Self Inspection.docx

Healer Laboratories (Pvt) Ltd. 96/102C, S.I.E Kohat Road Peshawar Title:

Self Inspection

Department

QC/QA

Issue No.

01

1. Purpose This SOP ensure compliance with all relevant good manufacturing practices (GMP), Good Documentation Practices (GDP) and Regulatory requirements. 2. Scope This procedure is applicable to Self Inspection only. 3. Responsibility 3.1.

3.2.

3.3.

Management is responsible to developed and ensure a self-inspection program for monitoring and completion of corrective and preventive actions. Management is responsible to approve the self-inspection plan once developed, accept/reject any changes thereafter and to ensure proper implementation. Internal auditors will be nominated and assigned to self-inspection plans by site Management.

4. Procedure 4.1. 4.2.

4.3.

4.4. 4.5.

4.6. 4.7.

All self-inspection programs must be carried out in accordance with written procedures. The self-inspection program must include the requirement to define the plan, scope, timing, personnel involved, audit reporting, documentation of corrective action, timely follow-up and close-out. The scope of self-inspection program must encompass all GMP and GDP topics including information system and related quality management system controls (e.g. compliance with SOPs, the applicable QA system used, change control etc.). The sites self-inspection program must be periodically reassessed, in order to focus on areas of risk. Also the self-inspection program must take into account the need to review any recurrent quality system issues identified through non-conformance reporting (example: anomalies, deviations, OOS and complaints.). The self-inspection program must ensure regular inspection of all GMP and GDP areas and all topics must be cover at a minimum of every two years. The self-inspection program must include a mechanism for regular reporting of outstanding observation and corrective and preventive actions to the internal auditors and site Management.

Prepared By QC Analyst

Approved By QCM

Healer Laboratories (Pvt) Ltd. 96/102C, S.I.E Kohat Road Peshawar Title:

Self Inspection

Department

QC/QA

Issue No.

01

4.8. 4.9.

There must be routine Management review of the self-inspection program (progress observation and corrective and preventive action). On the completion of each self-inspection a written report must be issued documenting the details of the inspection.

Prepared By QC Analyst

Approved By QCM