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qualification for the personnel entering in to aseptic area

 

qualification for the personnel entering in to aseptic area

 

1.0 OBJECTIVE:
To lay down a Procedure to define the Standard Operating Procedure for “Qualification for the personnel entering in to Aseptic Area”.

2.0 SCOPE:
2.1 This SOP is applicable for Qualification for the personnel entering into Aseptic Area by Training, Gowning and Microbiological method

3.0 RESPONSIBILITY :
3.1 Production/Engineering/QA/QC In-Charge: To provide the training on specified topics along with requisition to Microbiology section for further qualification activity.
3.2 Microbiologist (Officer/Executive): Provide the qualification no. & Evaluation of training, Gowning &
Microbiological analysis results of three consecutive working days.
3.3 Quality Assurance: Review & maintain the qualified personnel list for aseptic area.



4.0 ACCOUNTABILITY:
4.1 QC Manager
4.2 Head-Quality Assurance shall be accountable for ensuring over all compliance of this Standard Operating Procedure.

 

5.0 PROCEDURE:
5.1 Only qualified personnel shall enter in the aseptic processing area or microbiology aseptic area.
5.2 After induction training person shall report to Section Head for assessment.
5.3 Section Head shall provide the following SOP’s training and evaluate his successful competency:
Personnel Hygiene
Entry and Exit of Aseptic Area of respective section.
Gowning procedure of Aseptic Area of respective section.
Cleaning & sanitation of Aseptic Area of respective section.
Aseptic Practices in aseptic area
Personnel monitoring procedure by contact plate and finger dab.
5.4 Personnel under qualification should obtain 100 % marks in evaluation through questionnaire of above trainings

and  No abnormalities should be found with respect to SOP after training.
5.5 If training evaluation not up to the mark as above criteria, retraining shall require with increased training hours.
5.6 Concern area department head shall initiate the requisition for personnel qualification as Annexure-I,

Titled “Requisition for Personnel Qualification for Aseptic Area” along with trainings  record and  filled questionnaire.
5.7 After receipt the requisition form concern area, microbiologist shall generate the Qualification no. as Annexure-II,

Titled “Record of Personnel Qualification Requisition”.
5.8 The microbiologist shall perform personnel qualification for the personnel entering into the aseptic processing area or

microbiology aseptic area. Persons are qualified by undergoing into three kinds of tests. :
Training Evaluation
Physical Gowning Procedure Verification
Gowning Procedure Qualification by Microbiological Method
5.8.1 Physical gowning procedure verification:
5.8.1.1 Qualified Microbiologist shall accompany with personnel for observe the gowning procedure as per




Entry and Exit procedure for Manufacturing and Microbiology Aseptic Area and record the observation.
5.8.1.2 If above check list observation not up to the mark (Evaluated by qualified microbiologist) again re training shall require with increasing (i.e. hour) frequency.
5.8.1.3 If again disqualify, microbiologist shall give the comments as not suitable for aseptic area & recommended for less critical activity working.
5.8.2 Gowning procedure qualification by microbiological method (contact plate & finger dab)
5.8.2.1 Gowning procedure shall be performed by “Contact Plate and Finger Dab” by three consecutive working days monitoring.
5.8.2.2 Incubate plate at 20-25°C for 72 hrs. & then incubate at 30-35°C for 48 hrs. After Completion of incubation record the observation in Annexure IV.
5.9 Acceptance criteria for personnel monitoring by contact plate and finger dab:
5.9.1 Following acceptance criteria shall be considered during evaluation of personnel qualification.

Grade Alert limits Action limits Limits

Grade Alert limits Action limits Limits
A <1 cfu <1 cfu <1 cfu
B 3 cfu 4 cfu                   5 cfu

5.9.2 Only two attempts shall be providing for personnel qualification activity.
5.9.3 All personnel who are authorized to enter the aseptic processing room during manufacturing, including

technicians and maintenance personnel, should participate in a media fill at least once a year.
5.10 Frequency:
5.10.1 Initial and Re – Qualification of the personnel:
5.10.1.1 Initial Qualification: Whenever a new person entry is required in aseptic criteria.
5.10.1.2 Periodic Qualification: A qualified person undergoes periodically for his correctness once in a year (±30 days).

(Only Gowning Qualification by Microbiological Method at periodic).
5.10.1.3 Re-Qualification:
A person who fails to show aseptic practices / Gowning procedure / excessive microbial count in routine personnel monitoring tests.
A person who is not regular attendee to the aseptic area gowning procedure (Above one year) willing to go into any Aseptic area.

A Person who availed longer medical leaves more than a 6 months and willing to go into Aseptic area.

5.11 Evaluation:
5.11.1 If three days’ personnel monitoring results found with in acceptance criteria:
5.11.1.1 After completion of Personnel qualification activity Microbiologist shall provide three days monitoring report to quality assurance department.
5.11.1.2 On the basis of three days monitoring a complete evaluation report shall be done w.r.t. Training records, Practices, personnel hygiene

and  Personnel monitoring results along with conclusion w.r.t. qualification status as Qualified.
5.11.1.3 After final approval person will be authorized to enter in aseptic area.
5.11.2 If three days personnel monitoring results found out of acceptance criteria:
5.11.2.1 After completion on Personal qualification activity a complete evaluation report shall be done w.r.t. Training records,

Practices, personnel hygiene and  Personnel monitoring results along with conclusion w.r.t. qualification status as Disqualified.
5.11.2.2 If personnel disqualify two times, microbiologist shall give the comments as not suitable for aseptic area & recommended for less critical activity working.

