Doc No: SOP 12

Revision No: 1
Revision Date:

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SECTION TITLE: STANDARD OPERATING PROCEDURES Approved By

DOCUMENT TITLE:
QA RAW MATERIAL RECEIVING Pages: 2
INSPECTIONS

PURPOSE: This SOP describes the procedure for the sampling & evaluating received raw
materials

PERSON MONITORING
FREQUENCY CORRECTIVE ACTIONS RECORDS
RESPONSIBLE ACTIVITY
When findings deviate from written
standards the QA designate will
document findings on the Daily / Monthly
Daily GMP GMP Audit Form and notify the General
Daily GMP Audit,
Audit Manager of the deviation.
Monthly GMP
According to QA Monthly GMP
Audit,
QA Designate Audit Schedule, Audit, QA Raw Short term action will be initiated and
QA Raw Material
As Required material recorded on the Daily / Monthly GMP
Evaluation Log
Evaluation Log audit form. Long term action required,
will be discussed by management and
corrective actions / responsibilities and
time frames will be agreed and
documented.

PROCEDURE DESCRIPTION:

Note: Only 1 sample from each delivery is required to be sampled but all ingredients from each
delivery shall be recorded on the Raw Material Evaluation Log

1. As each shipment of raw materials is received:

The QA Technician shall take one 100 g sample (approx) from each lot or 50 bags of 1
representative item in the shipment, (cut bags, take sample, re-seal bag) and:

 Place sample in a plastic sample bag,

 Evaluate raw material based on Pre-shipment sample, written specifications or previous
retention samples.

Note: in cases where sampling the raw material would compromise the integrity of the container (e.g. canned items), do not
sample.

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2. Once the raw material has been checked:

 Enter information in Raw Material Evaluation Log for each respective ingredient
 Create pallet tags and attach to pallets (product can NOT be transferred to storage area until it
has been tagged).
 If rejected, state reason on Raw Material Evaluation Log and follow QC Hold procedure
(SOP 04)
 Inform warehouse manager & purchasing personnel.

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