- OBJECTIVE:
To lay down a standard procedure to collect and store predecided sample quantity from each Raw material received for the formulation plant except acids, alkalies and solvents.
2.0 SCOPE:
This SOP is applicable to all Raw material received for formulation plant except acids, alkalies and solvents in Quality Control Laboratory
3.0 RESPONSIBILITY:
Officers / Executive – Quality Control shall be responsible for follow that procedure.
4.0 ACCOUNTABILITY:
Manager-Quality Control and Head QA Shall be accountable for compliance of this SOP.
5.0 ATTACHMENTS:
Nil
- PROCEDURE:
6.1 Collect required quantity of retain sample from Raw material received.
6.2 Take the sample in lain and black poly bag (in case if light sensitive material).
6.3 Keep this bag in air tight plastic container.
6.4 Place the label on container having details:
Retain Sample
Name of material
Batch no.
Quantity
Date
- No.
6.5 Enter the data in the retain sample register as per following:
Sr. No., AR.No., Name of raw material, batch no. Quantity of sample, date of preparation, storage condition, Box No. Sign.
6.6 Keep the plastic container in the box no. as specified in register.
6.7 Store the retain sample container for 10 years as pe list of storage condition available in QC department.
6.8 Destroy the retain samples after 10 years.
6.9 Prepare the list of RM to be destroyed and get approval for the same.
6.10 For destruction of retain samples soak the material in water or collect the liquid material and drain by flushing with excess water.
6.11 Preserve the destruction record for 5 years.
7.0 REFERENCES:
In-House
- ABBREVIATIONS:
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
9.0 DISTRIBUTION LIST:
Quality Assurance Department
Quality Control Department
10.0 HISTORY OF REVISION:
| Version No. | Date of Revision | Reason for Revision |
