SOP on Internal Inspection Procedures
1.0 Purpose:
This SOP describes the self inspection method to ensure compliance with the GMP guidelines.
2.0 Scope:
This SOP applies to the inspection of all internal departments associated with the production & quality control along with the aim of continuous improvement a team of experts for Quality Audit shall be formed including experience senior staff of Production, Quality Assurance, Administration etc. and as per need experts from outside the company also may be included.
3.0 Responsibility:
3.1 The self audit team including Quality Assurance Manager shall ensure audit of the unit twice every year, documenting the inspection and preparing a written report with the recommendations and actions required for improvement for each department. The self inspection may additionally be performed in case of product recalls or repeated rejections.
3.2 It is the responsibility of each department to provide support to the Quality Audit team and to respond to any improvements / suggestions in the Quality Audit report within a predetermined time period after the receipt of the written audit report.
3.3 It is the responsibility of the Quality Assurance Manager or audit team to re-inspect to determine that the corrected action is satisfactory and to report these comments to Managing Director.
3.4 The Quality Assurance Manager is responsible to maintain all the records of internal inspections
4.0 Materials and Equipment: As required
5.0 Procedure:
5.1 Principle: Evaluation of systems, process and functions of a department to determine whether actions are required to improve compliance with the guidelines.
5.2 Preliminary:
5.2.1 Prepare a check list for internal inspection based on Schedule M of Drugs & Cosmetics Rules (15.3).
5.2.2 Review the earlier (internal or external) inspections, reports actions required, action taken and any comments that would indicate specific items to be inspected.
5.2.3 Set up schedule for each department for the date and time of the biannual inspection.
5.2.4 Unannounced inspection can be made at any time.
5.3 Audit: Prepare a report of the non-compliant items, and propose actions to be taken. Note especially critical problems such as breaches in procedures, or documents inadequate for traceability.