SOP for daily GMP checks
OBJECTIVE: To provide Guidelines for Daily GMP Checks.
SCOPE:1. This SOP provides guidelines regarding procedure for daily GMP checks to be performed by QA thrice a day (i.e. initial, middle & at the end of shift).
2.Daily GMP checks are important for maintaining & improving quality of product and working system.
REFERENCE:
In house
RESPONSIBILITY:
QA personnel – To carry out daily GMP checks as per frequency.
ABBREVATIONS:
SOP : Standard Operating Procedure
QA : Quality assurance
HOD : Head of the department
QC : Quality control
PROCEDURE:
1. GMP checks to be performed by QA personnel daily three times a day (initial, middle & final)
2. Daily GMP checks are to be performed for following Departments
a. Production
b. QC/Microbiology
c. Maintenance
d. Store
3. Department wise following observations have to be noted.
3.1 PRODUCTION
a. Check the records of insect killer, area cleaning, temperature, relative humidity & differential pressure, Balance calibration, BMR/BPR, Log books.
b. Check the gowning conditions, electronic lock system of pass boxes & doors (During working always keep it “ON” position) & status labeling.
3.2 QC/MICROBIOLOGY
a. Check the records of equipment log books, balance calibration, area cleaning, stability chamber log books, media destruction & preparation log book.
b. Check the status of equipment calibration.
3.3 MAINTENANCE
a. Check the records of sanitization & regeneration of purified water system, HVAC & filter cleaning, HVAC differential pressure.
b. Check the log sheet of purified water system.
3.4 STORE
a. Check the records of temperature, relative humidity & differential pressure, log books of dispensing & sampling area, balance calibration.
b. Check the cleaning records of dispensing & sampling areas, RLAF filters, dispensing tools.
c. Check the gowning conditions, raw/packaging material status labels.
4. Daily GMP check record is prepared and furnished as per Annexure1. In observation column if found “OK” then mark as (√), if found “NOT OK” (i.e. GMP not followed) then mark as (x).
5. At the end of the day take the signatures of respective HODs for their information regarding GMP compliances.
6. These records are for internal purpose for the enhancement of Quality system of Scitech Specialities and not to be shown to external auditors.
FREQUENCY:
Initial, Middle, Final visit during working day.
ANNEXURE:
Annexure 1- Daily GMP check Records
Annexure 1- Daily GMP check Records
Sr. No Departments/ Quality checks Time Sunday Monday Tuesday Wednesday Thursday Friday
Observation Observation Observation Observation Observation Observation
I. Production
1. Insect Killer record
2. Cleaning Records
3. Gowning conditions
4. Temperature, Relative Humidity & Differential Pressure
5. BMR/BPR
6. Log Books
7. Balance Calibration Records
8. Pass boxes/Doors
9. Status Labels
II. QC/Microbiology
1. Equipment log books
2. Balance calibration record
3. Cleaning Record
4. Stability chamber log book
5. Calibration labels
6. Media destruction & preparation log book
III. Maintenance
1. Log sheet of purified water system
2. Sanitization & Regeneration Records
IV. Store
1. Temperature, Relative Humidity & Differential pressure
2. Log Book of Dispensing Area/ Sampling Area
3. Cleaning Records of dispensing tools
4. Cleaning records of RLAF filters
5. Area cleaning record
6. Balance Calibration record
7. Gowning condition
8. Raw/Packagin
g material status labels
Sign/Date
HODs PRODUCTION QC/MICROBIOLOGY MAINTENANCE STORE