Testing of Primary Packaging Materials

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2781

1.0 Objective

To lay down a procedure for Testing of Primary Packaging Materials.

2.0 Scope

This Standard Operating Procedure is applicable pharmaceutical formulation plant.

3.0 Responsibility

QC- officer / Executive          : Shall be responsible for carrying out sampling and testing of Packaging Material.

Head QC                                : Shall be responsible for compilation, review of results and Release of Products.

Head QA                               : Shall be responsible for compliance of this SOP

4.0 Abbreviations and Definitions

Primary Packaging Material    : Packaging Material which is directly in contact with product  e.g. laminate peel able Blister lidding, cold form Laminate, HDPE Bottle, cotton plugs, etc.

SOP                                         : Standard Operating Procedure Quality Control

QC                                          : Quality Control

QA                                          : Quality Assurance

HDPE                                     : High Density Polyethylene

GTP                                         : General Testing Procedure

COP                                        : Certificate of Analysis

5.0 Procedure

5.1 All Primary Packaging material shall be tested as per approved specification and test methods.

5.2 The primary packaging materials shall be tested for microbiological limit testing as per GTP No. P-080-T, in case of only first three consecutive consignments from the Vendor.

5.3 After every one year, the approved primary packaging material shall be retested against test parameters mentioned on the respective specification, along with microbiological testing.

5.4 Sampling of the material to be retested shall be done as per the respective SOP titled “Sampling Procedure for Packaging Materials”.

5.5 Stores shall be responsible to intimate QC about retesting date.

5.6 Once the Material has been identified to be retested, material shall be shifted from approved Quarantine area to under test area and “UNDER TEST” label shall be affixed.

5.7 After sampling of the material, “SAMPLED” label shall be affixed below the “UNDER TEST” label.

5.8 QC shall perform the analysis and as per results of analysis, QC officer shall affix “APPROVE LABEL” or “REJECTED LABEL” over the “UNDER TEST” label of each unit pack of primary packaging material container as per relevant SOP.

6.0 Forms and Records

Nil.

7.0 Distributions

7.1 Master Copy Documentation Cell (Quality Assurance)

7.2 Controlled Copies Quality Assurance, Quality Control, Production and Stores

8.0 History

     Date    Revision Number                       Reason for Revision
                       New SOP

1 COMMENT

  1. Thanks for these valuable information, but I have a question about the microbial limit specifications (that means how many colony forming units for TAMC and TYMC which are accepted) for primary packaging material used for pharmaceutical products.

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