiology lab is crucial, especially in the pharmaceutical industry, to ensure product safety and efficacy. It begins with meticulous collection using sterile techniques and validated containers, preventing contamination of raw materials, in-process materials, and finished products. Samples must be clearly labeled with detailed information, including product name, batch number, collection date/time, and any specific storage requirements.
Timely and controlled transport to the lab is essential, often under precise temperature and environmental conditions to maintain sample integrity and microbial viability. Upon arrival, samples are processed in designated lab areas, minimizing the risk of cross-contamination. Testing may involve sterility testing, microbial enumeration, pathogen identification, and endotoxin testing. Throughout the process, strict adherence to aseptic techniques, validated procedures, and regulatory guidelines (like GMP) is paramount. This ensures the reliability of results, which directly impacts decisions related to product release and patient safety.
PROCEDURE:
Receipt of sample:
Receive the sample and ensure the details of sample mentioned on the label against the request, In case any discrepancy observed intimate to In-charge Microbiology or Head-quality Control for corrective action.
Keep the samples in designated places labelled as “Samples to be analysed”.
Assigning of A. R. No. to samples:
All microbial samples shall be registered as per SOP.
AR no shall be assigned for the samples not having privileges in LIMS to register. For example cleaning validation sample or swab samples, method suitability samples, equipment qualification/validation samples, compressed air samples and miscellaneous samples for microbiological analysis. AR. No. Shall be assigned with 12 characters in the sample register (manual registration) as per Format-I.
E.g.: MIC/29/00001
Where
MIC – Microbiology sample
“/” (Slash).
29- indicate the calendar year of analysis.
“ / ” (Slash).
00001- denote the serial number.
Every calendar year starts with new A.R. Number.
Sample allotment and testing:
Section In-charge shall approve the sample, Senior executive / Group leader shall in turn delegate individual tests to concerned analyst.
After delegation, the analyst shall take worksheets.
Analyst shall mark all the testing plates with the following details.
- AR. No., of the product,
- Media Batch No.,
- Date of analysis.
Analyst shall perform the tests as per approved analytical testing procedures.
After completion of analysis, the analyst shall enter the test results in work sheet. Completed worksheet shall be handed over to Group leader / Designee.
Group leader / Designee shall review and approve the delegated tests after checking the worksheet and final approval shall be given by Section in-charge/Designee.
Handling of leftover samples:
After the completion of analysis follow SOP for disposal of leftover samples.
Protocol Numbering System for method validation/non routine study:
Microbiological Method validation/ non routine study protocol Number shall consists of 14 characteristics.
MMVP – Microbiological Method validation Protocol. 4
/- slash
29- stand for the year (29 for 2029, 30 for 2030 and so on).
(-) – hyphen
001- three digits serial number (001).
(-)- hyphen
00- are stands for version number (00).
E.g.: First Microbiological method validation Protocol/non routine study protocol of 2029 shall be given as MMVP/29-001-00.
Click the link to download word file copy of this document:
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REFERENCES:
Not Applicable
ANNEXURES:
| ANNEXURE NO. | TITLE OF ANNEXURE |
| Annexure-I | Sample register (Manual registration) |
ENCLOSURES: SOP Training Record.
DISTRIBUTION:
Controlled Copy No. 01 : Head Quality Assurance
Controlled Copy No. 02 : Head Quality Control (Micro.)
Master Copy : Quality Assurance Department
ABBREVIATIONS:
| No. | : | Number |
| IPA | : | Iso Propyl Alcohol |
| SOP | : | Standard Operating Procedure |
| QC | : | Quality Control |
REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | Write manual |
Annexure-I
SAMPLE REGISTER (MANUAL REGISTRATION)
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/handling-of-samples-in-microbiology-laboratory/
