STANDARD OPERATING PROCEDURE Title: Packing Material Analysis

1. Purpose

a) It is established to provide a standard procedure for “PM Analysis”.

2. Scope

a) It is applicable for PM analysis.

3. Responsibilities

a) QC Manager

b) PM Analyst

4. Procedure

a) PM sample is handed over by QA officer to PM Analyst, along with PM Analysis request.

b) Following parameters are needed to be checked.

1) Text

2) Card color

3) Printing color

4) Grammage

5) Thickness

6) Dimension

Text, card color and printing color are compared with reference standard checked and signed by QC Manager.

To check card grammage, cut a square piece (e.g. 4x4 cm or 5x5 cm) and find out its weight.

Weight of card or paper is divided by area (e.g. 16 or 25 respectively) and multiplies it with 10,000 to convert cm² into m². The unit for grammage is gm/m².

In case of labels, vials, ampoules, seals, rubber stoppers, average weight is required.

Micrometer (Screw gauge) is used to measure the thickness of card. Note the reading on circular scale and multiply it with least count 0.01. It shows the thickness in mm; convert it to μm by multiplying it with 1000.

Dimensions are measured either by scale or vernier caliper.

Grammage, thickness and dimensions are compared with packing material specifications.

In case of Al. tubes, glass containers, and rubber stoppers testing, follow the procedure specified in relevant SOPs.

PM sample is physically checked for any color variation, pasting problem, misprinting or any sign of damage.

After complete analysis, QC # is allotted to the specified lot, in Daily Entry Log book for Packing Material. PM report is prepared accordingly, and “PM Approval” slips in case of approved material and “Not Approved” slip in case of rejected material, is issued.

5-10 samples of packing material are kept as “Retained Sample”, labeled with QC # and analysis date, whether it is approved or rejected.

5. References:

Chemical test for glass containers GL/SOP/QC/033

Chemical test for Al.Tubes GL/SOP/QC/032

Chemical test for Rubber Stoppers GL/SOP/QC/035

6. Quality Records:

Required Record	Form Reference No.
Daily Entry Log book for Packing Material	QF/040/01
Packing material analytical report	QF/066/01
Packing material approval slip	QF/060/01
Not approved slip	QF/019/01