OBJECTIVE: To lay down the procedure for define the necessary action against the non-conformance of a product.

SCOPE: This procedure is applicable for information, investigation and control for any kind of non- conformance noticed or confirmed in Production, Stores on in others area for its proper investigation


Officer – IPQA shall be responsible for the implementation and compliance of the Standard Operating Procedure.

Officer/Executive-QA shall be responsible for the implementation and compliance of the Standard Operating Procedure.


Head- Quality Assurance shall be accountable for the implementation and compliance of the Standard Operating Procedure.

Head – Production shall be accountable for the implementation and compliance of the Standard

Operating Procedure.


Non-Conformance Report                                                                – Attachment-I


Whenever any non-conformance of procedure, result, activity observed with respect to the standards shall immediately bring to the notice of the concerned department Head and Head-Quality Assurance.

Non-conformance report shall be filled by the concerned Department officer with all details as per format.

After checking all the details filled in the form, Department – Head shall forward the same to Quality Assurance.

On receipt of the non-conformance intimation slip, Head- Quality Assurance shall take an early step to the non-conformance and will advise for the future course of action.

Head-Quality Assurance shall discuss and investigate the non-conformance observed in detail and ideal solution to the non-conformance shall be worked out and the same shall be written on the non-conformance report.

The corrective action and solution in detail to be filled by the Head-Quality Assurance and shall send to concerned Department for implementation.

Head-Quality Assurance or his nominee shall ensure that the action suggested is implemented correctly.

Concerned department shall write the details of the action taken on the non-conformance report and return the non-conformance report to Head-QA.

Head-Quality Assurance shall check that action suggested has been complied with and if satisfactory, the Quarantine status shall be lifted.


SOP  : Standard Operating Procedure

QA   : Quality Assurance


 Quality Assurance Department

Quality Control Department

Production (Formulation) Department

Production  (Packing) Department

Engineering & Utility Department

Warehouse Department


Revision No. Date of Revision Reason for Revision
00  New SOP

A 5 -

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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