SOP FOR RECEIPT, TESTING AND RELEASE OF

RAW MATERIAL

1.0 OBJECTIVE

1.1 The quality of a pharmaceutical formulation is very largely

governed by the quality of the raw materials that goes in to it.

Testing of raw materials, therefore, is of the almost importance.

2.0 SCOPE

2.1 This Procedures is applicable for receipt, testing and

release of raw material in quality control Laboratory at Park

Pharmaceuticals.

3.0 RESPONSIBILITY

3.1 Q.C Department.

4.0 ACCOUNTABILITY

4.1 Quality Control Manager.

5.0 PROCEDURE
 5.1 The testing any raw material is -

5.1.1 To confirm that the material is what it is claimed to be

5.1.2 That is has the characteristics that will produce the desire

quality in the dosage form produced from it and to provide

assurance that the keeping quality of the final product will not be

affected by defects in the raw material. This document deals with

the handling of raw materials form the time of receipt in the

factory up to the time they are used up in manufacturing.

5.2 RECEIPT OF RAW MATERIALS

5.2.1 The receipt of each delivery of each raw material to be

recorded.

5.2.2 Each delivery of raw material to be examined visually on

receipt, for proper labelling as to the contents of containers:

container damage and contamination. Damaged materials

should be segregated from other materials and dealt with a

suitable manner (e.g. returned to the supplier or

destroyed).

5.2.3 Each delivery of raw material to be given a control reference

number which can be related to the material throughout

number enables one to get full details of the delivery.

5.2.4 The reference number to be permitted verification of :

5.2.4.1 Name of material

5.2.4.2 Quantity of material received and number of

containers

5.2.4.3 Date of receipt

5.2.4.4 Name and address of the supplier / manufacturer

5.2.4.5 The supplier reference number /batch number of the

manufacturer

5.2.4.6 Result of tests carried out.

5.2.4.7 Release of material (approval or rejection of

consignment /batch.)

5.2.4.8 Different batches within one-month delivery to be

regarded as separate batches for testing and

release purpose.

5.2.5 The different number must be appeared on the container

label before the material is released for processing.

5.2.6 Every delivery of material to be held in quarantine until

released for use on the authority of the Quality Assurance

Manager.
5.2.7 Quarantine may be effected either by physical segregation

or by means of documentation such as a label or tag attached

to the containers showing quarantined statue (e.g. UNDER

TESTING or QUARANTINED labels). Such labels or tags are not

readily be detached, defaced and to be preferable be of a

nature of form which prevents confusion with any similar labels

previously applied by the supplier of the raw material.

5.2.8 Status labels to be applied to raw material containers

only persons authorised by the Quality Assurance

Manager. As the status of the material charges (i.e. when

the material is approved or rejected) the status labels to

be changed accordingly.

5.2.9 To the extent possible, status labels to be adjacent to

the original labels on the containers.

5.3 TESTING OF MATERIALS

5.3.1 No batch or lot of consignment of raw material must

pass to the production area. Until representative samples

have been taken, until all appropriate tests have been

completed and the results indicate the specifications have

been met until Quality Assurance has authorized the use of

the material.
5.3.1.1 Adequately detailed written methods of sampling and

analysis of all raw materials must be drawn up. These

methods must be authorised by the Quality Assurance

manager.

5.3.1.2 The established procedures for sampling and testing of

raw materials to be reviewed regularly and the suspended

versions to be replaced. A complete written collection of the

current versions to be maintained all the time.

5.3.1.3 Sampling of raw materials for analysis to be carried out

in a accordance with an authorized procedure.

5.3.1.4 Sample of all raw materials to be tested for compliance

with the specifications laid down for them. As the possibility of

incorrect labelling of containers of raw materials cannot be

ruled out, it would be advisable to do an identification test on

the contents of each and every container in a consignment.

5.3.1.5 With large deliveries in many containers this may

present practical and economic problems. In such cases

adequate quality control checks to be done at the time of

manufacture, which will reveal the use of wrong material.

5.3.1.6 Tests other than identification may be done on

individual samples or a pooled sample, depending on the

the considerations such as the nature of each material, the

factory’s experience with the material and its supplier and the

use to which the material and its supplier and the use to

which the material is put production etc.

5.3.1.7 Each lot of material that is liable to

 Contamination with dirt

 Microbiological contamination

 Inspect infection or to any other contamination

that is objectionable in view of its intended use to be

examined against specifications for each contamination.

5.3.1.8 Where there are statutory methods of testing of materials

(e.g. pharmacopoeia) alternative test methods may be used,

provided there is written is evidence to show that such

methods are at least as precise and specific as the official

ones.

5.3.1.9 After testing is over, a sample of each raw material, sufficient

in size to permit analytical re-examination to be retained.

5.4 RELEASE OF MATERIAL

specifications may be approved and release for use.

5.4.2 Release of materials is subject to ensuring by the Quality

Assurance Manager that the storage conditions in the

warehouse are satisfactory and that the material, which has

been released will not deteriorate during storage.

5.4.3 Containers of material, which have been tested and

released by Quality Assurance, must have on them authorized

PASSED labels securely attached. If a QUARANTINED or

UNDER TEST status label has been used it must be replaced

by to cancelled and covered with the PASSED label.

5.4.4 PASSED labels have the following details on them.

5.4.4.1 Name of material

5.4.4.2 Code Number

5.4.4.3 Reference number or laboratory reference

number

5.4.4.4 Date of Issue /Approval

5.4.4.5 Re-test date

5.4.4.6 PASSED or APPROVED in bold capital

5.4.5 An appropriate period of time up to which any material may

be expected to Comply with its specifications under the

and there must be a system by which material have not been

released for manufacturing are re-tested before they are

released again for use in production.

5.4.6 Having on the PASSED labels, wordings such as “RE-

TESTED ON” can ensure testing. With the appropriate date

inserted.

5.4.7 Materials to be re-tested on or before re-tested dates and if

they are satisfactory, new PASSED labels to be affixed and, if

necessary and justified, new re-tested date to be assigned.

5.4.8 As a rule, no material has a retest date of more than 12

months.

5.4.9 Any lot of raw materials that does not meet the appropriate

written specifications to be rejected and carry authorised

REJECTED labels, where a ‘QUARANTINED ‘ or UNDER TEST

status label has been used it must be replaced by of cancelled

and covered with the ‘REJECTED ‘ label. The materials then

be segregated from other materials in the warehouse.

5.4.10 Status identification labels have a distinctive colour scheme

for easy identification e.g. PASSED in green, REJECTED in red,

UNDERTEST in yellow etc.