SOP Guide for Pharma

SOP for SOP for Raw Material Receipt, Identification,…

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

Blending Process Logbook Template

Date Time Operator Initials Blending Duration Remarks
DD/MM/YYYY HH:MM Operator Name Duration in minutes Process completed as per SOP
         

Batch Manufacturing Record (BMR) Template

Batch No. Start Date End Date Blending Equipment Operator Initials Supervisor Signature
Batch Number DD/MM/YYYY DD/MM/YYYY Equipment Name Operator Name Supervisor Name
           


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