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Wednesday, May 12, 2010

STANDARD OPERATING PROCEDURE Title: “Recall of Product”

1. PURPOSE
1.1 It is established for the establishment of procedure for recall of finished product from Market.
2. SCOPE
2.1 It is applicable to all products in market suspected or found to be defective.
2.2 Any packs returned from patient to the pharmacy will not be accepted.
3. RESPONSIBILITIES
3.1 General Manager Production
3.2 Manager Quality Assurance.
3.3 Assistant Manager Quality Assurance.
3.4 Manager Stores
3.5 Marketing Manager
4 PROCEDURE
4.1 Reasons for recall
1. Any complaint from market regarding quality & which after evaluation by QC is found to be justified.
2. Any observation from within the organization regarding quality & which after evaluation by QC is found to be justified.
3. Any product which is 6 months near to expiry date.

4.2 Initiation for recall
1. In case of 1st reason for recall, Marketing Manager receives the complaint from market, documents its detail (Date, Name of Complainer, address, nature of complaint, frequency of complaint, Product name, strength, batch no, Mfg date & Expiry date, any other necessary information) on Inter office memo & sends it to Quality Control Manager along with the sample of the product.
2. In case of 2nd reason for recall, Quality Control Manager informs Marketing manger about the nature of problem, Product name, strength, batch no, Mfg date & Expiry date, any other necessary information on Inter office memo.
3. In case of 3rd reason for recall, Marketing Manager will write to the distributors to submit information of their stock level for that particular product & after receiving the same intimate to the Quality Control Manager.
4.2 Execution of recall
1. If Quality Control Manger with consultation of Quality Assurance & Production comes to the conclusion that product is not of stated/intended quality and/or it may affect the patient or his compliance to the product he immediately writes to Marketing Manager to recall the product from all of distributed areas.
2. Marketing Manager writes to all of the distributor to dispatch the product stock to the Factory premises within the specified time period addressed to the Manager Stores (Finished Goods).
3. Manger Stores (Finished Goods) receives the stock & quarantine it in the specified quarantine area being product in its original packing.
4. Manager stores (Finished Goods) verifies the quantities & identity of the product.
5. If product is not near expiry date, Manager stores sends request for analysis to the Quality Control Department.
6. Quality assurance department samples the product & sends to QC.
7. In case product is not identified regarding its Batch No., Mfg. date, identity or strength (in case if more than one strength registered) it will never be sampled & will be rejected in straight.
8. Quality Control department subjects the product to analysis & may suggest
a. The product reprocessing
b. The partial destruction of the quantity
c. The complete destruction of the product.
4.3 Product reprocessing
1. In case reprocessing is recommended by QC, Quality report to store clearly indicates the same. One copy of quality report is sent to Production Manager.
2. Production Manager intimates the same to the relevant section head.
3. Section head raises the request for issuance of recalled product to the store & after verifying the quantity receives the stock.
4. If required, new batch number is allotted to the reprocessed product in such a way that the parent batch number is identified as being reworked.
5. After reprocessing is completed product is transferred to the store on Batch transfer note indicating clearly the new batch number & the previous one. One copy of this note is attached with the parent batch file.
4.5 Destruction of recalled product
1. If QC department after necessary testing activity comes to the conclusion that no reprocessing is possible or there can be no identification of the Batch number of the product & destruction is recommended by the QC department the Manager stores raises the “Destruction Note” clearly indicating the reason for destruction & quantity thereof; he sends this note to QA department.
2. QA department receives the stock & destroys it in the presence of deputed QA person.
3. Destruction of recalled Vaccines:
a. Vaccines are destroyed in manner that assures there remains no life in the product.
b. Secondary packing of the packs is removed off & packs are arranged in autoclave box and sealed completely.
c. Subject the product to autoclaving at 1210C for 1 hour.
d. After autoclaving packs are opened & buried the contents in soil.
e. Primary packing components (glass vial, ampoules etc) are not reused & broken away.
4. Destruction note is duly signed by the deputed QA officer, QA Manager & is filed in the parent batch file.
5. Quality Control manager intimates in writing to Marketing Manager about the action taken towards the reprocessing or destruction of the stock.

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