by - OBJECTIVE
To lay down a procedure for prompt and effective recall of finished products known or suspected to be defective from Domestic and International Market.
2. SCOPE
This SOP is applicable to recall of unsatisfactory product from the market.
3. RESPONSIBILITY
| Recall coordinator | : | Co-ordinates all recall related activities |
| (Head- Quality) | : | Notification to regulatory agencies |
| : | Notification to Qualified Person and importers, where applicable. | |
| : | Reviewing of effectiveness of product Recall. | |
| : | Preparation of recall report | |
| Head- Distribution | : | Provide distribution list. |
| : | Facilitating Recall from all distribution point ensuring stoppage of further sale and distribution of suspected batch. | |
| Head QC | : | Provide analytical data related to RM, PM and Product |
| : | Plan & test the subjected batch/product and conduct investigation | |
| Head- Export market | : | Ensuring Recall complying with for international s regulatory requirements |
| Head- Legal | : | Liasoning with media in case of recalls. |
| Head store | : | Proper storage of Recalled products. |
| : | Destruction of Recalled Products |
4. ACCOUNTABILITY
Head Quality shall be accountable for the compliance of SOP.
5. Procedure
Head Quality shall initiate the recall process for any product. In addition to this, the recall may be initiated by competent authority e.g. Local drug authority or any other regulatory authority of export market or qualified person (QP) of the respective market.
Investigation of quality defect shall be investigated “Handling of Market Complaints. The investigation shall cover the following but not limited to:
Description of the reported quality defect
The determination of the extent of the quality defect. The checking or testing of reference and/or retention samples shall be considered as part of this, and in certain cases, a review of the batch production record, the batch release record and the batch distribution records (especially for temperature-sensitive products) shall be performed.
The assessment of the risk(s) caused by the quality defect, based on the severity and extent of the quality defect.
The decision-making process that is to be used concerning the potential need for risk reducing actions to be taken in the distribution network, such as batch or product recalls, or other actions.
The assessment of the impact that any recall action may have on the availability of the medicinal product to patients in any affected market, and the need to notify the relevant authorities of such impact.
The internal and external communications that should be made in relation to a quality defect and its investigation.
The identification of the potential root cause(s) of the quality defect.
Complaints concerning a possible defect are found to be correct and may cause a potential hazard to the consumer or user.
Represent a health hazard or suspected adverse event to the consumer or user.
Product/Label mix-up which may cause a potential health hazard to the consumer or user
Prepare an action plan.
Refer product development data, Specification and Test procedure for Raw Materials, Finished Products, Batch Production Records and Stability Data of suspected batch on immediate basis. Analyze retained sample of the finished product and raw material used for manufacturing the batch.
In case of suspected batch, take action promptly depending upon the degree of hazard and extent of distribution.
Head QA shall collect the information of suspected batch from electronic system and distribution information record.
Head Quality is the coordinator for Recall related activities and is responsible for execution of recall.
Head Quality or his designee shall initiate a meeting with Recall Co-ordination Committee members (RCC).
Details of Recall Co-ordination Committee members are given.
The Recall Co-ordination Committee shall evaluate all known information on the nature and extent of the reputed health risk and shall take into account but not limited to the following factors:
Whether any disease or injuries have already occurred from the use of product.
Assessment of hazard to various segments of the population. e.g. children, surgical patients etc.
Assessment of the degree of seriousness of the health hazard to which population at risk would be exposed.
Assessment of the likelihood of occurrence of hazard.
Assessment of the consequences (immediate or long term) of the occurrence of hazard.
Risk assessment shall be done as per the SOP for Quality Risk Assessment to identify the severity of risk involved.
Based on the nature of complaint, potential risk, health hazard, consideration shall be given to the concerned regulatory authorities/PL/ QP/MA, as to how far into the distribution network for recall action
The regulatory authorities shall also be informed in situations in which no recall action is being proposed for a defective batch because the batch has expired (such as with short shelf-life products.)
All concerned regulatory authorities should be informed in advance in cases where products are intended to be recalled. For very serious issues i.e. those with the potential to seriously impact upon patient or animal health, rapid risk-reducing actions such as a product recall may have to be taken in advance of notifying the regulatory authorities/PL/ QP.
Recall operations should be capable of being initiated promptly and at any time. In certain cases recall operations may need to be initiated to protect public health prior to establishing the root cause(s) and full extent of the quality defect.
5.1 Notification procedure for Recalls:
Head Quality shall send a Notification for recalls to the Head Distribution / Designee or Head- Export (in case of export product)Head Distribution / Designee shall contact all the key persons in the distribution chain through oral communication (Mobile phone, contact number) and or Fax/ E-mail.Based on the severity and potential risk, following notification & communication methodologies will be used:A: Notification and acknowledgement of receipt of Notification of recall immediately
within 24 hrs.B: Notification and acknowledgement of receipt of Notification of recall within 48 hours.C: Notification and acknowledgement of receipt of Notification of recall within 5 days.
In case of Export market, product recall shall be initiated in consultation with Ministry of Health & local agent.
5.2 Public Warning:
Incase of severe health hazard, Head – Legal shall issue a public warning through general News media and or professional trade or to specific segment the population such as physicians, hospital etc and alert the public that the said product recalled presents a serious hazard to health. Head Quality shall also intimate to the Drug authority/ regulatory agency/ PL.
In case of export, Head- export shall notify all competent authorities in respective countries and to the agent / importer where the product has been shipped. It shall be informed to country representative/ agent / importer as soon the decision for recall is taken. List of contact details of Qualified Person, MA and importer shall be maintained separately product wise.
