SOP : Incoming Inspection
Version 1
Biz-Partner Group Co.,Ltd
SOP Title Incoming Inspection
Date of
17 January 2020
Issue/Implementation
Written by Name: Phyo Wai
Position: Business Manager/Service Operation Manager
Date: 17- 01- 2020
Signature:
Name: Mr.Sithu Aung
Position: CEO
Date: 17-01-2020
Signature:
Approved by
Version Number Version 1
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SOP : Incoming Inspection
Version 1
1. Objective
The purpose of this SOP is to provide for instructions and to assign the responsibilities for the
receiving inspections of the products from oversea suppliers.
2. Scope
This SOP applies to all analyzers, components and temperature based reagents that are shipped
from manufacturers to be stored in the ware house for onward distribution to the markets
nationwide.
3. Responsibility
Store person performs inspections of goods shipment.
QA Manager communicates any request for product disposition and records all the applicable
supporting information.
Business Manager co-ordinates the disposition activities and follows up on potential corrections.
4. Procedure
Incoming Goods
- Check and record the product name, item code, batch/lot number and expiry dates.
- Record quantity received against order, name and address of the supplying site.
- Examine containers for tampering, damage or contamination,
- Do not accept products that have expired or which are so close to their expiry date that this
date is likely to occur before use by the consumer,
- Inspect status of any attached temperature recording device(s) and/or time/ temperature
indicators and verify that required storage and transport conditions have been maintained.
- Enter product details, including product name/number, strength, batch numbers, quantities
received, expiry dates and acceptance status into the stock recording system.
- Store checked goods under the correct temperature and security regime immediately upon
receipt.
- Quarantine defective or potentially defective products, products with incomplete or missing
paperwork, products that experienced unacceptable temperature excursions during
transport, or products suspected to be counterfeit.
- All unacceptable temperature excursions should be evaluated to determine their effect on
the product.
- Report any defects to the supplier.
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SOP : Incoming Inspection
Version 1
- Do not transfer to saleable stock until all relevant disposition procedures have been
completed.
Outgoing Goods
- Transport vehicle conformity is checked before loading goods.
- Expired products are never issued. Products with short expiry dates are not issued unless
the recipient accepts that they can be consumed before the expiry date is reached.
- Details of any temperature monitoring devices packed with the external distributions are
recorded.
- Details of outgoing products, including product name/number, strength, batch numbers,
expiry dates and quantities distributed, are entered into the stock recording system.
- The delivery report should be signed by customers to assure the goods arrival status so that
the appropriate action can be taken in the event of returns, recalls or complaints.
- Records are maintained to provide evidence of the conformity, implementation, and
effective operation of the quality management system.
- All records are required to be legible, accurate, readily identifiable and appropriately
retrievable.
- Capturing a record is achieved by placing it within a structured filing system, either in a
paper based or electronic record system. In this way the document is connected to other
documents providing context for the person who will subsequently retrieve the information.
- Records are identified with a descriptive title that clearly labels the records.
- Each record is assigned a unique name, a reference number or alphanumeric identification
to distinguish it from the other records.
- Records should be saved in the files and prevent duplication.
- When file covers have been worn out, they must be replaced to ensure effective protection
records.
- Records are disposed when the retention time has been exceeded. Disposition may be to
discard or destroy the records or to put them in long-term storage.
Stock Management
- Using i-Stock for stock management system.
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SOP : Incoming Inspection
Version 1
- Authorize persons (Finance Manager & Assistant) record all receipts and dispatches.
- Record batch numbers, expiry dates, short-dated and expired products.
- Record product status (i.e. released, quarantined, hold, reject),
- Record all product returns, recalls, withdrawals, damage and disposals.
- QA takes regular physical inventories and FM reconciles stock records with the actual
physical count.
- Investigate and report on stock discrepancies in accordance with agreed procedures.
- Physical count is made at least twice a year.
- Carry out regular audits and make audit reports available to the responsible authorities.
- Comply with all record-keeping procedures specified in local regulations. Retain product
transaction and delivery records for at least the minimum time period required by local
regulations.
Product Return Procedures
- Quarantine returned goods in a suitable temperature-controlled area and under the security
conditions applicable to the product type.
- Do not return to saleable stock unless storage and transport temperature conditions after
dispatch from the distribution site have been fully verified and documented, including the
return leg to the distribution site.
- If returned stock is re-issued, distribute in accordance with the exposure status of any
product-mounted time-temperature indicator device.
- Quarantine returned goods that have been exposed to unacceptable storage and/or
transport temperatures and mark for disposal.
- Maintain records of all returned goods.
Product Recall Procedures
- Conduct urgent and non-urgent goods recalls in accordance with an agreed emergency plan.
- Notify overseas regulatory counterparts where the product has been exported.
- Notify all affected customers as applicable.
- Quarantine any remaining inventory of recalled goods and mark for further investigation
before disposal.
- Maintain records of all goods recalls, including reconciliation of quantity sold, quantity
returned, quantity remaining or quantity consumed.
Product Disposal Procedures
- Ensure that rejected and/or recalled or withdrawn goods cannot be used, released or cause
contamination to other products.
- Store separately from other products, in accordance with local regulations, to await
destruction or return to the supplier.
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SOP : Incoming Inspection
Version 1
- Safely dispose of rejected and/or recalled/withdrawn products in accordance with local
regulations, including where relevant, regulations covering the disposal of hazardous and
controlled drugs.
- Maintain disposal records.
Quarantine Area
- Provide a quarantine area for the isolation of returned, faulty, recalled and otherwise
withdrawn goods pending a decision on disposal or re-stocking by the QA.
- Items for re-stocking, testing and disposal should be kept separate to avoid the risk of
inappropriate use.
- Materials within quarantine areas must be clearly identified with their status:
— with temperature control, for items returned for re-stocking;
— with temperature control, for items recalled for testing;
— without temperature control, for items awaiting disposal.
- The quarantine area may be a physically separated zone, or it may be defined using a
suitable stock control information system, or by a combination arrangement.
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