Standard Operating Procedure Title: VALIDATION OF ANALYTICAL METHOD

1.0 Purpose
1.1 It is established to assure quality in all aspects, and to avoid any unintentional contravention of Drug Act, cGMP and company standards.
2.0 Scope
2.1 It is applicable to all types of incoming and out going materials and all type of activities / process, conditions, equipment, documents, material and any “thing” (i.e. conditions, process, activity, material, equipment and document) which can affect quality directly or indirectly.
3.0 Responsibilities
3.1 Manager Quality Assurances.
3.2 Assistant Manager Quality Assurance.
3.3 Quality Assurance Officer.
4.0 Procedure
4.1. During the routine in process checks if any thing found to be in contravention of any requirements, regulations, system (which are well defined in SOPs, SMPs, and Product Specification) matter will be discussed with relative incharge / Departmental Head to remove that short coming.
4.2. If the production department takes no action on verbal intimation that particular thing will be “HOLD” by affixing red specified label of “HOLD” which means to stop that “thing” (already defined).as and where it is.

7. Precision: Reference Standard deviation calculation by 5 injection / reading of the same dilution should not be greater than 1%.
8. Accuracy of the Method: Different concentrations of active ingredient are mixed with the auxiliaries. The results should not differ by + 2 %.
9. Results are recorded by the Analyst in ledger and data is reviewed by the QC Manager.