Objective:To lay down a procedure for issuance of packaging materials and transfer of issued materials from warehouse to production area.
- Scope:This procedure is applicable for issuance of packaging materials and transfer of issued materials from warehouse to production area of the formulation plant at (Pharmaceutical Company Name).
- Packing material Store personnel shall be responsible to follow the procedure mentioned in this SOP.
- Packing material Store in-charge shall be responsible for implementation of the procedure mentioned in this SOP.
- Accountability:Concerned Department Head and QA Head shall be accountable for implementation of this SOP.
- Abbreviations and Definitions
PM – Packaging Material.
A.R. No. – Analytical Report Number.
ROPP – Roll on Pilfer Proof.
BOPP – Bi-axially Poly Propylene.
QA – Quality Assurance
SOP – Standard Operating Procedure
- Production Officer or above shall submit the Packaging Order (s) for any particular batch or batches of a product duly filled and signed to officer or above, warehouse for issuance of approved packaging materials.
- After receipt of Packaging Order(s) of a batch or batches of the same product, the officer or above, warehouse shall make entries in ‘Packaging Material Stock Register’ according to First In/First Out basis.
- Packaging Materials for over printing shall usually be issued first as per Packaging Order and the corresponding entries of the stock register are made in Packaging Order and same shall be duly signed by officer or above warehouse. After issuing, production personnel will receive the required packaging materials.
- Packaging materials not to be over printed shall be issued to Production and the corresponding entries of the stock register are made in Packaging Order. Packaging Order shall be duly signed by officer or above, warehouse. After issuing production personnel will receive the required packaging materials.
- Warehouse personnel shall affix the ‘Packaging Material Dispensing Tag’ as per Annexure-I duly filled and signed on the issued lots of packaging materials of a batch instead of all individual containers.
- During the issuance operation warehouse and production officer or above shall check each material for its.
- Physical status of shipper / container / packing from which packaging material is to be issued.
- Name of the material
- R. No.
- Specifications (Item Code)
- Product Name
- Batch No.
- Quantity/Gross Wt. /Tare Wt. /Net Wt.
- Labels & cartons are received in standard packing and are verified at the time of receipt and the same are issued in numbers by counting. If there is less quantity to be issued than the standard pack the same is issued by counting in numbers.
- Packaging inserts, ROPP caps and all other materials to be issued in large quantities where counting is difficult are to be weighed on a balance and subsequently issued. Officer or above Packaging Material warehouse shall find out the average weight of unit material by finding the average weight of 10 or 100 units. Calculate the required weight to be issued by multiplying the average weight of unit material and quantity in numbers.
- Precaution shall be taken that only one item shall be issued at a time.
- After completion of weighing of material its respective ‘Packaging Material Dispensing Tag’ shall be attached as per Annexure – I with each lot of container(s) containing the issued packaging materials. It shall be counter checked by the Production officer or above and duly signed in ‘received by column’.
- All issued packaging materials of a batch or batches of the same product shall be transferred in shippers / containers to the respective Production section and shall be kept on clean pallets in a secured place.
- Aluminium foil, PVC rolls are to be issued in excess weight wherever issuing exact weight as given in Packaging order is not practical.
- The weight issued in excess of the packaging order shall subsequently be returned by the material returned note after packaging operations are over.
- If consumption of foil or PVC is more than that allowed in packaging order the authorization for the excess amount used shall be obtained on the same day or next working day.
- BOPP tapes are issued in numbers and wherever remainder of a roll remains the same may be returned.
- Forms and Records
- Packaging Material Dispensing Tag – Annexure I
- Master copy – Quality Assurance
- Controlled copies – Warehouse, Quality Assurance, Production
|Date||Revision Number||Reason for Revision|
Annexure – I
|Company Logo||PACKAGING MATERIAL DISPENSING TAG|
| LOT NO.:_________________
A.R. NO. ___________________
PRODUCT:_________________________ Batch No. ___________________
QUANTITY____________________ NET WT.:_______________
Container NO.: _____________ GROSS WT.:____________
ISSUED BY:___________________ RECEIVED BY:__________
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Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit 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. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube