1.0 Purpose: 1.1 The purpose of this SOP is to implement system storage and labeling of raw and packing materials in raw material stores.
2.0 Scope: 2.1 This SOP is applicable to all raw materials; packaging material is used for manufacturing at the Pharmaceutical plant.
3.1 HOD Quality Assurance is responsible for the implementation of this procedure.
4.1 Raw material and packing material will be purchased only from the approved supplier.
4.2 The approved raw material and packing material will be placed in the respective places in the raw material stores. The packing material for primary packing will be kept in double wraps to prevent that from contamination.
4.3 The approved material will be kept on the respective shelves as per the size and type of material without intermixing two batches of the same material.
Division of area or identification storage and labeling of raw and packing materials:
Green– For approved materials, Yellow– for Under test materials, and Red– for Rejected materials.
5.4 The identification area with colored plate will be displayed with material with the following details:
5.4.2 Date of Receipt
5.4.4 Lot Number
5.4.6 Acceptance A.R. Number
5.5 Intermixing of different lots and materials is prevented by keeping them in separate bundles.
5.6 The returned materials from the production are put together in the same bundle from which the original material was issued, and if the same lot number does not exist, it is kept with a separate identification plate.
6.1 All the documents in use must be duly approved and controlled prior to issue to the user department.
6.2 Obsolete documents shall be removed immediately from the point of use.
7.1 Issuance record
8.1 Master Copy file
8.2 Controlled Copy File
8.3 Head of the respective departments.
9.1 Requirement of ISO 13485:2016, MDD 93/42/EEC, IMDR 2017.