SOP on sampling procedure of packaging material

SOP on sampling procedure of packaging material

Objective:

  • To lay down the procedure for sampling of Packaging material.

Scope:

  • This SOP is applicable to sampling of packaging material at

 Responsibilities:

  • Chemist or above of Quality Control is responsible for sampling of Packaging Material.

Accountability:

  • Head – Quality Control

Procedure:Packaging material

  • Packaging material sampling shall be initiated after receiving the “GRN” from warehouse.
  • QC personnel shall enter the material details in Packaging material control register as    per Annexure No.A01 and allot A.R. No.
  • QC personnel shall generate labels of “SAMPLED” as per Annexure No. A08.
  •  QC personnel shall generate labels of “UNDER TEST” as per Annexure No. A09 The no. of “UNDER TEST” labels shall be ‘no. of container(s) + 1’.
  • QC personal shall go for sampling along with sampler’s report of packaging material as per Annexure No.A02 .
  • The separate sampler’s remark shall be used for each lot of batches.
  •  QC personnel shall check the materials as per GRN.
  • QC personnel shall have to ensure that “Quarantine” labels are affixed on each unit pack by warehouse department.
  • Fill the necessary details in sampler’s check list by taking the reference of goods receipt note (GRN).
  • Ensure that the surrounding area is clean, if not get it cleaned, prior to start of the sampling.
  •  Check the packing condition of the material.
  • Ensure that packs are cleaned externally and open the packages only after ensuring    the proper cleaning. Observe the material for any abnormalities and record it on the Sampler’s report of packaging material.
  •  In case of primary packaging materials like foil / PVC / vials & rubber plugs, sampling    person shall be wear the hand gloves & mouth mask to withdraw the sample for analysis and sampling shall be done under LAF.
  • In case of Pre sterilized flip off seal, sampling shall be done by Microbiologist under LAF of Aseptic area sampling booth.
  •  If no. of container / boxes are 5 or less than 5, then all container / boxes shall be sampled. If no of container /boxes are more than 5 then withdraw the samples randomly by opening different containers / boxes as per √n +1 rule, .where n is number of containers received in one lot.
  • 100 % sampling shall be carried out in case of Plain aluminum foils, Printed aluminum strip / blister foils, PVC, PVDC Films.
  • Sample quantity for analysis shall be taken as per Annexure No.03 . Put the sampled quantity in self-sealing polybag bearing the label of “SAMPLE FOR ANALYSIS” attached as per Annexure No. 04 .
  • After completion of sampling the material pack shall be resealed with BOPP tape or tied with the help of cable – tie and affix self-adhesive label of “SAMPLED” as per Annexure No. 08
  • Affix self-adhesive label of “UNDER TEST” on all container of that batch.
  • Carry out testing of the packaging material as per the laid down specification of respective material.
  • The sampling procedure described above will not be applicable for tertiary packaging material like shipper, pad, partition and corrugated trays. For these materials only one unit shall be collected, affix “SAMPLED” label and carry out the analysis as per laid down specification.

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List of Annexures / Formats

S.

No.

Format TitleAnnexure

Number

1Packaging Material Control RegisterA01
2Sampler’s Report of Packaging MaterialsA02
3Sample Quantity from Each Box/ RollA03

 References (if any).

Reason for Revision

For better cGMP & cGLP

Abbreviation: 

  •  cGMP             : Current Good Manufacturing Practice
  •  cGLP               : Current Good laboratory Practice
  • QC                  : Quality control
  •  SG                   : Sub General

Annexure 1

Packaging Material Control Register

Sr.

No.

   Date Name of  MaterialManufacturer

/ Supplier Name

GRN No.

/ Date

Quantity

Received

No. of

Containers

 

 A.R. No.

/ Date

Work-

sheet

No.

Sampled

Quantity

Sampled

by/ Date

Date of   analysisDate of completion

 

StatusAnalyzed by / DateRemarks
                

Annexure 2

SAMPLER’S REPORT OF PACKAGING MATERIALS

1.     Name of material :       
2.     Name of manufacturer / supplier:
3.     Item code: 4.GRN No.:
5.No. of packs / boxes received: 6.No. of packs / boxes sampled:
7.Quantity per box / pack: 8.Quantity sampled:
8.Total quantity received: 9.Date of sampling:
Physical condition of consignment
10.Nature of containersWooden/ polythene bag / gunny bag / paper bag / corrugated others…….………………
11.Physical condition of consignment Ok/ Not OK  (torn / seal open / damage)
12.Source of material Approved vendor / other
13.Analytical Report (COA) Received / Not received
14.Cleaning of surrounding area of consignment Ok/ Not OK
15.Proper consignment label affixed by party Yes / No
16.Proper Quarantine  label affixed by warehouseYes / No
17.Mixing of materialYes / No
18.After sampling resealing of boxes done Yes / No
 19.Remarks:
Sampled by:

(sign / date)   

 

Annexure 3

Sample Quantity from Each Box / Roll

Sr. No.Name of Material Sample Quantity
1Glass ampoules10 Nos.
2Glass bottles5 Nos.
3Cartons5 Nos.
4Catch box / catch cover for physician sample5 Nos.
5Plain aluminum foils1 meter from each roll
6Printed aluminum strip / blister foils1 meter from each roll
7PVC, PVC/ PVDC Films1 meter from each roll
8Pack inserts / literatures10 Nos.
9Labels10 Nos from each roll
10Plastic bottles/container5 Nos.
11Pilfer proof caps10 Nos.
12Rubber plugs10 Nos.
13Tear off / flip off seals10 Nos.
14Glass vials10 Nos.
15Corrugated shipper01 Nos.
16Hips tray05 Nos.
17Shrink / LDPE bag05 Nos.
18BOPP/CELLO tap01 Nos.
19Shrink /stretch film02 meter from sampled roll
20Shipper label10 Nos.
21HDPE drum01 Nos.
22Silica pouch20 Nos.
23Hologram label10 Nos.

 

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About Alice

Alice is the Author and founder of Drugsformulations, she is a pharmaceutical professional having more than 18 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, and Nectar life Science Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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