Finished Product Handling, Purpose:
Finished Product Handling, The of these guidelines is to assist in ensuring the quality and identity of pharmaceutical products during all aspects of the distribution process such as storage, distribution, transportation, packaging, labeling, documentation and record-keeping practices.
Finished Product Handling, Scope:
This procedure is applicable for all finished products received and stored after receiving from Packaging department by Central Warehouse and different depots of XX Pharmaceuticals Ltd.
Definitions / Abbreviation:
[][]QA – Quality Assurance
[][]DIC – Depot In Charge
[][]ERP – Enterprise Resource Planning
[][]CWH – Central Ware House
[][]FIFO – First In First Out
[][]XX – Current version no. of the SOP
Responsibilities:
[][]The roles and responsibility is as follows:
Head of Distribution
[][]Head of Distribution shall responsible for overall the distribution activities.
Depot In Charge (DIC), Central Warehouse & Different Depots
[][]To verify, receive, storage and distribution the finished goods ensuring all the quality.
Head of Sales
[][]To monitor the distribution procedure as per market requirement.
Head of Marketing
[][]Prepare the market requirement for distribution and follow-up of overall activities.
General Manager, Plant
[][]Follow-up of overall activities.
Executive, Vat
[][]Follow the distribution activities as per Government legislation
Executive, QA
[][]Responsible for effective implementation and monitoring of procedure.
[][]Annual depot audit to verify the effectiveness of this procedure.
Manager, HR & Admin
[][]Shall responsible for monitor the effective distribution procedure
Manager, Quality Assurance
[][]To approve of all the distribution activities.
Procedure :
Precautions:
[][]The entire finished product should be handle carefully during distribution, storage, ensuring the quality and identity of the product.
[][]The entire finished product should be stored in product wise respective area maintaining product’s storage condition.
[][]During distribution FIFO should be controlled to avoid mix-up & errors.
Storage :
[][]Finished product will be received by central warehouse personnel from packaging department after getting the finished product release note from QA.
[][]Released finished product will be stored in the central warehouse at the product wise respective area as per storage condition.
[][]Warehouse personnel will monitor and record the temperature in “temperature monitoring record sheet ( Annexure – I)” for twice in a day.
[][]Storage areas should be designed or adapted to ensure appropriate and good storage conditions.
[][]In particular, they should be clean and dry and maintained within acceptable temperature limits. Products should be stored in the pallet which is suitably spaced to permit cleaning and inspection.
[][]Physical or other equivalent segregation should be provided for the storage of released, rejected, expired, recalled or returned products and suspected counterfeits.
[][]Broken or damaged items should be withdrawn from usable stock and stored separately up to final disposition.
[][]Storage areas should be provided with adequate lighting to enable all operations to be carried out accurately and safely.
[][]Periodic stock reconciliation should be performed by comparing the actual and recorded stocks. Stock discrepancies should be investigated by a multidisciplinary committee headed by HR & Admin.
Distribution
[][]All parties involved in the distribution of pharmaceutical products have a responsibility to ensure that the quality of pharmaceutical products and the integrity of the distribution chain are maintained throughout the distribution process from the site of the manufacturer to the entity responsible for dispensing or providing the product to the target consumer as per Government legislation.
[][]Head of Distribution send the depot wise market allocation to central ware house as per marketing/sales requirement.
[][]Central warehouse personal will prepare the released finished product as per market allocation for different depots along with necessary tertiary packaging.
[][]In-charge, CWH will prepare invoice/challan copy as well as ERP entry as per different depot requirement approved by head of Plant or his designee.
Executive, Vat will prepare the vat challan according to depot allocation ( through Musak-11) as per Government rule.
[][]After performing all the related activities, finished products will be transferred to different depot by company own transport or transport agent along with vat challan and invoice copy.
[][]DIC or designee will receive and check the finished pack according to invoice and to be stored following the procedure described on previous steps.
Market Dispatch :
[][]DIC will allocate the finished product as per market requirement for sale. The dispatch and transportation of products should be undertaken only after the receipt of a valid delivery order, which should be documented
[][]Dispatch record will be prepared by DIC and should include at least the following information:
[][]Date of dispatch;
=>Complete business name and address (no acronyms), type of entity responsible for the transportation, telephone number and names of contact persons;
=>Complete business name, address ( no acronyms), and status of the addressee (e.g. retail pharmacy, hospital or clinic);
=>A description of the products including, e.g. name, dosage form and strength ( if applicable);
=>Quantity of the products, e.g. number of containers and quantity per container ( if applicable);
=>Applicable transport and storage conditions;
=>A unique number to allow identification of the delivery order; and
=>Assigned batch number and expiry date ( where not possible at dispatch, this information should at least be kept at receipt to facilitate traceability).
Returned :
[][]If any products undergo as expired or packet damaged which is not fit for use then record the product and stored in a separate area of the depot/warehouse with proper labeling following annexure– II under custody of depot in-charge.
[][]DIC will make an invoice of those products and sent to central warehouse after entry in the ERP to adjust the stock. Returned products will be sent to CWH at every three months interval.
[][]Head of distribution will collect this invoice/challan from different depots and sent to central warehouse after getting prior approval from Head of Sales & Head of Marketing.
[][]After receiving the returned products from different depots, in-charge, CWH will report to QA department along with the approved invoice/challan copy. In-charge, CWH will segregate the returned products according to their nature in a separate area with proper labeling as per annexure-II.
[][]QA executive will take actions following the SOP ‘Disposition of Returned Finished Products.
[][]In case of market compliant or product recall, DIC will inform to Sales or Marketing Department following the respective SOPs Head of distribution will collect the market compliant sample (s) or recalled product(s), batch(s) within seven days of initiation.
[][]Head of QA will take actions for the market compliant and product recall procedure following SOP.
[][]Stock verification of different depots will make through a physical audit by the representatives of Audit & Accounts department once in a year.
[][]A quality audit will be conducted for all the depots headed by QA representative once in a year.
Annexure:
Annexure I – Temperature monitoring record sheet
Annexure II – Returned product label