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 of consistently achieving desired sterility assurance for the finished product.

Purpose

The purpose of this activity is to demonstrate that the person entering the aseptic area, who is going to perform the sterile manufacturing process, aseptic practices, and manual operations during the production of Sterile Formulations, is 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 purposes), and QA personnel (for supervision).

Responsibility

Quality control

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

Quality assurance

Coordination with quality control, production, and engineering to carry out personnel qualification activity.

Production

• Review of the protocol.
• Training of personnel.
• Coordinate and support personnel qualification activity.

Engineering

• Review of the protocol.
• Training of personnel.
• Coordination, execution, and technical support in personnel qualification activity.

Requalification Criteria

Re-qualification will be performed in the case of:

• Personnel monitoring count observed out of limit.
• If a person returns 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 involved 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 all training before execution of personnel qualification.
• Only trained persons shall be allowed for qualification activity for entering an aseptic area.

Qualification Pre requisites

• All the persons who are supposed to enter the Aseptic area are required to all training before execution of personnel qualification.
• Only trained persons shall be allowed for qualification activity for entering an aseptic area.
• A person/operator shall undergo classroom training for, Aseptic techniques, behavior 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 are:

1. Personnel Hygiene
2. Entry and exit of the Aseptic Area of the respective section.
3. The gowning procedure of the Aseptic Area of the respective section.
4. Cleaning & sanitation of the Aseptic Area of the respective section.
5. Aseptic Practices in aseptic area
6. Personnel monitoring procedure by contact plate & fingerprint.

Procedure and Methodology

• The trainer shall demonstrate the proper gowning procedure for entry into the aseptic area as per respective SOPs.
• QC (Microbiologist) shall give basic knowledge of microbiology to all the personnel who shall be involved in the 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 be allowed to aseptic areas 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 the Report.

Note: Microbiologist / IPQA shall perform the personnel monitoring during personnel qualification.

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• 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 of the garments.
• The report of three days of monitoring shall be attached with the 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 the future, any newly joined personnel shall not be allowed to enter the core areas during these monitoring sessions and they shall exit the aseptic area through exit Airlock.
• After completion of all qualifications, the final evaluation shall be prepared and recorded in the qualification report.
• After a satisfactory result of 3 days’ of 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 the microbiology lab.
• A list of Authorized persons for working in the Aseptic area shall be prepared after the successful 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	Fingerprint
13.	I	Left-hand finger dab

Acceptance Criteria

A person shall be considered qualified for entering into an aseptic area if:

• A 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 does not have an impact on the performance of the Qualification, prepare the 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 the deviation is acceptable and does not have an impact on the performance of the Qualification, prepare the 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 the change is acceptable and does not have an impact on the performance of the Qualification, prepare the final conclusion.

Annexure

Nil

Revision History

Nil

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