QMS-055 Pharmaceutical Product Complaint Procedure

Document Owner

Quality Assurance Manager

Affected Parties

All Manufacturing Employees

Purpose

This procedure descries the process to ensure that product manufacture are documented, evaluated, monitored, reported, and trended in accordance with regulatory and corporate requirements.

Scope

The scope of this procedure covers receipt, logging, evaluation, investigation and reporting of all complaints received by the GMP site’s Customer Complaint and Quality Assurance Departments.

Definition

Related Documents

EHS Statement

All Complaint procedures will be conducted in accordance with appropriate EHS procedures.

Procedure

1.            Receiving a Complaint

See Flow Chart (Appendix 1).

1.1.         A designated telephone number is available to all customers as the contact point for all enquiries, including complaints. All incoming calls on this number are handled directly by the Customer Service Representative who will maintain an active liaison with the relevant marketing team.

1.2.         The complaint details are entered onto the Customer Service Database. The details of the complaint will be documented in the Complaint Details Form (Form-465). Each complaint is given a unique compliant reference number which is entered into customer service complaint database as well as into the Complaint Reference Form. The complaint number is made up of four sections.

For example:       XXX-YYY-ZZ-AA

Where,

XXX     –           represents total complaint to date

YYY     –           represents total complaints by product

ZZ        –           month of the complaint is registered

AA        –           year of the complaint is registered (Last two digits)

1.3.         Site personnel other than the Customer Service Representative (i.e. Sales representatives) who receive a complaint, should take down details, including product name, expiry date, batch number, and the caller’s name, address and phone number and forward to the Customer Service Representative for action without delay.

1.4          The complainant will be asked to return the product subject to the complaint. The name and address of the complainant should be obtained at this time.  The Customer Service Representative sends a covering letter to the relevant retailer or complainant explaining the complaint handling procedure, a replacement product and a Reply Paid Bag for return of the sample. Details of replacement product are recorded on the letter to the nominated recipient. The decision on replacement may be delayed in exceptional circumstances until the results of testing are known.

1.5          Only one Batch number per Complaint will be logged in. Customer Service Representative has to ensure the followings:

If the customer has returned two or more samples and they are of different batch numbers, these must be logged separately.

If the customer has returned multiple samples of the same batch number, but clearly indicates that there is more than one complaint, then these issues must be logged separately.

If the customer has returned multiple samples of the same batch number and clearly indicated that all are for the same issue, then these are be logged as one complaint.

1.6          The package containing the complaint form (Form-465) and sample is send to the Quality Assurance where the details are checked and an evaluation of the product can be made.

2.            Evaluation of complaints

After getting the Complaint Details Form and the samples, the QA Staff has to initiate the following things:

The initial evaluation of complaints

Create a QA complaints spreadsheet and enter details of the complaint in the file

Determine the investigation plan and send the complaint samples to either in Production, Laboratory or other contract manufacturers as appropriate.

Ensure the complaint investigation and documentation is completed within the time frames.

The Area Managers or Laboratory Manager should be responsible for giving the complaint sample to appropriate staff for investigation with necessary directions (i.e. Finished Product specification or control method) and to finish within the specified time. They have to ensure any corrective action is taken to rectify problems identified.

2.1.         Initial Evaluation

To be read in conjunction with Appendix 1.

2.1.1.     QA Staff has to read all information available in the Complaint Details Form concerning the particular complaint.  Ensure that all information entered in the form is correct, and make necessary changes if it is not.

2.1.2.     Check batch number details for all parts of the product returned.  The product and the outer packaging may have been interchanged.  If the batch numbers are different, then use the batch number of the actual product or unit.  Enter details into QA Complaint spreadsheet like Expiry Date, product Code and Box Number for storage of sample after evaluation.

2.1.3.     Enter information relating to the quantity and condition of product received, e.g. number of units, containers are whether full, empty, used, opened, sealed or damaged,.  (This is very important, especially if tampering with the product is suspected.)

2.1.4.     Label the returned product securely with the Complaint Reference Number quoted from the Complaint form (Form-465) and the Storage Box Number on all sections of the complaint sample that are able to be separated e.g. Outer packaging.

2.1.5.     For suspect counterfeit or tampering complaints the chain of custody needs to be maintained.  Refer to section 7 of this SOP.

2.1.6.     Determine if the complaint is critical, serious or standard.  If the complaint is critical in nature inform the QA Manager, or delegate.  Complaints should be worked on in order of severity, (i.e. critical complaints get highest priority).

2.1.7.     Determine the Site of manufacture.

a. If the product has been in-house manufactured, go to section 2.2.

b. If the product has been imported or contract manufactured, go to section 2.3.

2.2.         Complaints for In-house Manufactured Goods

To be read in conjunction with Appendix 2.

2.2.1.     Review the old complaints in the QA Complaint Spreadsheet to determine whether a similar complaint has been received.

2.2.2.     If a similar complaint is identified, review the previous report to determine whether the same cause is applicable and whether any preventive actions had been implemented prior to the manufacture of the batch.

2.2.3.     If preventive actions had been previously implemented but they have not been effective in preventing the recurrence, an investigation will be necessary.

2.2.4.     If preventive actions have been implemented subsequent to the manufacture of the batch, no further investigation is required.

2.2.5.     Determine if the issue is supplier related or process related.

If supplier related, forward the sample procurement with all necessary information to follow up with supplier (within 2 days of receipt of sample)

If process related, forward the sample to the Area Manager to follow up with the Team (within 2 days of receipt of sample).

Determine if laboratory testing is required.

2.2.6.     In case of process related issue, the Area Manager has to review relevant logbooks and seek feedback from team members in an attempt to identify potential causes.  Process Data Collection Form (Form-570) may be used to gather this information.  This information is returned to QA Staff investigating the complaint within 1 week time.

