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SOP for Personal Gowning Qualification

Objective
To establish a methodology for Personnel Qualification in the aseptic area of the Microbiology Section, Production (Aseptic area).

Scope
The scope is limited to evaluating the personnel entering the aseptic area, to ensure that their behavior, hygiene and operations are suitable for sterile manufacturing and to demonstrate that the qualified personnel are capable to consistently achieving desired sterility assurance for the finished product.

Purpose
The purpose of this activity is to demonstrate that the personnel entering the aseptic area, who are going to perform the sterile manufacturing process, aseptic practices, and manual operations during the production of Sterile Formulations, are qualified by giving training, evaluating and certifying to provide the desired Sterility Assurance in product manufacturing.

This qualification is also applicable to all the other personnel who are expected to enter the aseptic area for various other activities, like Microbiologists (for routine environment monitoring), Engineering Personnel (for maintenance purpose) and QA personnel (for supervision).

Responsibility

Quality control
  • To conduct the qualification study as per protocol.
  • To perform the microbiological monitoring.
  • Sampling as per protocol.
  • Preparation, review and compilation of the personnel qualification protocol.
  • Protocol training.

Quality assurance
Co-ordination with quality control, production and engineering to carryout personnel qualification activity.

Production
  • Review of the protocol.
  • Training of personnel.
  • To co-ordinate and support personnel qualification activity.


Engineering
  • Review of the protocol.
  • Training of personnel.
  • Co-ordination, execution and technical support in personnel qualification activity.

Requalification Criteria
Re-qualification will be performing in case of:
  • Personnel monitoring count observed out of limit.
  • If person return back after recovering from any disease.
  • Periodic requalification is also essential. This provides additional microbial information and helps to ensure consistent acceptability of gowning techniques employed. Typically, a one year requalification is sufficient if the monitoring data indicates the areas are in a state of microbial control.

Training Criteria
  • All the personnel involve in this activity shall be appropriately trained in their job related activities.
  • Verify the training records of persons involved in the personnel qualification activity.
  • All the persons who are supposed to enter the Aseptic area are required to the all training before execution of personnel qualification.
  • Only trained person shall be allowed for qualification activity for entering in aseptic area.

Qualification Pre requisites
  • All the persons who are supposed to enter the Aseptic area are required to the all training before execution of personnel qualification.
  • Only trained person shall be allowed for qualification activity for entering in aseptic area.
  • A person / operator shall undergo classroom training for, Aseptic techniques, behavior and working in the aseptic area and gowning procedures.
  • The personnel details for qualification shall be recorded in Personnel Identification.
  • The specific training topics for qualifying the entry into the Aseptic area for all the newly joined personnel’s are:
  1. Personnel Hygiene
  2. Entry & Exit of Aseptic Area of respective section.
  3. The gowning procedure of Aseptic Area of respective section.
  4. Cleaning & sanitation of Aseptic Area of respective section.
  5. Aseptic Practices in aseptic area
  6. Personnel monitoring procedure by contact plate & finger print.


Procedure and Methodology
  • Trainer shall demonstrate the proper gowning procedure for entry into the aseptic area as per respective SOP's.
  • QC (Microbiologist) shall give basic knowledge of microbiology to all the personnel who shall be involved in aseptic process and simulation test.
  • After a demonstration of gowning by QC, the personnel shall be asked to demonstrate the gowning procedure in the controlled area.
  • Those who are able to satisfy the gowning procedure shall only allow to aseptic area for personnel qualification.
  • Personnel shall be entering the Aseptic area as per respective SOP.
  • Qualified Microbiologist/IPQA shall observe whether the person is following the SOP for entry and gowning procedure and record the observations on Report.
Note: Microbiologist / IPQA shall perform the personnel monitoring during personnel qualification.


  • If the gowning is performed appropriately the personnel shall move to the Aseptic area, where they shall be monitored by a microbiologist for bioburden.
  • After completion of monitoring the personnel shall then exit from the aseptic area after disposing the garments.
  • The report of three days monitoring shall be attached with qualification report.
  • This personnel-monitoring procedure shall be repeated for 3 continuous working days.
Note: During the initial qualification the personnel shall be allowed to enter into the core working areas during these monitoring sessions.
  • However, in future any newly joined personnel shall not be allowed to enter the core areas during these monitoring sessions and he shall exit the aseptic area through exit Airlock.
  • After completion of all qualifications, final evaluation shall be prepared and recorded in qualification report.
  • After satisfactory result of 3 days’ personnel monitoring, only those persons are allowed to work in Aseptic area who has participated in media
  • Fill activity or has performed sterility activity in microbiology lab.
  • List of Authorized person for working in Aseptic area shall be prepared after successfully completion of personnel qualification.


Sampling Locations

Sr. No.

Location code

Location

Sampling method

1.

A

Forehead

 

 

 

 

Contact plate

2.

B

Chest right

3.

C

Chest left

4.

D

Right armpit

5.

E

Left armpit

6.

F

Right elbow

7.

G

Left elbow

8.

J

Right thigh

9.

K

Left thigh

10.

L

Right booty

11.

M

Left booty

12.

H

Right hand finger dab

Finger print

13.

I

Left hand finger dab




Acceptance Criteria
Person shall be considered qualified for entering into an aseptic area if:
  • Person performs satisfactorily during the gowning demonstration.
  • Personnel monitoring results of 3 continuous working days meet the acceptance criteria as per SOP.

Grade

Gloves

Personnel Gown

A

< 1

5

B

5

5



Non- compliance
  1. In case of any Non-compliance observed during PQ, inform to Head QA for necessary action.
  2. Document the details observed.
  3. The Head QA will study the impact of Noncompliance.
  4. If Noncompliance is acceptable and it does not have an impact on the performance of the Qualification, prepare final conclusion.

Deviations
  • In case of any deviation observed during PQ, inform to Head QA for necessary action.
  • Document the deviation detail in the observed deviation section.
  • The Head QA will study the impact of deviation. If deviation is acceptable and it does not have an Impact on performance of the Qualification, prepare final conclusion.

Change control
  • If any change control is required during PQ, inform to Head QA for necessary action.
  • Document the details observed.
  • The Head QA will study the impact of change. If change is acceptable and it does not have an Impact on performance of the Qualification, prepare final conclusion.


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