SELF INSPECTION - SOP

1.0
PURPOSE :
To lay down a procedure to describe the steps to be followed for self inspection in Order to evaluate the compliance with GMP in all aspects of production and Quality control and to propose necessary corrective measures.
2.0 SCOPE:
This Standard Operating Procedure applicable to Ware house, Manufacturing, Engineering, Quality Assurance, Quality Control, Personnel.
3.0 RESPONSIBILITY:
General Manager - Quality Assurance
4.0 ACCOUNTABILITY:
President - Technical
5.0 DEFINITION: Nil
6.0 PROCEDURE:
6.1 Self Inspection Team
6.1.1 Self Inspection Team comprises of following:
• QA Head
• Unit Head
• Engineering Head
• R&D Head
6.2 Conduct self inspection for the following departments as per schedule :
• Tablet
• HG Capsule/ SG Capsule.
• Parental / Liquid Oral
• Engineering.
• Warehouse
• QA/QC
• Personnel
6.3 Frequency of self-inspection
6.3.1 Self-inspection will be conducted once in six month for each department for whole one day or more, if required.
6.4 Audit shall be conducted in shifts, if production is performed in the 2nd and 3rd shifts.
6.5 Use department wise checklist during self-Inspection (Refer Annexure1 to 10) Specific observation must be noted down during the audit.
6.6 Self - inspection team must prepare final report mentioning their observation Shortcomings, non- compliance’s on completion of self-inspection. These observations shall be classified as
1. Critical : A non – compliance that directly affects the product
2. Major : A non – compliance that may affect the product.
3. Minor : A non- compliance that does not directly affect the product.
6.7 Inform non- compliance’s to the concerned department head.
6.8 Department Head must respond in writing to each point within15 days with his response and suitable corrective action plan.
6.9 Self –inspection team reviews the responses to each non–conformance for appropriateness and carry out follow up activities (Conduct re-audit, if required) to ensure that all the non-conformances are closed off .A follow-up report shall be prepared.
6.10 Self-Inspection may also be conducted on special occasion’s e.g. in the case of Repeated market complaints, repeated rejection or product recalls.
6.11 Self- inspection may be carried out for the whole plant with specific focus e.g. House keeping, documents etc.
6.12 A log of all audits shall be maintained. Refer annexure 11 “QA Audit Log” (FM/QA/090)
6.13 Archive the self- inspection documents for 5 years
7.0 REFERENCE: Nil
8.0 ENCLOSURES :
8.1 Annexure – I : Check list for Tablet
8.2 Annexure – II : Check list for HG Capsule
8.3 Annexure – III : Check list for SG Capsule
8.4 Annexure – IV : Check list for Quality Control
8.5 Annexure – V : Check list for Quality Assurance
8.6 Annexure – VI : Check list for Warehouse/Central pharmacy
8.7 Annexure – VII : Check list for Engineering
8.8 Annexure – VIII : Checklist for Personnel
8.9 Annexure – IX : Quality Assurance Audit Log
(User of this documents should prepare all the above check lists)
9.0 ABBREVIATIONS:
9.1 HG : Hard Gelatin
9.2 SG : Soft Gelatin
9.3 GMP : Good Manufacturing Practice