Drugsformulations
Inspection, Sampling and Storage of Packing material
Objective
- To lay down a procedure for Inspection, Sampling and Storage of Packing Material.
Scope
- This Standard Operating Procedure is applicable in Packing Material Store for Inspection, Sampling and Storage of Packing materials
Responsibility
- The personnel of Packing Material Store & QC shall be responsible to follow the procedure mentioned in this SOP.
- Concerned Department Head/Incharge shall be responsible for implementation of the procedure mentioned in this SOP.
Accountability
- Concerned Department Head/Incharge & QA Head shall be accountable for the implementation of this
Abbreviations and Definitions
- SOP : Standard Operating Procedure; a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
- QA : Quality Assurance
- QC : Quality Control
Procedure
Receipt and Inspection of Containers
- Upon receipt of packing material, the same shall be placed in the quarantine store attached with the Packing Material Store.
- In-charge of Packing Material Store shall inform the QC Department for inspection of containers and taking of samples for test and scrutiny on the format, “Packing Material Receipt Intimation”, given as per Annexure-I
- The QC Personnel, on the receipt of intimation as per Annexure-I, shall visit the Packing Material Quarantine Store.
- The QC Personnel, along with the In-charge of Packing Material Store, shall visually
- Inspect all the containers of the packing material as per check list given in Annexure-II titled “Check List for Incoming Packing Materials”.
- First of all the QC Personnel shall note the number of containers of a material. He shall serialize all the containers as X of Y e.g. if there are 5 containers of the same lot then each container shall be denoted By its individual serial number such as 1/5, 2/5, 3/5, 4/5 and 5/5.
Sampling for Test and Scrutiny
- After visually inspecting all the containers, the QC Personnel shall decide the number of samples to be taken depending upon the number of containers of each lot of the Packing Material.
- Each lot of Packing Material shall be sampled.
- In case of damage of consignment, ascertain the extent of damage and the extent to which the consignment can be used. Enter the above details in the check list format Annexure-II.
- The QC Personnel shall assign a QC reference number to the material sampled.
- Different lots of the different materials shall have different QC reference numbers.
- The containers shall be opened, sampled and closed in such a manner as to prevent Mix-up of Their contents with other packing materials.
- Containers in which samples are taken shall be labeled properly with required particulars such as:-
- Name of the product for which the Packing Material is to be used.
- Batch Number of the product, if applicable.
- Container No.
- Total No. of containers
- QA Reference Number
- Date of Sampling
- Sampled by
- The containers from which the samples are drawn shall be identified by affixing labels bearing the below noted particulars:-
- “Quarantined- Sampled” label of yellow colour.
- Name of the product for which the Packing Material is to be used.
- Batch Number, if applicable
- Container No.
- Total No. of Containers
- QC Reference Number
- Date of Sampling
- Sampled by
- The number of “Quarantined-Sampled” labels affixed shall be at least equal to the number of containers Opened. The labels shall be affixed to the front side of the containers so that they are easily visible.
- Samples of packing materials shall be taken in polythene bags.
- Quantity of sample drawn must be sufficient for control test purpose and also for reference purpose. In general quantity of each sample should be twice the quantity required for all tests to be carried out.
- Samples which are drawn for test and scrutiny purpose must not be returned to the containers from which those were taken.
- Containers from which samples are to be drawn should be chosen at random. In addition the containers which show damage or any other sign different from original, should be chosen for sampling.
- For sampling, only one container shall be taken at one time for drawing sample.
- The consignment shall remain in quarantine store till the testing is completed and the sample is approved or Rejected by the QC Department.
- The sample drawn by the QC shall be taken to the QC Department for test and scrutiny and he shall test / scrutinize the PM Store as per the specifications given in STP regarding Testing of that Packing Material.
- QC Personnel shall prepare his test report on format given in Annexure- III which shall be retained by him as a record.
- Each consignment meeting the appropriate specifications and any related tests, shall be approved and released for use.
Labelling of Approved / Rejected Packing Materials
- Approved materials shall be identified by affixing “Approved” or “Released” labels of green colour on each containers at easily visible position. Simultaneously the ‘Quarantined-Sampled” labels shall be removed and accounted. The label shall bear the following particulars :
QC Release Slip For Packing Material
Name of the product for which the Packing Material is to be used, its Batch no., and
Code No.
QC Reference No. and Date
Lot Qty.
Accepted Qty.____________ Rejected Qty._____________
Name and Sign of the chemist.
- Affix adequate number of “Approved” labels on the containers at different levels.
- If the consignment is rejected, affix “Rejected” label of red colour on each container. The label shall bear the following particulars :
- QA Rejection Slip For Packing Material
- Name of the product for which the Raw Material is to be used, its Batch No. and Code
- QA Reference No. and Date
- Lot Qty.
- Accepted Qty.____________ Rejected Qty.____________
- Name and Sign of chemist.
- Any label affixed to the original container of the material shall not cover the important particulars given on the label of the manufacturer / Supplier.
Storage of Approved Packing Materials
- Move the “Approved” material from the quarantine area to the “Approved Packing Material Store”, separately provided for Labels and other packing materials.
- The approved Packing Materials shall be stored at the temperature as per storage conditions applicable to the material.
- All the containers of the approved Packing Materials shall be properly stored on racks or pallets and spaced so as to allow proper cleaning and inspection. No material shall be stored directly on the floor.
- The containers from which the sample has been taken shall be properly closed after sampling to avoid mix –up and exposure to dust.
- All the approved Packing Materials shall be re-examined (re-tested) after the period of one year and the material shall be re-labelled accordingly.
- The printed labels shall be stored separately in pigeon holes or drawers, product wise in a separate room having double lock and Key, the one key of which shall be with the store Incharge and the other with QA Department.
Storage of Rejected Packing Materials
- Move the rejected Packing material to the “Rejected Material Area” with the approval of Quality Assurance Department.
- Necessary steps shall be taken by the In-charge of Packing Material Store for the return of Rejected Packing Material to the supplier, for destruction as per SOP titled “Destruction of Materials and Documents,” as the case may be, with the approval of QA.
Forms and Records (Annexures)
- Intimation Regarding Receipt of Goods : Annexure-I
- Check List for Testing the Received Goods (RM/PM) : Annexure-II
- Certificate of Analysis (Packing Material) : Annexure-III
Distribution
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance, Production, Quality Control, Stores, Engineering, & Human Resource Development
History
Annexure-I
Intimation Regarding Receipt of Goods
| Intimation for Inspection and Sampling of Received Material (R.M /P.M) Intimation Date: From : R.M Store/P.M Store To : Q.A/Q.C. Department Sir, You are requested to depute a person of your department for inspection and sampling of the Following material to verify its quality Item Name Batch No. Generic Name Batch Quantity Invoice Challan No. & Dt No. of Containers GRN No. & Date Total Qty Recd. Manufacturer Mfg. Date Supplier Exp. Date Store Incharge :____________ Date :____________ Intimation Received By :_____________ Material Sampled by:____________ Date :_____________ Date :____________ |
Annexure-II
Check List for Testing the Received Goods (RM/PM)
Qty. in Invoice : Storage, if any : Qty. in each container : Qty. Received :
I/C PM Store____________ QA Officer ___________ Date ____________ Date ___________ |
Annexure-III
Certificate of Analysis (Packing Material)
| T.R. No. | T.R. Date | |||||||||||||||||||||
| Item Name | Sample Qty. | |||||||||||||||||||||
| Generic Name | Sampled On | |||||||||||||||||||||
| Batch No. | Date of Test | |||||||||||||||||||||
| Invoice /Challan No: Date : | Date of Release | |||||||||||||||||||||
| G.R.N No. | Total Qty. Received | |||||||||||||||||||||
| Manufacturer : | Accepted Qty. | |||||||||||||||||||||
| Supplier : | Rejected Qty | |||||||||||||||||||||
| Specification No. | ||||||||||||||||||||||
| ||||||||||||||||||||||
