sop for retesting for raw materials

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3 hours ago

sop for retesting for raw materials

1.0 Purpose
1.1 To describe a procedure for Re-Testing for Raw Materials (active and excipients)

2.0 Scope
2.1 This procedure is applicable for Re-Testing for Raw Materials located at Quality control department at ABC Pvt. Ltd.

3.0 Responsibility
Officer QC/ Executive QC Preparation of SOP and follow the procedure as per SOP
Assistant Manager Reviewing and Training of SOP
Manager QC Implementation of SOP
4.0 Accountability
4.1 Manager Quality Control is accountable for implementation and compliance with SOP.

5.0 Procedure
5.1 All the raw materials shall be re-tested after 1 year from the date of approval.
5.2 In case of product having short expiry with comparison to retest date then retest date will

be remain as NA (Not Applicable).
5.3 Date of re-test shall be mentioned on the “Approved label” pasted on the approved raw materials.

Without re-testing and re-approval from Quality control department, the raw material shall

not be issued by store department.
5.4 Active raw materials and excipients shall be re-tested till the expiry or 03 years whichever is earlier before.
5.5 The list of the raw materials, due for re-testing, in a month are printed from the Store department.
5.6 The Officer / Executive QA shall ensure that the respective raw material shall be sampled, tested

and released due for re-testing.
5.7 The raw materials (to be re-tested) shall be sampled as per sampling SOP No. QCD-013.
5.8 The raw material shall be tested for parameters like description, assay as per their current STP,

and related substances and any other specific test.
5.9 If material conforms to the specification approval shall be given and “Approved” label shall be

pasted on material. Blocked materials shall then be un-blocked by the Store personnel.
5.10 A suffix ‘R” is added to the existing AR No. to identify it as a re-test material. However, for dispensing

purpose the original AR No. shall remain intact.
5.11 In case material does not conform to the specification, the material shall be rejected, and the

Store department shall be informed.
5.12 Paste the “Rejected” label on rejected material, and ensure that material is shifted from approve area to rejected area.

6.0 Reference
In house specification

7.0 Attachments
Not Applicable

8.0 Distribution
Distribution of the controlled copy to concerned departments.
Additional copies may be issued for specific purpose.

9.0 Abbreviations
QA : Quality Assurance
QC : Quality Control
SOP : Standard Operating Procedure
A.R. : Analytical Report
STP : Standard Testing Procedure

10.0 Revision History