SOPs

SOP on testing and approval / rejection of packaging material

Testing and approval/rejection of packaging material

Objective:

To lay down a procedure for testing and approval/rejection of packaging materials.

Scope:                             

This sop is applicable for testing and approval/rejection packaging materials

Responsibility:

QC –Chemist or above shall be responsible for testing of packaging materials

QC-Executive / Nominee shall be responsible for reviewing of worksheet.

Accountability:

Head – QC shall be accountable for compliance of SOP.

Procedure:

Testing of packaging material:

The sampling of the packaging material shall be carried out by Quality Control chemist/officer

Perform the analysis of packaging material as per respective specification and general test procedure and record the raw data in respective worksheet.

If the tests result does not comply with specification, the same shall be informed to Head –QC for further action.

 Review of results and approval/rejection of Packaging Material:

Executive QC or nominee shall review the results against laid down specifications.

The head QC shall be responsible for final approval.

If the material is approved, generate “APPROVED” labels for each container and affix them on each box/bag over the “UNDER TEST” label in such a manner that the entire “UNDER TEST” label is completely covered by the “APPROVED” label.

If material is rejected, generate “REJECTED” labels and affix on each box/bag over the “UNDER TEST” label in such a manner that the entire “UNDER TEST” label is completely covered by the “REJECTED” label.

For Primary Packaging Material and Printed Sticker labels: Generate ‘2n+1’ labels of “APPROVED” or “REJECTED” for each A.R. No. Affix one label on the “Sampler’s Report of packing Material” for reference and remaining labels on the “UNDER TEST” label as well as in the core of each roll. Note: n is no. of rolls.

For secondary and tertiary Packaging Material: Generate ‘n+1’ labels of “APPROVED” or “REJECTED” for each A.R. No. Affix one label on the “Sampler’s Report of packing Material” as per Annexure No. A02 for reference and remaining labels on “UNDER TEST” label of each pack. Note: n is no. of packs.

Fill in the necessary details of quantity released / rejected and signature of Authorized Quality Control person in goods received note (GRN) . Retain QC copy (2nd copy of goods received note) and return rest of the copies duly signed, to warehouse.

Fill in the necessary details like status for approved / rejected, signature and date in PM Register.

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List of annexure / Formats:   

  S.No.Format Title
1Worksheet of shipper
2Worksheet of Foil
3Worksheet of carton
4Worksheet of sticker label
5Worksheet of Bopp Tape
6Worksheet of Aluminium Seal
7Worksheet of measuring cup
8Worksheet of  HDPE Bottle
9Worksheet of Catch Cover
10Worksheet of Leaflet
11Worksheet of Plain Alu – Alu Foil
12Worksheet of PVC Flim
13Worksheet of PVC Polybag
14Worksheet of PVDC Film
15Worksheet of Rubber Stopper
16Worksheet of Screw Cap
17Worksheet of Blister Foil
18Worksheet of Glass vial

Abbreviation:

QC: Quality Control

SOP: Standard Operating Procedure

A.R.No.: Analytical reference Number

GSM: Grammage

BOPP: Biaxialy oriented polypropylene

PVC: polyvinyl chloride

PVDC : polyvinylidene chloride

VMCH: Vinyl Methyl Cyclohexane

OPA: Oriented polyamide   

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ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 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. 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