Self-Inspection (Internal Audit)

1.0              OBJECTIVE

To lay down a procedure to evaluate the organizations compliance with GMP in all aspects of production and Quality control.

2.0              SCOPE

This SOP is applicable to all the operational departments, engaged in the manufacturing, packing, testing, holding and distribution of drug products.

3.0              RESPONSIBILITY

3.1             Department In-charge/Section In-charge:

3.1.1             To assist auditors during audit.

3.1.2             To fulfill the noncompliance noted during audit.

3.1.3             Reviewing of Inspection Report for effective follow up program.

3.1.4             Monitoring corrective actions and subsequent implementations.

3.1.5             Authorized Designee of QA:

3.1.6             To make internal audit schedule & Intimation to the department as per schedule

3.1.7             Head QA :

3.1.8             Selection of Self inspection Team

3.1.9             Approval of Internal audit schedule.

3.1.10         Reviewing of Inspection Report

3.1.11         Ensuring action plan and its compliance

3.2             Self - Inspection Team:

3.2.1             Lead Auditor:

3.2.2             Lead Auditor to lead the self-Inspection Team, execute the Self Inspection on the plan date and preparation of Self Inspection report.

3.2.3             Team Member:

3.2.4             Team member to support the lead Auditors for execution of self-inspection and report preparation.

3.2.5             Auditee:

3.2.6             To assist with the auditors at the time of self-inspection and comply with the Non-conformances reported by the Auditors.

3.2.7             Head Quality assurance:

3.2.8             Is responsible for planning, team selection, and execution of self-inspection and closing of self-inspection report.

4.0              SELF INSPECTION PROCEDURE

4.1             Definition: A systematic inspection program to detect any short comings in the implementation of cGMP and to recommend necessary corrective actions.

4.2             Self-inspections /Internal audits shall be conducted in order to:

4.2.1       To monitor the implementation and compliance with cGMP

4.2.2       To monitor the adherence to SOPs

4.2.3       To propose necessary corrective measures.

4.2.4       To improve the awareness and responsibilities of personnel.

4.2.5       To ensure the regulatory compliance with marketing authorization/ regulatory commitment.

4.3             Selection of Self inspection team:

4.3.1       Head- Quality Assurance: Select a Self-Inspection Team shall be a cross functional team from various departments such as Quality Assurance, Quality Control, Production, Store, Engineering and  Personnel & Administration department before the start of every calendar year (Last week of March).

4.3.2       Select the auditors in the self-inspection team based on their qualification, experience, expertise, technical skills and power of logical analysis.

4.3.3       Ensure that the Self Inspection Team is comprise of two members (at least but not limited to) and Head –QA or his authorized designee is the lead auditor. Refer Annexure-I “List of auditors”.

4.3.4       Ensure that the self-inspection team is comprised of lead auditors and team members. Lead auditors are specific based on their expertise in the different areas as identified by QA Head.

4.3.5       Ensure that Lead auditors/ Team members in the specific self-inspection team are not being of an Auditee department, where the self-inspection is planned.

4.4             Preparation of Self inspection schedule/ Planner:

4.4.1       Authorized Designee of QA: Prepare the yearly self-inspection schedule before the start of every calendar year (Last week of March), which includes all the functional departments such as Quality Assurance, Quality Control, Production, Store, Engineering, Personnel and Administration. Refer Annexure – II for “Self inspection schedule”.

4.4.2       Forward the yearly self-inspection schedule to Head QA for review and approval.

4.4.3       Head QA: Review and approve the Self inspection schedule.

4.4.4       Forward the approved self-inspection schedule to all the head of departments.

4.5             Planning of Self inspection:

4.5.1       Authorized designee of QA shall forward the filled Self Inspection Planning Form with all details e.g. audit date, auditors etc. to, One week prior to plan date of Self Inspection to HOD of Auditee department with marking of one copy to team members identified for self-inspection, identified for Self Inspection. (Refer Annexure – III Self Inspection Planning form).

4.5.2       Depending upon the work planning, head of concerned department may accept the planned self-inspection date or can propose another date for self-inspection, however the proposed date shall be within the same month and the same shall be verified by Head- Quality assurance.

