Self Inspection SOP

SOP for self inspection in pharmaceuticals | Self-inspection checklist | GMP self inspection checklist |

Self Inspection SOP covers below points:
- Self-inspection definition
- Self-inspection schedule
- Self-inspection team
- Preparation for the Self-inspection
- Conducting the Self-inspection
- Self inspection calendar
- Self inspection checklist

1.0 OBJECTIVE :

To describe a procedure for planning, execution and recording of Self Inspection to ascertain the status of GMP implementation and to recommend necessary corrective action for their non-recurrence.

2.0 SCOPE :

This SOP is applicable for the Self Inspection in all operational departments.

3.0 RESPONSIBILITY :

Quality Assurance Officer and Above along with Concerned Department Head.

4.0 ACCOUNTABILITY:

Q.A. Head

5.0 PROCEDURE :

5.1 Self-inspection: A planned and systematic examination and check of a system, procedure or operation by Self-inspection in order to monitor compliance, the effectiveness of established standards, and to allow for improvement and corrective measures wherever required.

5.2 Self-inspection is to be carried out twice in a year by the self-inspection team in the operational department viz. Production, Quality Assurance, Quality Control, Warehouse, Human Resource (including Housekeeping) and Engineering. It may also be carried out in case of the repeated failures in the procedures, product recall etc.

5.3 Self-inspection team include two to three senior officials, excluding the Auditee department. However Department Head or his/her designee must take part in the Self inspection.

Head – Quality Assurance
Head-Production
Head-Quality Control
Head-Engineering
Any other person, if required.

5.4 The Quality Assurance Head is to prepare a Self- Inspection plan and distribute it one week advance to all the concerned department heads. The Self- Inspection plan shall declare the departments to be inspected and the team members from the self-inspection team, which shall be conducting the inspection.

5.5 Any amendment in the self inspection plan/ schedule is to circulated to the Auditee and auditors.

5.6 Self-Inspection team, as per the self-inspection plan, performs the inspection along with concerned department head or his nominee in his absence.

5.7 Self-inspection schedule

Self-inspection team is carry out periodic inspection in all the operational departments.
Departments include (as applicable) Warehouse, Production, Quality Control, Engineering, Human Resource and Quality Assurance.
Self-inspection schedule is prepared for the each operational department, so as to cover each department at least twice in a year and every month one department will covered.
Additional self-inspection may be carried out in special circumstances but not limited to:
- Product recall
- Repeated Product failures
- Serious market complaints

5.8 SELF-INSPECTION TEAM

Quality Assurance officer or above is indispensible member of self-inspection team from cross-functional areas.
For a given departmental Inspection, cross-functional team is exclude the representative from the Auditee department.
The Head of the department or authorized nominee, of the respective department is the Auditee for his/her department.
Representative from other than Quality Assurance will audit the Quality Assurance department.

5.9 PREPARATION FOR THE SELF-INSPECTION

Checklist for inspection is prepared by Quality Assurance Head in consultation with Heads of cross functional department & will be circulated to all auditors.
Self Inspection is carried out to cover following disciplines with respect to GMP:
- Personnel
- Premises including personal facilities
- Maintenance of building and equipment
- Storage of starting material and finished products
- Equipment & Machinery
- Production & in process control
- Quality Control
- Documentation
- Sanitation and hygiene
- Validation and revalidation programme
- Calibration of instruments & measurement system
- Recall Procedure
- Complaint management
- Label control
- Result of previous self inspection and any corrective action taken

5.10 CONDUCTING THE SELF- INSPECTION:

Prior to commencing the Inspection the auditor is to inform the departmental head or supervisor, where possible of the function to be inspected and scope for recognition of the inspection start.
The Inspection is then commence within and above function to be Inspected with reference to the procedure, work instructions, records, and previous Inspection reports. Observe, examine and record objectively non conformance, specific details, conditions etc.
The self-inspection team is take the help of the ‘Inspection checklist’ however the inspection observations may not be limited to the checklist.
The auditors is record the non-conformance/ deviations, observations and area of improvements.
The categorization of Critical, Major and Minor observation is based on the following guidelines.
- Critical Observation defined as any observation, which may cause significant effect on the strength, identity, purity and safety of the product and may have an adverse physiological response to the consumer.
- Major observation is defined as any observation, which has produced or may produce a product that does not comply with its marketing authorization, a major deviation from the manufacturing license or GMP approval.
- Any observation that has no direct influence on product quality is defined as Minor observation.
- Categorizations of observations are based on the assessed risk level and may vary depending on the nature of the products manufactured. In some circumstances, an example of major deficiency as mentioned above may be categorized as critical.
After completion of Inspection, the auditor(s) is conduct sum up meeting with concerned HOD or designee (Auditee).
All the Self-Inspection findings of the respective department is reported and submitted in the form of “Self-inspection Report”.
Upon completion of the Inspection Auditor is immediately fill the “Self-inspection Report” & send a copy of the same to Q.A. Head the same day of Inspection. Auditor raise the non conformance report with objective evidences detailing deviation from the quality system approved procedure and other formally approved work practices. These deviations is considered as justifiable non conformance. The Non Conformance Report is distributed to concerned persons by the auditor within a weak time.
Non Conformity & Corrective Action
- Upon receipt of Self-inspection report, the Auditee is prepare agreed action plan in coordination with the Q.A. Head or designee and define time lines for corrective and preventive measures.
- The Head of the Inspected department is responsible for the corrective and preventive actions for observations made during the Internal Audit.
- Auditee submit the action plan to Q.A. Head in the same self-inspection report within three working days.
- Q.A. Head or designee follow up with the concerned HOD to correct the deficiencies within the time line unless otherwise justified.
CLOSING OF AUDIT REPORT
- Auditee take the corrective action on or before agreed date & confirm it in inspection report.
- Auditor verify that the corrective action is taken and implemented.
- The auditor send copies of Non conformity & corrective action report to Q.A. Head and keep a copy with them.
- Q.A. Head when satisfied close the Non conformity.
- Q.A. Head prepare Clause wise Analysis of Non conformities raised during each self inspection.
- Q.A. Head will send the confidential report to Vice President Technical.

6.0 ABBREVIATIONS:

Abbreviation	Expanded form
SOP	Standard Operating Procedure
Q.A.	Quality Assurance
HOD	Head of the department
GMP	Good Manufacturing Practices

7.0 ANNEXURES:

Annexure No.	Title
01	Appointment of self inspection team
02	Self inspection calendar
03	Self inspection checklist
04	Non compliance report
05	Compliance status for audit
06	Self Inspection Log Book