SOP For Good Microbiological Laboratory Practice.
The Purpose of SOP For Good Microbiological Laboratory Practice to lay out the procedure of Good Microbiological Laboratory Practice in Non- Sterile Pharmaceutical Products manufacturing plant.
This SOP is applicable for Good Microbiological Laboratory Practice in the Microbiology Laboratory at Non- Sterile Pharmaceutical Products manufacturing plant.
Microbiologist & his designee and lab assistant shall be responsible for following Good Microbiological Laboratory Practice.
The Head of Microbiology shall be responsible for effective implementation of the SOP.
QA department shall be responsible for review and approval of the SOP
The general health condition of personnel must be satisfactory. Staff with open wounds, any skin ailment or any respiratory tract infection must not be permitted to work in Microbiology laboratory.
All staff should maintain personal hygiene.
Hair shall be kept clean and covered with a cap while working in the laboratory.
Laboratory coats or factory uniform shall always be clean.
All staff should strictly follow gowning and De-gowning procedure.
Nails of persons working in the laboratory shall be regularly trimmed.
Jewelry and unnecessary cosmetics shall not be worn in Microbiology Laboratory.
Activity of personnel
Staff should not move unnecessarily in Microbiology testing areas because movement increases particulate shedding.
Persons engaged in maintenance work must observe the same precautions and hygiene standards as laboratory personnel
Staff working in Microbiological testing areas should wear special garments, which are non-shedding, comfortable to wear and lose fitting.
The garments should have no external pockets or unnecessary tucks. Edges of the garments should be sealed and seams should be all-enveloping.
The garments should be cleaned in such a way that they do not gather Contaminants, which can later be shed while working.
Before use, the garments must be sterilized.
The sterilized garment once opened should be used immediately for Microbiology Testing area.
General care to be taken during work:-
The pass box shall be used as per SOP for transfer of material from unclassified to classified area.
Personnel should not lean into the laminar airflow bench or place his / her hands on the bench.
No articles/glassware should be placed on top of the laminar airflow bench. Clean, dried glassware shall be used for Media preparation.
Sterile disposable plastic Petri plates shall be handled with care. Sterile disposable plastic Petri plates shall be handled with care. Petri plates should be opened only in the laminar airflow bench.
The aseptic procedure should be followed during Microbial testing.
Testing should be carried out as per the approved latest version of the standard test procedure.
Log books should be maintained systemically. Keep the log book or any material on the same place after completion of work.
Use the refrigerated Media, culture, and water after attaining the room temperature.
Whenever performing serial dilution vortex the tubes properly for accurate results.
Raw data should be maintained properly and the observation should be recorded contemporaneously.
Any correction made to a document or record must be signed or initialed and dated; the correction must permit the reading of the original information. Where appropriate, the reason for correction must be recorded.
In case the testing is done in Microbiology testing area if you need to fill raw data then fill the data as soon as possible after completion of work. & Humidity of the area should be maintained.
Record of pressure differential should be maintained.
The stock of media should be maintained as per SOP.
Cleanliness of the area to be maintained while working in the area.
Handle live culture carefully; in case of any spillage follow culture spillage management procedure.
Ensure to decontaminate the tested media/plate etc. before disposal.
Training shall be given to all Microbiologists & Lab Assistants.