Evaluation of performance of the Aseptic Processing Area core operators/Microbiologists

1.0 OBJECTIVE

1.1To lay down a procedure for evaluating the performance of Aseptic Processing Area core operators / Microbiologist.

2.0 SCOPE          

2.1The Scope of this procedure is limited to evaluate the performance of Aseptic Processing Area core operators / Microbiologist at Company.

3.0 RESPONSIBILITY 

3.1 Incharge – Audit & Compliance

4.0 ACCOUNTABILITY         

4.1 Head QA

5.0 PROCEDURE

5.1 Before any individual is allowed to carryout any operations, the individuals must complete their training as per the SOP.

5.2 Once the training activity is completed, QA shall conduct an objective assessment of the operator’s knowledge, skills towards the Aseptic Techniques, Clean room behavior, gowning, and adherence to SOPs. 

5.3 QA shall assess the effectiveness of training by conducting documented assessments in the work place to demonstrate how effectively training is transferred into practice. Assessment methods can vary and shall include direct observation of a task, simulation and an interview.

5.4  QA shall evaluate the effectiveness of the training and adherence to the approved procedures for the APA operators/microbiologist every month.

5.5 Assessment Procedure:

5.5.1 QA Representative shall conduct this assessment without giving any prior intimation.

5.5.2 QA Representative shall conduct this assessment by using pre-determined checklists. Those check lists are extracted from the respective standard operating procedures.

Following are the operations subjected for the assessment

·Operators Gowning Procedure

·Operators Aseptic Techniques

·Operators Clean room behaviour

·Adherence to SOPs

5.6 Operators Gowning Procedure:

5.6.1  A qualified Microbiologist shall perform this activity by using a pre-determined checklist. The checklist is enclosed as an “Annexure-I”. This activity shall be performed along with the “Gowning Validation” activity by taking swabs for microbiological evaluation.

5.6.2 As per the pre-determined checklist Microbiologist shall assess the operator’s performance towards the gowning procedure.

5.6.3 If the operator’s performance is not satisfactory, then Head-QA shall initiate a re-training programme for the operator or a decision for immediate removal of the operator from the specific function in that order will be taken.

5.6.4 Upon satisfactory evaluation, the operator shall be allowed to work in the Aseptic Processing Area under the supervision of the production supervisor.

5.6.5 Record the results in the “Annexure-I”. QA shall also consider the operators gowning validation results while evaluating the Operators/Microbiologist performance.

5.7  Operators Aseptic Techniques:

5.7.1  A qualified Microbiologist / QA representative shall perform this activity by using a pre-determined checklist. The checklist is enclosed as an “Annexure-II”.

5.7.2  As per the pre-determined checklist Microbiologist / QA representative shall assess the operators performance towards the operators aseptic techniques.

5.7.3  If the operator’s performance is not satisfactory then Head-QA shall initiate a re-training programme for the operator or a decision for immediate removal of the operator from the specific function in that order will be taken.

5.7.4 Upon satisfactory evaluation the operator shall be allowed to work in the Aseptic Processing Area under the supervision of the production supervisor.

5.7.5  Record the results in the “Annexure-II”. QA shall also consider the results of personnel swabs while evaluating the Operators/ Microbiologist aseptic techniques.

5.8 Operators Clean room behavior

5.8.1 A qualified Microbiologist/ QA representative shall perform this activity by using a pre-determined checklist. The checklist is enclosed as an “Annexure-II”.

5.8.1 As per the pre-determined checklist Microbiologist/QA representative shall assess the operator’s performance towards the operators Clean room behaviors.

5.8.2 If the operator’s performance is not satisfactory then Head-QA shall initiate a re-training programme for the operator or a decision for immediate removal of the operator from the specific function in that order will be taken.

5.8.3 Upon satisfactory evaluation, the operator shall be allowed to work in the Aseptic Processing Area under the supervision of the production supervisor.

5.8.4 Record the results in the “Annexure-II”. QA shall also consider the operators gowning validation results while evaluating the Operators/Microbiologist performance.

5.9 Adhering to the SOPs

5.9.1 A qualified Microbiologist/ QA representative shall perform this activity by using a pre-determined checklist. The checklist is enclosed as an “Annexure-II”.

5.9.2 As per the pre-determined checklist Microbiologist/QA representative shall assess the operator’s performance towards the adhering of the approved SOPs.

5.9.3 If the operator’s performance is not satisfactory then Head-QA shall initiate a re-training programme for the operator or a decision for immediate removal of the operator from the specific function in that order will be taken.

5.9.4 Upon satisfactory evaluation the operator shall be allowed to work in the Aseptic Processing Area under the supervision of the production supervisor

Note:  Every operator should have participated in Aseptic Media fills by functioning as per the normal operation like aseptic connections, replenishment of closures, clearing the line jams etc., before the operator is engaged for the Aseptic operations.  In addition, the operator has to be re-qualified at least annually through the aseptic media fills.

C Frequency of evaluation for core operators is on monthly basis.

6.0 ANNEXURES

6.1 Operators / Microbiologist Gowning Procedure Check List -Annexure-I

6.2 Personnel Behavior in the APA Check List-Annexure-II