4.6             Execution of Self Inspection:

4.6.1        A general Self inspection checklist as guidance is attached for the different department in Annexure -IV. Audit may be conducted by using guidance checklist during the audit and shall also perform based on the expertise of the auditor and current guidelines.  

4.6.2        Conduct the inspection & record all observations.  In case inspection is not completed in one day, continue on next day or any other agreed day.

4.6.3        During Self Inspection, relevant supporting documents shall be verified for compliance.

4.6.4        After the completion of self-inspection, all the team members shall discuss and finalize the deficiencies observed during the audit.

4.6.5        Formally detail the Non – conformance observed during the Self Inspection and discuss with the Auditee during Self Inspection closing meeting.

4.6.6        Mention the self-inspection execution date of different departments in Annexure-II.

4.7             Preparation of Self Inspection Report and Compliance report:

4.7.1        Self-Inspection Report shall be prepared within two days as per Annexure-V from the date of inspection and circulated to the concerned department head and record the same in the Self Inspection log book.

4.7.2        Respective department heads are responsible for preparing the Compliance Report for the deficiencies reported within a time frame of 7 days as per Annexure-VI from the receipt of self-inspection report and submit to Quality Assurance. The date of receipt of compliance report shall be recorded in Self Inspection Log Book. (Refer Annexure – VII, Self-Inspection Log Book).

4.7.3        Head -Quality Assurance or his authorized designee shall review and assess the compliance Report.

4.7.4        If compliance verification by QA representative is found satisfactory and all the non-conformances are closed by the Auditee department, authorized designee shall mention the closure date in compliance report as well as in self inspection log book.

4.7.5        Head - Quality Assurance shall finally prepare a Conclusion Report of Self Inspection department wise and send the conclusion report to CQA as per Annexure-VIII.

4.7.6        The conclusion report shall include a brief note on deficiency, the proposed corrective and preventive action, evaluation comments and recommendations.

4.7.7        A follow up inspection shall be sought by Head Quality Assurance or designee if needed to monitor the proposed corrective action and its implementation.

4.7.8        All self-inspection documentations are archived in Quality Assurance department

4.7.9        Keep all the self-inspection observation reports confidential as an internal system improvement which is strictly prohibited for external reviews.

4.8             Frequency of Self Inspection:

4.8.1        The frequency of self-inspection is scheduled as twice a year.

4.8.2        In case of any critical market compliant, product recall related to quality issue or critical GMP nonconformance e.g. Product mix ups, batch failure, self-inspection can be initiated in the respective areas/systems before the schedule.

4.8.3        In case of inspection or directions from regulatory agency.

4.8.4        Unscheduled inspections may be carried out at the direction of Head QA.

5.0              ANNEXURE(S)

                    Annexure –   I           List of auditor (Specimen Format)

                    Annexure --  II          Self inspection schedule  

                    Annexure –  III         Self Inspection Planning form

                    Annexure –  IV         Self Inspection Check List (Warehouse)

                    Annexure –  V           Self Inspection Check List (Engineering)

                    Annexure –  VI         Self Inspection Check List (Production Area)

                    Annexure –  VII        Self Inspection Check List (Personnel and Administration)

                    Annexure –  VIII      Self Inspection Check List (Quality Control)

                    Annexure – IX          Self Inspection Check List (Quality Assurance)

                    Annexure – X            Self Inspection Report (Specimen Format)

                    Annexure – XI          Self Inspection Compliance Report (Specimen Format)

                    Annexure – XII         Self Inspection Log Book

                    Annexure – XIII       Self Inspection Conclusion Report (Specimen Format)

6.0              DISTRIBUTED TO

Quality Assurance

7.0              ABBREVIATION(S)

GMP    : Good Manufacturing Practices

SOP     : Standard Operating Procedure

QA       : Quality Assurance

cGMP  : Current Good manufacturing Practices

            HOD    : Head of department

8.0              REFERENCES

EU GMP guideline, MHRA, Schedule-M (Point no. 15)

Quality assurance Pharma Volume-2

9.0              REVISION HISTORY

Revision No.	Change Control No.	Reason for the Modifications