5.12 Flow chart of above procedure mentioned in Annexure-III, Titled “Flow Chart for Personnel Qualification”.

6.0 ABBREVIATION:
°C                        Degree Celsius
cfu                      Colony Forming Unit
Hrs.                     Hours
Ltd.                     Limited
Sr. No.                 Serial Number
QA                        Quality Assurance
QC                      Quality Control
SCDA                 Soybean Casein Digest Agar
SOP                      Standard Operating Procedure
USP                       United States Pharmacopeia

 

7.0 ATTACHMENTS  

Annexure-I :- Requisition for Personnel Qualification for Aseptic Area.
Annexure-II :- Record of Personnel Qualification Requisition
Annexure-III :- Flow Chart for Personnel Qualification
Annexure-IV :- Personnel Monitoring by contact plate & finger dab.

8.0 REFERENCE:

Sr. No. Reference Title
01. USP

 

qualification for the personnel entering in to aseptic area

sop for calibration and validation of micro autoclave

sop for Sterility failure investigation

cleaning and operation of discard autoclave

sop for operation of fogger machine

sop for Biological assay of lactic acid bacillus

sop for preparation of culture inoculum

STP for sterility testing of sterile gloves

sop for Operation and calibration of active air sampler

sop for transfer of material for testing and sampling in sterile area

entry & exit procedure in microbiology laboratory

Growth Promotion Test In Microbiology Laboratory

Operation of B.O.D in Microbiology Laboratory

Operation of Horizontal Laminar Air Flow in the microbiology laboratory

Operation and cleaning of Pass Box.

Operation and cleaning of air sampler

Cleaning and Sterilization of Glassware

Analysis of water for microbial load in microbiology lab

Operation and temperature monitoring of Refrigerator

Fumigation of Microbiology Laboratory.

Entry & Exit procedure In Sterility Area

SOP for Microbial analysis of Raw Material Finished Products

SOP for Operation & Calibration of pH meter in Micro Department

SOP for Operation & Calibration of pH meter in Micro Department

SOP Operation and calibration of Hot Air Oven In Microbiology

SOP for operation cleaning & calibration of Digital colony counter

SOP for Operation And Cleaning of Microscope

sop for Media Preparation and Consumption

sop for Receipt Storage and Usage of Culture Media

sop for Cleaning Sanitization And Disinfection In Microbiology

sop for Environmental monitoring of all the Classified area

sop for Handling and Sub culturing of Microbial cultures

sop for Media Growth Promotion Test and various Microbiological test

sop for BOD incubator operation and cleaning

sop sampling of water for microbiological analysis

sop for Disinfectant Efficacy Test

sop for for cleaning and operation of vortex mixture

sop for Temperature & Relative Humidity Monitoring

sop for Operation and Calibration of Heating Block

sop for Sterility Testing of Microbiology

sop for Disposal of Culture Media

sop for Drain point of Microbiology

sop for entry & exit procedure In Microbial limit test and Biosafety

sop for Gram Staining of Bacteria in Microbiology Laboratory

sop for Monitoring of Compressed Air/gases for microbiological analysis

sop for BET (Bacterial Endotoxin) test in Microbiology

sop for receipt storage and Determining the population of Biological indicators

sop for qualification of analyst microbiologist

sop for Bioburden test of Packing materials in Microbiology Laboratory

sop for microbiological assay of erythromycin antibiotic

sop for liquid particle counter

sop for operation and calibration of digital zone reader

sop for monitoring of ultraviolet efficiency LAF and pass box

microbiological assay of cyanocobalamin or vitamin B12

gowning procedure for microbiological testing area

swab testing of various surfaces for bioburden determination

sop for endotoxin challenge test

Hold time study protocol for sterilized media

sop for personnel Qualification protocol for aseptic area

sop for sampling and testing of drain water

Sop for Operation of Airborne Particle Counter

sop for Inoculum Preparation

sop for Validation protocol of steam sterilizer autoclave

sop for pathogen detection from drain point

Sop for Analysis of Raw water Purified water water for injection and pure steam water

sop for preservatives efficacy test

sop for collection and preservation of in house isolated microorganisms

sop for Operation Calibration and Maintenance of Micropipette

Sop for UV Efficacy Test

sop for gram staining

Sop for swab testing

sop for microbiological testing of water

PROCEDURE FOR FUMIGATION

sop for depyrogenation of apparatus

sop for media preparation

sop for fertility test growth promotion test of media

sop for Operation and cleaning of moist heat sterilizer

sop for monitoring by active air sampler

sop for swab sampling and testing for clean rooms in production area

sop for monitoring in microbiology laboratory

sop for Fumigation of aseptic area and microbiology lab

sop for monitoring of personnel in aseptic area

sop for maintenance of cultures

sop for Operation and cleaning of laminar bench

preparation of settle plates

sop for monitoring of pure steam

sop for entry and exit procedure to m.l.t and b.e.t room

sop for storage of and use of media

sop for disposal of microbiological media and cleaning of microbiological glassware

 

 

 

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