| Title: Weighing and Measuring Practices In Manufacturing Operations | |||||
| Guidance Number: 071 | |||||
| Prepared by: | Date: | Supersedes: | |||
| Checked by: | Date: | Date Issued: | |||
| Approved by: | Date: | Review Date: | |||
Weighing and Measuring Practices In Manufacturing Operations
Introduction
This document provides guidance in the weighing and measuring of materials used in the manufacture of drug products, active pharmaceutical ingredients (API), medical devices, and intermediates.
1. Physically Separated, Designated Area(s) should be used for weighing, subdividing, and dispensing materials.
2. When Materials are Exposed During Weighing and Measuring Operations, such operations should be performed in a manner designed to prevent cross contamination .
3. Environmental Conditions (e.g., Temperature, Relative Humidity, Lighting) in rooms or areas where materials are exposed during weighing or measuring should meet any specific environmental requirements applicable to the materials being weighed or measured.
4. Prior to Weighing Materials on a Scale or Balance, the operator should verify that the weighing device is clean, within calibration interval, and is working properly.
5. If Liquid Materials are to be charged to a vessel on a weight basis, the volume should be converted to weight using specific gravity. The calculation should be verified as correct by a second person, unless a validated computerized system is used to perform the calculation.
6. Methods for Measuring or Calculating Volumes of Liquids in Tanks include, but are not limited to, the following:
- Use of a clean and accurately calibrated stainless steel rod or ruler or a sight glass to measure the height of the liquid in the tank;
- Use of calibrated flow meter; or
- Use of calibrated weigh cells on load cells on the tanks.
7. Weight or Volume Measurement Accuracy should be established based on product and/or process requirements.
8. Personnel Training should include, but not be limited to, the following as applicable to the job function:
- Departmental SOP;
- Weighing and measuring methods; and
- Documentation practices.
9. Weighing and Measuring Operations should be included in the Manufacturing Batch Records for the product being manufactured. Documentation should include, and not be limited to, the following:
- Date(s);
- Identification of each batch material;
- Actual weights and measures of materials;
- Identification of the scales used to weigh the materials;
- Identification of person performing the weighing operation; and
- Identification of the second person who verified the weighing operation, unless a validated computerized system is used.
10. Material Inventory Records should be updated upon completion of the weighing operations to accurately reflect the quantity of material allocated to the manufacturing batch or lot and the quantity of material remaining in inventory.