To lay down the procedure to conduct the self inspection of the manufacturing facility of Active Pharmaceutical Ingredient and Drug Product.
1.0 PURPOSE
To lay down the procedure to conduct the self inspection of the manufacturing facility of Active Pharmaceutical Ingredient and Drug Product.
2.0 SCOPE
2.1 This procedure is applicable for carrying out the self-inspection of all Production, Quality Control, Quality Assurance, Warehouse & Engineering departments.
3.0 RESPONSIBILITY
3.1 Quality Assurance Department
3.2 Other Related Department
4.0 ACCOUNTABILITY
4.1 Manager - Quality Assurance
5.0 PROCEDURE
5.1 Self inspection is conducted in order to
5.1.1 Monitor the implementation and compliance with good Manufacturing practice principles.
5.1.2 To recommend necessary corrective measures.
5.1.3 To improve the awareness and responsibilities of personnel.
5.2 Self Inspection schedule:
5.2.1 Self Inspection schedule shall be prepared by Quality Assurance as per Annexure I and circulated to all concern departments.
5.2.2 Inspection frequency shall be once in a six month.
5.3 Inspection Responsibilities:
5.3.1 One inspection team shall be formed in each location containing minimum of three persons from Quality Assurance, Concern department and safety or Engineering.
5.3.2 Team shall conduct the inspection as per the respective checklist given in Annexure II to Annexure X.
5.3.3 Team shall make inspection report as given in Annexure XI to list the deficiencies observed and recommendations made during the inspection.
5.3.4 Team shall submit the inspection findings to the Head of concern department or location with in 3 working days for the implementation of discrepancies found during inspection.
5.3.5 The Head of the concern department or location shall prepare the compliance report as given in Annexure XII within 15 working days and submit the report to the Quality Assurance / Corporate Quality.
5.3.6 Inspection team shall review the compliance commitments.
5.3.7 Before starting the inspection, review the previous inspection findings & its action plan.
END OF DOCUMENT
Self inspection, quality assurance, drug product, pharmaceutical ingredient
