Time period for investigation after receipt of complaints:
Product quality complaints – within 5 days.
Packaging and quality complaints – within 10 days.
Medical complaint – within 3 days.
Complaint records shall be maintained at least one year after expiration date of medicines.
Complaint records shall be reviewed and a monthly summary shall be prepared for the management.
PRODUCT NAME COMPLAINT CATEGORY Batch no. Mfg.date expiry date Packaging/ product quality/ medical. Packaging details: Name / address of the complainant: Complaint reported through: Complainant sample enclosed: yes / no Quality of sample enclosed: Investigation report Total quantity involved PCR received by On: Investigation done by: Action taken Conclusion: Confirmed/not confirmed PCR no: PCR approved by: recommended corrective actions
It is important to have open channels with with customers in order to receive their suggestions, doubts and complaints. Generally, these channels are toll-free numbers, e-mails, chat-rooms and P.O. boxes.
The most flexible channels are toll-free numbers and chat-rooms.
A person must be appointed in charge of receiving complaints and inputting them into appropriate investigation form that shall be addressed.
It consists of requesting the Quality Control (QC) laboratory to analyze.
Complaint samples are the customer sample.
Retained samples – the reserve samples representative of the lot manufactured (which were kept under appropriate conditions of temperature, humidity and light so that the drug product was not affected).
The company elects a person in the QA unit to be in charge of technical investigation of each complaint, e.g. a Complaint Officer.
When both complaint and retained samples showed out-of-specification (OOS) results or when only the complaint sample showed OOS results.
a single unexplained failure may be when one tablet is missing in the intact blister strip in the complaint sample, but no deviation was found in the retained samples or during the in-process controls and final QC analysis recorded in the batch record.
When both complaint and retained samples showed results in compliance with specifications or when only the complaint sample showed OOS results.
OOS results in a complaint sample can be attributed to misuse or mishandling, when the drug product was not kept under appropriate conditions of temperature, humidity and light so that the identity, strength, quality and purity of the drug product could be affected.
Tablets of the complaint sample show a change in their appearance that is characteristic of a light, humidity or high temperature exposure.
When the retained sample is within the specification but the complaint sample is clearly OOS with no reason for that, such as a counterfeit or tampered drug product.
when packaging material is different from the original; an example of tampering is when the color of the drug product is completely different from the original or when any foreign substance was added to the product.
For all confirmed complaints, corrective actions must be implemented. These actions can range from a simple and quick training to some employees to a formal Corrective Action and Preventive Action (CAPA) handling.
If a CAPA is opened, a multidisciplinary team consisting of representatives of QA, QC, Regulatory Affairs and Production Management must be established.
Concerning non-confirmed complaints originating from misuse or inadequate handling of the drug product. The customer should receive a written response together with scientific information on the correct use and handling.
As feedback to the customer, the company must write a response letter to the complainant to explain the investigation approach taken, the results obtained and any implications, in case the quality problem was confirmed.
The customer should be sent a free replacement product together with the response letter, since the customer returned the product (the ‘complaint sample’) to the company for analysis and a quality problem was found.
‘‘ Recall’’ means a firm’s removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure.
The main objectives of this recall plan are:
Stop the distribution and sale of the affected product.
Effectively notify Management, customers and regulatory authority.
Efficiently remove the affected product from the marketplace, warehouse and/or distribution areas.
Dispose and Conduct a root cause analysis and report the effectiveness and outcome of the recall.
Implement a corrective action plan to prevent another recall .
Formulating a proposed recall strategy . It specifies the nature of communication to be used (phone, fax, telegram, letters, telemail, etc) as well as the level in the distribution chain to which recall is extended.(wholesalers, retailers, public, etc).
Relevant records shall be submitted to regulatory authorities with proposed plan of action.
INDIAN PHARMACEUTICALS LIMITED
Medicine recall control document
3. RECALL STRATEGY
3.1. Nature of communication (phone, fax, telegraphs, letters, news papers, etc.) __________________________________________________ __________________________________________________
Depth of recall: (Wholesalers, retailers, general public) __________________________________________________
GM, QA/QC Regulatory or GM manufacturing shall prepare a “ Standardized recall letter” and “press statement”.
INDIAN PHARMACEUTICALS LIMITED
STANDARD RECALL LETTER
It has come to our notice (product name) _______________ having batch number ______________ or has shown ________ please refrain from prescribing or dispensing any of this batch number and return all your stock of this batch number to our office at: __________________________________________
All returned stock or this batch number will be replaced as free of charge. We apologies for any inconvenience caused to you and thank you for your co-operation.
Recall is an effective method of removing or correcting consumer products that are in violation of laws administered by the FDA.
Recall may be undertaken voluntarily and at any time by manufacturers and distributors, or at the request of FDA.
Recall is generally more appropriate and affords better protection for consumers. Seizure, multiple seizure, or other court action is indicated when a firm refuses to undertake a recall requested by the Food and Drug Administration.