OBJECTIVE:
To lay down the procedure for handling and movement of standard weights.
SCOPE:
This SOP is applicable to the procedure for handling and movement of standard weights.
RESPONSIBILITY:
Initiator Executive/Designee: Production shall ensure the compliance of the SOP.
Initiator Officer/Designee: Production shall perform the operation activity as per SOP.
ACCOUNTABILITY:
QA Head shall be Accountable for implementation of SOP.
About Standard Weight:
In the pharmaceutical industry, standard weights are essential for ensuring the accuracy and consistency of drug products. These weights are used to calibrate weighing balances, which are critical for measuring the precise amounts of active pharmaceutical ingredients (APIs) and excipients used in the manufacturing process. Standard weights are typically made of high-quality materials, such as stainless steel or brass, and are available in a variety of sizes and classes of accuracy. They are regularly inspected and calibrated to maintain their accuracy and ensure compliance with regulatory standards.
PROCEDURE:
The standard weights shall be taken from the sieve area for calibration of balances.
The standard weight box shall be transferred near the balance for which calibration has to be done.
The outer surface of the standard weight box shall be wiped using dry lint free cloth.
The standard weights as per the calibration shall be placed on the balance.
The details of the calibration shall be recorded in the balance calibration record as per SOP
The standard weight box and the standard weights shall be cleaned using dry lint free cloth.
The standard weight shall be placed in the standard weight box and transferred to the sieve area.
The sieve area technician shall ensure cleanliness and the number of weight returned to the sieve area by concerned production / packing technician / executive.
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REFERENCES:
Not Applicable
ANNEXURES:
Not Applicable
ENCLOSURES: SOP Training Record.
DISTRIBUTION:
Controlled Copy No. 01 : Head Quality Assurance
Controlled Copy No. 02 : Head Production
Master Copy : Quality Assurance Department
ABBREVIATIONS:
| PD | : | Production |
| No. | : | Number |
| SOP | : | Standard Operating Procedure |
| IPQA | : | In process Quality Assurance |
REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To Be Written Manual |
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/handling-and-movement-of-standard-weights/