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: