Standard Operating Procedure for Analysis and Release of Packaging Materials
Standard Operating Procedure for Analysis and Release of Packaging Materials
1. Purpose:
To lay down a procedure for Analysis and Release of Packaging Materials.
2. Scope:
The scope of this is applicable document is to provide the procedure for Analysis and Release of Packaging Materials in quality control laboratory at [company name].
3. Responsibility:
QC Analyst: Analysis of packaging materials
QC Supervisor: Allocation of packaging material sample, submit samples to analyst for analysis
QA Reviewer: Review the data.
QC Head: Approval of raw materials, and ensure the compliance of this SOP.
4. Definitions:
Not Applicable
5. Procedure:
• All incoming packing material must be examined in accordance with the applicable standard.
• Any Under test or Approved label or Certificate of analysis that has to be reproduced must be done through a re-print request with proper reason. The Quality Assurance department must approve it.
• The QC Analyst will conduct the analysis and enter the data into the LIMS. After completing the analysis, the QC analyst must print the Approved/Rejected label from the LIMS.
• When packaging materials, such as labels, foils, or films, are supplied in roll form, physical tests such as breadth and grammage must be done as follows:
| Pack received | Width and grammage |
| Up to 3 | All Rolls |
| 4 to 8 | 3 Rolls |
| More than 8 | 5 Rolls |
• All samples received must undergo a description test.
• Identification test shall be performed on any one of the samples.
• For materials other than those received in roll form, dimension, grammage, and weight tests must be performed on 5 samples or as specified by the corresponding method of analysis.
• The Packaging Material supervisor shall assign the samples for analysis to the QC analyst in LIMS to carry out Packaging Material analysis. Following allocation, any leftover samples must be stored in the Sample Storage Cabinet.
• The QC analyst will check the sample allocation in the LIMS.
• Once the sample is received, the QC analyst must execute the analysis in accordance with the specifications and method of analysis.
• After completing the analysis and putting the results into the LIMS, the reviewer must evaluate the test data in the LIMS as well as in the corresponding instruments, as well as conduct an audit trail review.
• Following the end of the review activity, Head QC will approve or reject the packaging material.
•Certificate of Analysis (CoA) shall have following details such as, Material Name, Material Code, Inspection Lot No., Specification Id., Specification Rev. No., Quantity Received, A.R. No., Manufacturer. Batch No., Received Date, Manufactured By, Date of Release, Retest Date, and results as per the tests specified in the specification.
• QC analyst shall print the Approved or Rejected label from LIMS as per number of containers. For Materials comes in Bulk, labelling can be rationalized based on risk scenarios.
• Approved label shall contain the information such as Material Name, Material Code, A.R. No., Manufacturer, Mfr. Batch No., Mfg. Date, Exp. Date, Quantity, Retest Due On, Sign, Date and number of packs.
• Rejected label shall contain the information such as Material Name, Material Code, A.R. No., Manufacturer, Mfr. Batch No., Mfg. Date, Exp. Date, Quantity, Reason for rejection, Sign, Date and number of packs.
• In case of the material received in the role form such as Aluminum Foils, Blister Films, and Roll Labels, affix Approved or Rejected label at inner side of core.
• If packaging material is rejected due to a quality concern, a Rejection Report must be filled. The rejection shall be verified by QA. Once the material is rejected, inform to warehouse head to locate the material in rejected area.
• After completion of analysis and review activity, QC supervisor shall discard the remaining samples as per respective SOP applicable for destruction of samples.
• Sample preparation for Autoclave and TOC test:
• Microbiologists will prepare the samples.
• Purified water or Millipore water should be used for sample preparation. Make sure the beaker you’re using to catch the water is clean and dry.
• For sample processing, use freshly obtained filtered water.
• The sampling bottle must be entirely filled up to the neck and allowed to overflow to evacuate the air.
• Aluminum foil rinsed with pure water must be used for bottle wrapping.
• The autoclave sample must be checked for leakage and aluminium foil unwrapping.
• Following autoclaving, the produced sample must be evaluated for TOC and other specified tests.
• Handling and using of printed packaging material Shade Cards and Standard Specimens:
• Shade card and standard specimen sample shall be designed and approved by Artwork department.
• Validity period defined as 2 years for shade card and standard specimens from date of preparations or in case of artwork is revised. Validity shall be mentioned on the shade card.
• Two copies of approved shade cards and standard specimens shall be in QA department from artwork department. One copy shall be maintained by QA Department and another will be maintained by QC Department
• On receipt of shade card and standard specimen sample shall be verified by QA department before it shall be used by QC for analysis. Inward and outward of artwork shall be maintained by QA department.
• One copy of shade card and standard specimen sample shall be distributed to QC department and the record for the same shall be maintained in respective format for recording.
• For printed packaging material, test for color and printing of the text matters shall be performed as per approved shade card and standard specimens which are within its validity period.
• In case of change in artwork, change in packing material, expiry of validity period, discontinuation of packing material or any other reason, shade cards and standard specimen shall be obsolete by QA department. The obsolete copy shall be maintained by QA for future reference.
• QA shall destroy retrieved QC copy of shade cards and standard specimen samples by shredding as per respective SOP for destruction.
• For standard shade cards and standard specimen sample near to its validity period shall be identified and intimated to artwork department to receive new shade cards and standard specimen.
• New shade cards and standard specimen samples shall be made available by the artwork department before delivery of new consignment.
• Procedure for Analysis of Cotton fiber/ Puritan Grade Cotton Pharmaceutical Coil:
• Width of cotton fiber (Maximum Wide) shall be measured under microscope.
• Take a few pieces a cotton fiber sample and prepared a specimen slide for adequate visibility and covered the same with a coverslip.
• Select and use the objective magnification 10X and refer reticule least count (microns) as per following table.
| Objective Magnification Reticule | Least Count (microns) |
| 5X | 20 |
| 10X | 10 |
| 40X | 2.5 |
• Put the specimen slide under microscope and adjust microscope for adequate view of sample showing clear view of fiber having at least single cell and maximum wide in width.
• Measure width of cotton fiber in reticule scale inserted in the eyepiece by adjusting the specimen slide in such a way that maximum width of cotton fiber covered by reticule scale under microscope and records the observed value.
• Length of cotton fiber (longest fiber) shall be measured separately with calibrated scale and record the observed value.
6. Frequency:
On receipt of new material or during retest
7. Formats:
7.1 Specimen for Approved Label
Material Name
Material Code
A.R. No.,
Manufacturer
Mfr. Batch No.
Mfg. Date
Exp. Date
Quantity
Retest Due On
Sign, Date
Number of packs
7.2 Specimen for Rejected Label.
Material Name
Material Code
A.R. No.
Manufacturer
Mfr. Batch No.
Mfg. Date
Exp. Date
Quantity
Reason for rejection
Sign
Date
Number of packs
7.2 Handling of Shade Cards and Standard Specimen Sample.
Sr.No.
Date of Receipt
Material Code
Material Name
Manufacturer Name
No. of Copies Received By QA (Sign/Date)
Valid Upto
QC copy distributed by (QA) (Sign/Date)
QC copy Received by (Sign/Date)
After validity Completion QC copy
Returned/ Retrieved by (QC) (Sign/Date)
After validity Completion Obsolete By (QA copy) (Date/Sign)
To refer more similar procedures of quality control laboratory, click here.
To refer more SOP of Pharmaceutical Industry, click here
WHO guidelines for sampling of pharmaceutical products and related materials
