1.0 PURPOSE
To lay down the procedure for Product recall.
2.0 SCOPE
2.1 This SOP is applicable for Active Pharmaceutical ingredient.
3.0 RESPONSIBILITY
3.1 Manager – Quality Assurance
3.2 Manager - Marketing
4.0 ACCOUNTABILITY
4.1 Director
5.0 PROCEDURE
5.1 Batch shall be recalled from the market, in case product cause health hazards or may be the potential health hazards or due to directive form any regulatory authority to recall the product.
5.2 Ascertain the seriousness of health hazards caused by the product and its consequences. The seriousness is classified as:
Class A: Product causing health hazards or even death.
Class B: Product causing temporary health hazards or sometimes
no serious hazards.
Class C: Product not causing any serious hazards.
5.3 The current location of the particular batch of the product are traced through distribution record of the distribution department.
5.4 In case Active Pharmaceutical Ingredient (API), the company is asked to recall their batches marketed, manufactured using the bulk batch, which is in question. The effective product recall is done as per following guidelines.
5.4.1 Based on the complaint received from the market, Head-QA shall decide for the requirement of recall in consultation of Head-Production and Head-Corporate Quality Assurance with due approval from Director as per Annexure I.
5.4.2 The Head- Quality Assurance shall immediately inform the Head of Marketing through Telephone, Telex, Fax, E-mail and inform him to stop sale of the batch. He shall follow this up with a written communication vide Product Recall Report and Recall Return Card.
5.4.3 If the recall is confined within India, then recall request shall be sent to all Depot locations by Fax/Registered letter/Courier service/ E-mail with intimation to the Drug Control Authority. If the batch to be recalled has been exported, the respective Regional Director/Country Manager shall be informed by Fax/Courier/E-mail to recall the batch. The Director/Country Manager shall send the information to the regulatory agency of the importing country.
5.4.4 Quality Assurance Manager shall also fill-up a Recalled Checklist, as per Annexure – II and update reconciliation of recalled stock on weekly basis.
5.4.5 The recalled product shall be identified and stored separately in a secure way while awaiting a decision on their fate.
5.5 Head – QA shall investigate the cause of failure leading to product recall and recommend the corrective action.
5.6 The records of product recall and destruction of recalled batch is kept with Head – QA.
END OF DOCUMENT
Product recall, quality assurance
