SOP Guide for Pharma

Test : SOP for Weighing and Dispensing of Raw Materials for Lyophilization

SOP for Weighing and Dispensing of Raw Materials for Lyophilization

Standard Operating Procedure for Weighing and Dispensing of Raw Materials for Lyophilization

1) Purpose

The purpose of this SOP is to establish the process for weighing and dispensing raw materials used in lyophilized product formulations, ensuring accuracy, consistency, and traceability of material usage as per Good Manufacturing Practices (GMP).

2) Scope

This SOP applies to the operators, quality control, and warehouse staff responsible for weighing and dispensing raw materials required in the lyophilization process, from receipt to production usage.

3) Responsibilities

4) Procedure

4.1 Preparation for Weighing

The following steps are to be performed before the weighing process begins:

4.1.1 Material and Equipment Setup

4.1.2 Raw Material Retrieval

4.2 Weighing Process

4.2.1 Weighing Procedure

4.2.2 Cross-Verification

4.3 Dispensing Process

4.3.1 Dispensing to Production

4.3.2 Documentation and Labeling

4.4 Cleaning and Storage Post-Dispensing

Following the dispensing process, the weighing and dispensing area should be cleaned and materials stored as follows:

5) Abbreviations, if any

6) Documents, if any

7) References, if any

8) SOP Version

Version 1.0

Annexure

Weighing Logbook Template

Date Material Name Batch No. Required Weight Actual Weight Operator Initials QA Verification
DD/MM/YYYY Material Name Batch Number Weight in grams/kg Weight in grams/kg Operator Name QA Initials
             

Dispensing Logbook Template

Date Material Name Batch No. Dispensed Quantity Production Batch No. Operator Initials QA Verification
DD/MM/YYYY Material Name Batch Number Quantity in grams/kg Production Batch Number Operator Name QA Initials
             


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