Appropriate market-specific risk-reducing actions should be developed and discussed with the concerned competent authorities, if proposed recall action may affect different markets in different ways.
Head of Quality, Export and Distribution shall evaluate the effectiveness of the arrangement for specific recall on daily basis for recalls for severe risk, once in 3 days for moderate and once in a week for low risk, once the recall is ordered.
Received batches and Physician samples (If any), reconcile the recalled stock & ensure that all unit or pack of Batches have been recalled even from Hospital & Pharmacy Stores. Verify the Batch Documentation & reconciliation.
Store them in a specific space, labeled as “Recalled Products” in Store under Lock & Key with proper authorization.
A recall No. shall be allotted to each recall as PRC/YYNNN, whereas PRC stands for product recall, YY stands for last two digits of year and NNN is serial No. starting from 001in calendar Year.
Maintain a Register indicating all details.
Submit details of Recall. Status of Stock Recalled from Stockiest / Hospitals and result of Retained Sample to local Drug Authority and other Regulatory Agencies.
Keep all recalled Products till officially disposed.
Prepare a detailed report & submit to Local Drug Authority and or other Regulatory Agencies, with a request for permission of the Destruction of the Recalled Products.
Destroy recalled Products in presence of Local Regulatory Authority If required. In case of export product shall be destroyed in the exported country in the presence of local regulatory authority if required or in the presence of Galpha representative / importers if required.
Receive certificates regarding destruction & keep the records indicating termination of a product recall.
If the reason of drug product being recalled implicates associate batches, plan an investigation for those batches and identify other batches to be recalled.
Investigate the recall through CAPA if the problem was due to material, manufacturing, environment, analytical facilities or human Error, prepare an action plan for Preventive & Corrective actions to rectify the system. If the problem is associated with external factors, adequate and possible controls required to be employed.
Send the action plan to all concerned departments & Head Quality shall ensure that all action is taken within stipulated time frame.
A trend analysis and tracks of all the recall exercises are made at the end of the Year.
Refer Flow chart for better understanding of SOP.
The effectiveness of the arrangements for recalls shall be periodically evaluated by means of mock recall.
5.3 Mock Recall Trial Test
Carry out this test once in three years and shall be cover both within office-hour situations as well as out-of-office hour situations If any product is actually recalled as per above mentioned procedure within three years, there is no need to carry out mock recalls as the effectiveness of the arrangements of recall procedure shall be established from the records of actual recalled product.
If no actual product recall is made within three years, QA Head shall discuss with core committee person and take approval from senior management. After approval QA head shall initiate the mock trial test mentioned as below.
QA Head shall select any batch of any finished product which should be fast moving item having farthest distribution.
The batch selected shall have been distributed up to retailers.
Information shall be given to Senior Management regarding mock recall test and whole activity shall be kept confidential and the distribution people will not come to know that this is a mock recall. This will be informed to them at later stage e.g. after completion of mock recall activity.
After selection of product and batch, QA Head/ designee shall collect dispatch details from electronic software and collect in below format
| Date | Quantity | Ref. Doc. No. |
After receiving dispatch details QA Head/ designee shall collect distribution detail of this batch as per below format from Distribution Head / Marketing Head for Domestic. Govt. supply, Physician as well as Export supply)
| Sr. no. | C & FA/ Depot Name | Quantity | Dispatch Details | Contact Person | Email/ Phone |
After receiving the distribution detail, as per above format QA Head or his designee shall reconcile from distribution head or Marketing head as per below format
| Sr. no. | C & FA/ Depot Name | Dispatch Quantity (Nos) | Stock Status (Nos) | Sold By depot (Nos) | Break Up of Depot sale (Nos) | Sold to | De |
Distribution Head and/or Marketing Head (domestic and/or export) shall arrange stock statement from all stake holders as per above format.
QA Executive/Manager shall record this intimation in Product Recall Register wherein he/she shall write Mock Recall in Recalled Number, In column of product Name, with product name on which we perform Mock recalled and reason for Recall column mention to perform Mock Recall to verify the effectiveness of recall.
This exercise to be performed only to verify the effectiveness of recall but actual product recall not to be performed
After receiving stock statements from all stake holders, QA Head/designee shall fill up of Investigation report of Mock recalled and hand over the same to Quality Head for his review.
The Mock Recall is considered to be successful if all the records are accurate and the tracing back to the stockiest level is completed.
Quality Head shall review Investigation report of Mock Recalled and give his remarks and acknowledge the same and submit to Director. If any deficiency observed in the documents/records of any department shall be communicated in writing as well as discussed with respective head of the department.
After successful completion of Mock Recall QA head shall circulate the report to distribution Head as well as to senior management and same shall be recorded
6. TRAINING
Trainer : Head – Quality Assurance
Trainees : Staff of all the departments
7. DISTRIBUTION
Master Copy : Quality Assurance
Controlled Copy : Quality Assurance
8. ATTACHMENT
| Sr. No. | Annexure No. | Title | Format No. |
| 1 | NA | NA | NA |
9. REFERENCES
In-house
10. ABBREVIATION
| Abbreviation | Extended Form |
| EG | Engineering |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| WH | Warehouse |
| NA | Not Applicable |
| MB | Microbiology |
11. REVISION HISTORY OF CHANGE
| Sr. No. | Date | Revision Details | Revision No. |
| 1 | NA | New SOP | 00 |
