5.1 Preparing the Self Inspection Plan: 
5.1.1 A self-inspection plan shall be prepared at least one week prior to the first Self -Inspection plan for that year by QA personnel by ensuring that each department is inspected at least once in six months.
5.1.2 Frequency shall depend upon complexity of the operation and previous inspection results.
5.1.3 Self-inspection plan shall be approved by Head QA / designee as per Annexure-I. Planed month shall be marked as “X” during preparation of yearly plan.
5.1.4 On the basis of yearly plan, QA personnel shall prepare monthly self-inspection plan. The monthly plan shall be circulated to concerned department Head and to auditor(s) at least one weak prior to the scheduled date. Head QA or designee shall approve the self-inspection plan monthly as per Annexure-II.
5.1.5 Suitably trained employee shall conduct the inspection of the function controlled by Head QA.
5.1.6 Where serious deficiencies of the quality system become apparent at any time during routine operations an immediate inspection shall be carried out for which no formal intimation is required.
5.1.7 Scheduled and Unscheduled inspection will be noted on the self-inspection schedule log as per Annexure-III and inspection reports are issued.
5.1.8 Self-inspection shall be performed in case of critical market complaint, product recall or repeated rejections.
5.2 Selection of Auditor(s):
5.2.1 The auditor(s) are selected on the basis of qualification and experience. Minimum qualification for the auditors shall be employee with university graduation/Diploma and five-year experience in industry.
5.2.2 Auditors shall have a sound knowledge of cGMP, Quality system, SOP’s, material and product standards apart from relevant experience and qualification
5.2.3 List of the auditors shall be prepared by Manager QA or Designee as per Annexure- IV.
5.2.4 Head QA or Designee shall constitute the internal audit team from cross- functional areas comprising of at least two members.
5.2.5 Head QA shall consider as lead auditor for auditing all departments except QA department. For QA department senior auditor from the cross-functional department shall be considered as a lead auditor.
5.3 Conducting the Self Inspection:
5.3.1 The auditor(s) shall explain the scope and nature of inspection to the auditee.
5.3.2 The inspection will then commence within and above the function to be inspected with reference the quality manual procedures, SOPs, cGMP norms, records, previous inspection reports.
5.3.3 Auditor(s) shall audit based on Audit checklist.
5.3.4 If any point in checklist is not applicable during self-inspection shall be clearly justified with reason for not applicable.
5.3.5 Auditor shall observe for any deviations from standard operating procedures. In case any noncompliance observed with respect to the laid down procedure, the same shall be recorded. Internal audit observation report shall be prepared as per the Annexure-V by the auditor.
5.3.6 The audit observations shall be categorized as Critical, Major and Minor observation based on the following guidelines.
5.3.6.1 Critical Observation: These observations require immediate actions. The observed condition will seriously affect the quality of the product, violates essential requirements and quality assurance practices and effects regulatory compliance.
5.3.6.2 These Observations that has a significant impact on quality and/or safety of the final product.
5.3.6.3 Major Observations: The observation documents a clear non-compliance with the relevant requirements and quality assurance practices. An action to be taken with a high priority is recommended.
5.3.6.4 These Observations are impact on quality of the product, but does not make any significant change in the final quality of the product.
5.3.6.5 Minor Observation: These observations may not necessarily affect the quality of the product but is still a violation of the relevant requirements, but does not constitute a clear out of compliance status. Actions should be taken within a reasonable timeframe.
5.3.6.6 These Observations does not affect the any impact on the quality of the product and operating system.
5.3.7 Any observation that has no direct influence on product quality shall be defined as minor observation.
5.3.8 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.
5.3.9 The Audit response report as per Annexure-VI shall be issued to concerned auditee.
5.3.10 Audit response shall be filled by the Auditee/Department Head mentioning the target date for completion of the audit response report as per Annexure-VI.
5.3.11 Department Head shall mention the person(s) responsible for completion of proposed corrective and preventive action under responsibility column of Annexure-VI.
5.3.12 Auditee shall submit the completed Audit response to auditors within 30 working days from receipt of Audit Observation Reports from auditors.
5.4 Closure:
5.4.1 Department head shall comment on the closure of the audit response with verification of compliance status as closed or not closed and date of completion and same shall be forwarded to auditors.
5.4.2 The auditors shall verify the compliance with written procedures and completeness of the documents in the respective department/ area.
5.4.3 Auditor(s) shall verify the completion of corrective and preventive action and shall forward the form to QA Head or designee for closure.
5.4.4 Incase if any of the observations cited are categorized as CRITICAL or MAJOR, same should be physically verified by the auditor.
5.4.5 For minor observations, the report can be closed based on written response and shall be verified during the next physical inspection of the concerned department.
5.4.6 Incase if any of the proposed action are not completed same shall be justified by Head of Department/Designee and comments from Head QA /Designee shall be obtained for the same.
5.4.7 The status of self-inspection and Audit response for the present month shall be briefed to the management through Management Review Meeting.
5.4.8 Annually once self-inspection findings shall be reviewed and repeated observations if any must be rectified through CAPA procedure.