2.2.7.     Laboratory testing may required for either microbiological and/or chemical.  If laboratory testing is justified, the QA Staff has to:

Forwards sufficient samples (Complaint sample and Retention samples from the same batch number) for testing with Result Recording Form (Form-490)

Send all relevant complaint information

Obtains specification/controlled test methods for the product code.

If retention samples are to be tested, they should be procured by following SOP LAB-045.

2.2.8.     Complaint Samples which are believed to be counterfeit are tested for compliance to specifications as per section 7 of this SOP.

2.2.9.     When analysis is complete, the analyst is to record the results on Form-490 and return to the QA Staff for review as soon as possible.

2.2.10.  The QA Staff will review the batch documentation, including MI sheets, Analytical documentation for compliance to specification and any deviations that may be relevant to the complaint.

2.2.11.  All information gathered will be reviewed by QA Staff to determine whether the complaint is justified or not.  If the complaint is not justified document findings in the report and circulate it for approval.  Use Customer Complaint Investigation Report Form (Form-405) to document the investigation.

2.2.12.  If the complaint is justified, a root cause (and contributing cause(s) where relevant) needs to be identified and appropriate corrective and preventative actions will be assigned to prevent recurrence of the problem. These are to be documented in the Customer Complaint Investigation Report Form (Form-405), including responsibilities and timeframe for completion.  The investigation findings will be entered into QA Complaint spreadsheet.

2.2.13.  Circulate the report for approval. One copy approved report will be forwarded to the Customer Service Representative. The original report will be filed in QA Office.

2.3.         Imported or Contract Manufactured Complaints

To be read in conjunction with Appendix 2.

2.3.1.     The process for Imported or Contract Manufactured complaints is very similar to locally manufactured complaints. The difference is that the responsibility for investigation is for the contract manufacturer.

2.3.2.     For Investigation by Contract Manufacturer, forward sample with covering letter detailing the complaint and results of initial evaluation to designated contact.

2.3.3.     Keep track of complaints with the contract manufacturer so that they will be analyzed and reported within the specified time frames.

3.            Storage of Samples

The QA Staff is responsible for the storage of samples using the following process:

3.1.         Disposal of samples takes place as set out in SOP LAB-045.  Samples are to be kept for one (1) year past their expiry date.  Boxes are kept in designated Complaint Storage area in the retention Sample Room.

3.2.         The system in place allows for samples to be stored in numbered boxes that can be easily discarded at the end of the storage period.

3.3.         The boxes are numbered and clearly labelled “Complaints, Box Number —, “To be discarded in December XXXX” (the appropriate year for sample disposal).  Details and allocation of Box numbers are recorded in the table QA Complaint Spreadsheet:

4.            Trending of Product Complaints

4.1.         The Quality Assurance staff reviews the data entered into an Excel Spreadsheet for Customer Complaint, periodically to determine if there are any unfavorable trends in the Complaints Data.

4.2.         The data is analyzed based on the following criteria:

Process Line (for In-house manufactured goods)

Product Code

Date of Manufacture

4.3.         The data will be sent to management for review and copy of the data will be held in QA files under “Quarterly Complaints Trend Review”.

4.4.         Any unfavorable trends will be discussed in the Quality Meeting with the view to generate Continuous Improvement Plans and Preventive Action Plans to reduce the level of complaints received for the issue identified.

5.            Handling of Suspect Counterfeit Samples and Product Diversions

5.1.         A sample will be suspect if there is reason to believe that:

a. A counterfeit product and/or pack

b. Product that has been tampered with

c. Product that has been diverted from the normal supply chain.

5.2.         A written and documented record (Chain of Custody) of the history and movements of the suspect sample to support any legal prosecutions has to be initiated and maintained with sample by the designated QA Staff if a suspect sample is received and should include the following information:

5.2.1.     Details of sample, which include the reference number, details of time and place of acquisition of sample and the acquirer, must be noted on a form or in a notebook which is kept with sample.

5.2.2.     Sample is to be placed in a sealed, preferably transparent plastic envelope that is securely sealed.

5.2.3.     If the envelope has to be opened, then the person, who is at that time in possession of the envelope, shall record in the notebook or forms, the details as to why it was opened, the time and date, who was present and when the envelope was resealed.

5.3.         QA management will inform the supply chain manager that a suspect sample has been received at site and initiates the investigation which includes the following steps:

5.3.1.     Determines the site at which sample should be investigated and securely forwards sample to manufacturing site with the Chain of Custody form if appropriate.

5.3.2.     For samples investigated in house, the following are suggestions for the examination of suspect samples:

5.3.2.1.   Examination of the Pack

1.   Visually check pack against “market pack” and for pack completeness.

2.   Dimensional characteristics.

3.   Artwork comparison which includes the following:

a. Wrong or extra wording

b. Stickering / Overstickering / Hand Stamps

c. Color variation

d. Company logo

e.  Font differences.

4.   On-line Data which includes the following:

a. Confirm batch/lot number

b. Confirm batch/lot number/expiry date match

c. Differences in application of the variable data, (e.g. Printing/embossing)

d. Standards of presentation of variable data.

5.3.2.2.   Product Examination

a. Non-Destructive Testing

b. Dimensional characteristics

c. Appearance, intagliation, color

d. Destructive Testing (i.e. Assay)

6.            Reply to complaints

6.1.         It is the responsibility of the Customer Service Representative or Manager to write a response, have it reviewed and signed off by Marketing and Customer Service Manager and send to the customer within four weeks of receiving a complaint.

7.            Appendix 1: Product Complaint Initial Evaluation Flowchart

8.            Appendix 2: Locally Manufactured Complaints Flowchart

Summary of Changes