Procedure For Storage and maintenance of raw material control sample
1.0 Objective
To define a procedure for Storage and maintenance of raw material control sample.
2.0 Scope
Raw Material Control Sample retained in Quality Control Laboratory at abc Pvt. Ltd.
3.0 Responsibility
3.1 Executive – Quality Control.
3.2 In charge/Head-Quality Control.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QC : Quality Control
CC NO : Change Control Number
cGMP : Current Good Manufacturing Practice
G : General
5.0 Procedure
5.1 Control Sample of every raw material received and collected at the time of sampling
in a Quantity sufficient to carry out all tests twice, except sterility / Bacterial End toxin
shall be kept in appropriate amber coloured glass bottles securely closed.
5.2 Sample of corrosive substance like strong acids, ammonia will not be kept as control samples.
5.3 Every container will be labeled with name G.R.N. No., Batch No., Mfg. Date and Exp. Date,
wherever available, Laboratory reference No. date of sampling and the signature of the sampler.
5.4 The control sample should be stored in the corrugated box month wise in the control sample
room and the entry should be made in the register meant for raw material retain sample.
5.5 The control sample should be store for one year after the expiry of the sample.
5.6 After one year from the expiry of sample, the control samples will be destroyed.
6.0 Forms and Records
6.1 None.
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Assurance, Quality Control
8.0 History
| Revision Number | Details For Change |
Reason for Revision |
| 00 | New SOP | NA |
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Procedure For Storage and maintenance of raw material control sample