The Sampling and Testing of Packing Materials should take account of at least the following: the quantity received, the quality required, the nature of the material (e.g. primary packaging materials and/or printed packaging materials), the production methods, and what is known of the Quality Assurance system of the Sampling and Testing of Packing Materials manufacturer based on audits. The number of samples taken should be determined statistically and specified in a sampling plan.
Sampling and Testing of Packing Materials is an important operation in which only a small fraction of a batch is taken. Valid conclusions on the whole cannot be based on tests which have been carried out on non representative samples. Correct sampling is thus an essential part of a system of Quality Assurance.
Purpose:-
It is established to provide the guidelines for the Sampling and Testing of Packing Materials so as to get the representative sample of the whole lot for analysis.
Scope of Sampling and Testing of Packing Materials:-
This procedure covers the Sampling and Testing of Packing Materials and this is applicable to Quality Control Department.
HSE Statement:-
Below mentioned PPE are required for the implementation of this SOP:-
- Safety Mask
- Safety Gloves
- Safety Goggles
Responsibilities:-
- Officer QC (Packing Material)
- Quality Control Manager
- Microbiologist
- Sr. Officer QC
Material:-
N.A
Definitions:-
Packing Material:
The wrapping material around a consumer item that serves to contain, identify, describe, protect, display, promote and otherwise make the product marketable and keep it clean.
Packaging is defined in the regulations as “all products made of any materials of any nature to be used for the containment, protection, handling, delivery and preservation of goods from the producer to the user or consumer.”
This applies where the product is one of the following:
- ‘Primary’ or ‘Sales’ packaging is packaging which forms a sales unit for the user or final consumer, for example, a vial containing powder
- ‘Secondary’ or ‘Grouped’ packaging is that which contains a number of sales units, for example, a cardboard outer containing a number of boxes of vial containing powder.
- ‘Tertiary’ or ‘Transport’ packaging is packaging that is used to group secondary packaging together to aid handling and transportation and prevent damage to the products, for example, the pallet and shrink wrap used to transport a number of cardboard outers containing boxes.
Sampling:
It is a part of a large bulk/product which represents the whole bulk/product and the characteristics possessed by this part are the same as that of the bulk/product.
- Packing material receiving & GRN preparation by material management
- Officer QC receives the GRN, enter the information in packing material receiving register and generate the QC number
- After necessary preparation officer QC go for sampling verifies the information on the container and conduct sampling as per plan
- Test the material against approved specifications and affix the label after MQC
After receiving the Packing Material, material management officer prepares Goods Receiving Note and send to Quality Control Department along with COA if any. Then he labels the containers / Poly bags in which samples to be taken as per sampling requirements. Then he labels the containers / Poly bags in which samples to be taken as per sampling requirements. After that he prepares the sampling labels to be pasted on the containers as per number of containers to be sampled. Physically damaged packs/ containers shall not be considered for sampling and the same shall be rejected. After collecting sample QC officer affixes the “Sampled” label on container(s) which are sampled.
Description:-
A- Sampling:
- After receiving the Packing Material, material management officer prepares Goods Receiving Note and send to Quality Control Department along with COA if any.
- QC officer receives the GRN, enters its information in the Packing Material Log Book and assigns it a QC number.
- Then he labels the containers / Poly bags in which samples to be taken as per sampling requirements.
- After that he prepares the sampling labels to be pasted on the containers as per number of containers to be sampled.
- QC Officer checks the number of packages received against GRN.
- Physically damaged packs/ containers shall not be considered for sampling and the same shall be rejected.
- QC Officer withdraws the samples for testing as per sampling plan by considering the normal inspection level.
- After collecting sample QC officer affixes the “Sampled” label on container(s) which are sampled.
Testing of Packing Materials
- After sampling QC officer will conduct the testing of packing materials against the approved specifications.
- After analysis Quality Control Officer will prepare the analytical report and forward it to Quality Control Manager for approval.
- On behalf of the analytical results, Quality Control Manager takes decision against that particular material/GRN either to be released or rejected.
- If material complies 99% of the total consignment it will be released for use. Defects up to 1% are not charged to the supplier.
- If material complies 97% of the total consignment it will also be considered as released and the corresponding percentage of rejection on the basis of sampling will be charged to supplier.
- Defects in the lot if more than 1% will be charged to the supplier.
- More than 3% defects in the lot are not acceptable, whole lot should be considered as rejected, however if we left with no option to use the GRN due to any reason, then the corresponding percentage of defects based on the sampled quantity will be charged to the supplier.
- After the decision of the QC Manager, Quality Control Officer affixes the label on the respective GRN/Lot to declare its status.
- All excess packaging materials after completion of testing and reporting shall be destroyed as per laid down procedure.
- If retest date is provided by the supplier then Officer QC put this retest date on the column available in the release label, if supplier mention only the expiry date then Officer QC will put 1 month prior retest date to the expiry date in the column on the label.
Record:-
- Packing Material Receiving Record
- Certificate of Analysis Packing Material
References:-
- In-house/International Guidelines
Distribution:-
- This SOP has to be distributed in below mentioned Departments:-