Recall Classification Mock Recall detail information.
Q: Why are Pharmaceutical Product is Recalled by pharmaceutical manufacturing companies?
Q: What is the Mock recall? How mush is Time limit set by FDA for recall?
Classification of Recall in pharmaceutical. Give procedure for doing mock recall.
Q: What is type1, 2,3 recall or What is Class A,B,C recall?
This article provides detail information and answers about recall classification mock recall in pharma and all above questions. It is always not that a medicine manufactured by a pharmaceutical manufacturing always meet the standard, or sometimes agencies like Food and drugs administration implement regulations to ban certain medicines time to time as per the recommendations and clinical trial outcomes are not favorable, sometimes pharmacovigilance reports that is drug adverse reactions are reported on a particular medicine, therefore companies take voluntarily, or due to regulatory actions, due to drugs not meeting standards in stability studies, degradation is observed , in such events medicines or drug, pharmaceuticals distributed by a company are withdrawn from sale and called back to pharmaceutical manufacturing company this event is called as recall. Recalls are basically classified as
1) Voluntary recall: recall initiated by a pharmaceutical company due to its own vigilance procedure or market complaint investigation.
2) Statutory recall: Enforced by Food and Drugs administration, Handling market complaint Product Recalls due to legal action, cancellation of license, unapproved product etc.
The procedures and timelines for recalling are very important, since not recalling a medicine that has adverse reactions reported, or class 1 type of recalled drug, will impact on the patient’s life.
Therefore, a pharmaceutical company has to have a very strong system, procedure for doing recalls of drugs products, in event any regulatory agency like Food and Drugs administration asks to do so or in event of a drugs fail in a stability test, or in event a drug reaction is reported, so as to protect the lives of people from the adverse reactions, and from substandard drugs.
The Food and drugs administration has clearly defined a time line for recalling drug products based on the classification of recall. 24 hours to 72 hours for class 1, or Class A, 10 days for Class 2 or class B, 30 days for class 3 or Class C.
There is a timeline for taking a decision within 24 hours by QA to recall the drug product upon noticing the defect or a communication of a regulatory agency from that the above timeline is required to meet is mandatory. A formal communication is required to be sent with all possible ways of communication for freezing of the available stock and recall of the same.
Recalls are classified as per the severity of the nonconformance of drug products. A drug product in question can be recalled completely, taken off from the market based on the severity.
What is type 1 recall or What is Class A recall?
A product which is not approved by FDA or a banned drug product, a product which has life-threatening adverse reactions reported in pharmacovigilance system, a drug product which has found to be defective while investigation of a market complaint, or while reviewing periodically the controlled samples if an adverse observation is there, then the drug product in question is recalled due to possible risks to patient’s life is classified as Class 1 recall or Class A recall.
Timeline for class 1 or Class A recall: Drug product recall classified must be withdrawn from market within 24 hours required it can be extended on satisfactory review upto 72 hours.
At which level it should be recalled: Class 1 recalled product must be recalled from retailer level and if possible from patient’s level.
A public notice is required to be published advising the general public for recall and not using the drug product which is in class 1 recalled.
Class 2 or Class B recall:
A recall is classified as class B in the event a drug product is found to be having moderate or temporary effect on the health of patients which is not serious, a drug product which is defective but does not pose a serious risk to patients is called back under Class 2 or Class B recall.
Timeline for class 2 recall: Drug products classified under class 2 or Class B recall must be withdrawn from the market within 10 days.
Class 3 OR Class C recall: When a drug product is found to be defective during market complaint investigation or any other mean, but the consumption of product by patient do not pose any risk to patient’s life but the quality of product is required to be maintained a defect of whatever nature is required to be removed from the market is classified as class 3 or class C.
Timeline for class 3 recall: Drug products classified under class 2 or Class B recall must be withdrawn from the market within 30 days.
Batch Recall: is a recall of a product where a particular batch of drug product is affected and other batches don’t have any problems and can be consumed by patients.
Lot Recall: A particular lot of a batch when it is not meeting the requirement or it is suited to recall it, is recalled from the market.
Mock recall, what is a Mock recall?: Due to mandatory requirements of recall time lines by FDA, the pharmaceutical manufacturing company has to review its systems, mechanisms for recalling a drug product, and check if it meets expectations of complete recalling the distributed product meeting the timelines depending on recall classification, mock recall in pharma is conducted.
Therefore, to validate an existing system or procedure for recalling pharmaceutical products, Standard operating procedure is prepared, and a product manufactured in that company is recalled from all possible levels as per class for which the recall drill is required to perform.
A batch or two are decided for recall, within 24 hours the decision is taken by QA.
QA entered in the recall log book and sign, after which, a communication is sent, by SMS, Phone call, or email, all possible means.
Goods are transported back to manufacturers, quarantined, labeled, and reconciliation is done for the qty. A review is done for the mock recall efficiency, the problems arisen during the mock recalls are noted and corrective and preventive actions are put in place for the problems.
After receipt of the recalled batch, QA initiates investigation as per the procedure for investigation of an incidence. Root cause of a defect identified is identified, a corrective and preventive action is taken over the same. A report on recall is prepared and submitted to the local Food and drugs administration or regulatory agency.