SOP Guide for Pharma

Test : SOP for Raw Material Receipt, Identification, and Storage for Lyophilized Products

SOP for Raw Material Receipt, Identification, and Storage for Lyophilized Products

Standard Operating Procedure for Handling Raw Materials for Lyophilized Products

1) Purpose

The purpose of this SOP is to define the procedure for the receipt, identification, and storage of raw materials required for lyophilized products. This SOP ensures the quality and integrity of the raw materials during storage and prior to usage in production, adhering to Good Manufacturing Practices (GMP).

2) Scope

This SOP applies to all personnel involved in receiving, identifying, and storing raw materials used in the manufacturing of lyophilized pharmaceutical products, including operators, warehouse staff, and quality assurance teams.

3) Responsibilities

4) Procedure

4.1 Receipt of Raw Materials

Upon receipt of raw materials, the following steps must be followed:

4.1.1 Inspection of Delivery

4.1.2 Verification and Identification

4.2 Storage of Raw Materials

4.2.1 Storage Conditions

4.2.2 Inventory Control

4.3 Handling and Movement of Raw Materials

4.3.1 Handling Procedures

4.3.2 Quarantine and Sampling

4.4 Documentation

All steps must be documented meticulously. The following documents should be filled out and verified at each stage:

5) Abbreviations, if any

6) Documents, if any

7) References, if any

8) SOP Version

Version 1.0

Annexure

Raw Material Receipt Logbook Template

Date Material Name Batch No. Supplier Quantity Receipt Condition Operator Initials QA Approval
DD/MM/YYYY Material Name Batch Number Supplier Name Quantity in kg/liters Good/Damaged Operator Name QA Initials
               

Material Identification and Labeling Record Template

Material Name Batch No. Receipt Date Label Generated Label Approved by QA Remarks
Material Name Batch Number DD/MM/YYYY Yes/No Yes/No Comments, if any
           


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