OBJECTIVE:
To lay down the procedure for storage of dispensed raw materials.
SCOPE:
This SOP is applicable for storage of dispensed raw materials at {Company Name} {Location}..
RESPONSIBILITY:
- Initiator Officer/Designee: Production shall perform the operation activity as per SOP.
- Initiator Executive/Designee: Production shall ensure the compliance of the SOP.
ACCOUNTABILITY:
QA Head shall be Accountable for implementation of SOP.
About storage of material in Pharmaceutical:
Proper storage of dispensed raw materials is crucial in the pharmaceutical industry to maintain their quality, potency, and safety. Raw materials are sensitive to various factors like temperature, humidity, light, and contamination. Incorrect storage can lead to degradation, microbial growth, and loss of efficacy, potentially compromising the quality of the final product and endangering patient safety.
Key storage considerations include:
Proper labeling and documentation: Accurate labeling with clear identification and expiration dates, along with detailed storage records.
Temperature control: Maintaining appropriate temperature ranges (e.g., refrigerated, frozen) to prevent degradation.
Humidity control: Controlling humidity levels to prevent moisture absorption or loss, which can affect stability.
Light protection: Storing light-sensitive materials in amber-colored containers or in dark areas to prevent degradation.
Cleanliness and hygiene: Maintaining a clean and hygienic storage environment to prevent contamination.
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/storage-of-dispensed-raw-materials/
PROCEDURE:
The dispensed raw material shall be transferred from raw material hold of stores to the raw material hold of concerned production along with the material indent sheet.
Incase the dispensed raw material shall be transferred by using trolley, the material shall be stored in the raw material hold of concerned production by using a dedicated flexible physical barrier.
The empty hard gelatin capsules shall be stored in the empty capsule hold area.
The raw material shall be checked for proper physical integrity and intactness.
The attached Material issue tag of the raw material shall be identified and the weights shall be counter checked and the details shall be recorded in the weighing and checking record of BMR.
The Material issue tag shall be checked for the following details:
- Material Name
- Material Code
- Product Name
- Batch Number
- Batch Size
- Lot No.
- Bag No.
- Tare, net and gross weight
- UOM
- PART
- Created By
- Created On
- Printed By
- Printed On
The details of the temperature shall be recorded in the temperature and relative humidity record.
If any abnormality/Material Non-Conformance is observed while storage and transferring of the dispensed material, shall be initiated as per SOP and shall be investigated.
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 |
| MNC | : | Material Non-Conformance |
| No. | : | Number |
| SOP | : | Standard Operating Procedure |
| UOM | : | Unit Of Measurement |
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/storage-of-dispensed-raw-materials/