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Description of the Standard Operation Procedures - Operation, calibration and maintenance of electronic analytical single pan balances
The proper usage, calibration and maintenance of any analytical balances is a crucial important prerequisite following GMP compliance to generate meaningful analytical results. In the past but also today it is still a major area which will be visited during FDA inspections, which includes the weighing practices as such as well as the SOP describing these steps. On 11 pages this SOP (Standard Operating Procedure) guides you trough these processes and gives you in addition general GMP prerequisites to assure that Quality Control personnel performs the preparation, weighing, calibration and maintenance steps in accordance with the cGMPs. This SOP basically gives you all the necessary GMP guidance you need and can be used with only little company specific adoption.
Table of Content
1. Regulatory Basis, Reference Documents
4. Responsibilities and Accountabilities
4.1 Quality Control
4.2 Quality Assurance
5.2 Precautions and Interferences
5.3 Operation of balance
5.3.1 Balance Preparation
5.3.2 Sample preparation and precautions
5.4 Calibration Procedure
5.4.1 Volumetric calibration (pipette with water)
18.104.22.168 Calculation formula
5.4.2 Calibration by weights
Operation, calibration and maintenance of electronic analytical single pan balances
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