Training system for Aseptic and Preparation for Aseptic Operators and Support Staff
Introduction
This Complaint Handling guidance defines practices for establishing and maintaining a product quality complaint handling system, and for monitoring and reporting corrective actions based on the findings. Regulatory agencies and cGMPs in most parts of the world require a mechanism to capture, investigate and take appropriate action with regard to customer complaints. Handling of a complaint requires evaluation, investigation, and communication of the outcome to the complainant. The investigation of complaints related to product quality provides opportunities for improvement in customer satisfaction with products and services.
In addition to handling complaints, a system for reporting adverse events should be established. Timely communication of adverse events is required by regulations and product registrations in most countries. The complaint handling system should make provisions for analysis of trends and effectiveness of corrective actions.
1. Definitions
Complaint:
Any report of dissatisfaction (written, oral or electronic) related to the identity, quality, safety or effectiveness of any product manufactured or distributed. A complaint may be classified as a product quality complaint, adverse event, or both, and must be identified as such in order to facilitate proper handling and follow up by the appropriate group.
Product Quality Complaint:
Any possible failure of a drug product to meet any of its specifications. Quality complaints may be of a routine nature, or may be determined to be a potentially serious quality complaint allegation, and will be classified as an Expedited Complaint for the purpose of accelerating the complaint investigation and submission to the appropriate regulatory agencies and/or competent authorities, if necessary. Expedited Complaints include, but are not limited to: Allegations of tampering or mixed product sourced within the same manufacturing and/or packaging facility; alleged contamination; compromised integrity of a sterile product; or issues with product label causing product to be mislabeled or not properly identified. Any other issue that may represent a potential serious health risk to a patient/end-user may be deemed an Expedited Complaint.
Adverse Event:
Any sign, symptom or illness which is associated with the use of a drug or device. Adverse events which my be classified as ‘serious’ requiring expedited handling include, but are not limited to, an associated event which: results in death; is life-threatening; results in hospitalization or prolongation of hospitalization; results in persistent or significant disability or incapacity; or results in congenital anomaly or birth defect.
2. Complaint Handling System
All GMP manufacturing sites should establish a formalized program for the handling of customer complaints. A comprehensive complaint handling program should include the following elements:
- A written Standard Operating Procedure (SOP) for processing complaints;
- Individually numbered complaint files for each incident report received;
- When complaints are received orally, a system for documenting on the complaint form the information such that it is complete, factual and not editorial;
- Directions for handling the complaint samples in an appropriate and safe manner;
- Complete evaluation and documentation of results, including assessment of health risk, if any;
- Evaluation, documentation, and final disposition of the potential adverse event complaints.
- Review of relevant data and summary of findings to include a conclusion and/or corrective actions (with effective dates);
- Preparation of an appropriate response that includes results of the investigation;
- Review of the completed file, communication of the response to the complainant and maintaining a copy of the response in the file;
- Complaint files should be located in a designated area (accessible to the manufacturing area if kept offsite), and maintained according to the site’s record retention policy.
- Complaint review and analysis for trends should be conducted and reported to senior management and affected departments (Sales, Marketing, Production, Product Development, Legal, Packaging, etc.) on a periodic basis.
- Computer systems used for report management and/or trend analysis should be validated.
In addition, the appropriate regulatory agencies and/or competent authorities should be informed, when necessary, if the site is considering action following possibly faulty manufacture, product deterioration, detection of counterfeiting or any other serious quality problems with a product.
3. Complaint Files
A complaint file should be established for any written or oral complaint received by the site. Each complaint file that is opened should be assigned a unique identifying number.
4. Incoming Data
Complaints can come from a variety of sources, including, but not limited to: customer service representatives, sales representatives, consumers, healthcare professionals, retail customers, etc. Whatever the source, any employee or authorized agent who receives a complaint should promptly forward the relevant information to the group responsible for handling customer complaints. Effort should be made to obtain as much information as possible regarding the complaint. The information should include product name, description, package size, lot number, expiration date (if any), name of the person reporting the complaint, any patient or clinical information, appropriate complaint classification and sub-classification, and the nature of the complaint or event description (See attached Appendix II, Product Quality Complaint Contact Summary Sheet).
If a sample of the involved product is available, effort should be made to obtain the sample. All pertinent information should be entered onto a complaint form, or, in the case of a computerized system, directly into the system.
Appropriate rules and standards should be observed to protect the privacy of the complainant by limiting access to personal data recorded in the complaint files.
5. Complaint Samples
The sample should be properly identified with the complaint file number and stored in a designated secure area. If the samples are to be returned to the customer after evaluation, or if destructive testing is to be performed, consideration should be given to photographing the properly identified sample. Once the sample is evaluated it should be stored according to procedure.
If the complaint sample cannot be obtained, the investigation should be based on the information in the complaint report as well as any available product history. When the lot number is known, retained samples or samples from stock, or any batches on stability should be examined.
6. Investigation
The person responsible for handling customer complaints should evaluate the complaint and determine if an investigation is necessary. Any investigation conducted should be documented in a complaint report.
The rationale for not performing an investigation should be documented in the complaint form, signed by appropriate individual and included in the complaint file.
A typical Investigation Report should include the following information, as appropriate:
- Documentation of the Batch Record review
- Review of analytical records as indicated for atypical data
- Results of examination or testing of retention samples, product from stock, and/or stability samples
- Any information provided by the complainant that could aid in the investigation
- Review of lots produced before or after the subject lot
- Examination or testing of the complaint sample
- Review of the complaint database for trends pertaining to similar events, similar products, and/or similar materials.
- Documentation of any medical, legal, expert, or literature review.
- Any planned or completed corrective actions.
- Any other supportive or pertinent follow-up information for the investigation.
However, each complaint is unique, and should be investigated in a manner consistent with the risk presented by the complaint, and the specifics of the situation. All the aspects listed above may not be required for a thorough investigation.
Special attention should be given to establishing whether a complaint was the result of counterfeiting. For products manufactured at a contractor facility, the responsibility for handling customer complaints needs to be defined in the contractual agreements between the parties concerned. Records and sample retention programs should also be considered in these agreements.
7. Summary/Conclusion
After the evaluation and investigation of the product complaint have been completed, a brief summary of the complaint should be added to the file determining, where feasible, the most probable explanation for the cause. Appropriate corrective actions and persons responsible for the execution should be documented in the file. If no corrective action is required, a statement to this effect should be included.
8. Review and Response
After the complaint has been summarized and the conclusions documented, the entire file should be reviewed and approved by appropriate site quality personnel. The review should be signed and dated.
Whenever possible, a response letter to the complainant with copies going to the required sales/marketing departments and any other interested parties should be prepared and sent in a timely manner. A copy of response letter should remain in complaint file.
9. File Closure
When all information and documentation is assembled in the file, the complaint file should be closed. Each site should have a mechanism for timely file closure included in its complaint handling procedure. Typically, routine complaints can be closed within 30 – 45 days. Those complaints which require product analysis may take up to 60 – 90 days, depending on the nature and seriousness of the complaint. Outside resources may be required to complete a thorough evaluation. If complaint analysis requires more than the specified time frame for closure, an explanation should be added to the file. Under no circumstance should a file remain open for more than the specified limit without a reasonable explanation for the delay documented in the file.
Internal audits of the complaint handling process should be conducted on a periodic basis.
10. File Maintenance
Complaint files (and any associated samples) should be maintained in accordance with local legal and regulatory requirements, and the site record retention policy, as appropriate.
11. Training
All individuals involved in the complaint handling process should be thoroughly trained in the site standard operating procedures for consistent handling of product complaints.