Follow
1.0 OBJECTIVE
To describe a procedure for handling market complaints and take appropriate corrective action to address the complaint as well as to prevent a recurrence.
2.0 SCOPE
This procedure is applicable to all types of market complaints that are related to quality, packing, and/or shortage of units of products manufactured at (Company Name) and received directly either from the market or from distribution agent or patient. This procedure is not applicable for complaints regarding adverse events or adverse drug reaction.
3.0 RESPONSIBILITY
3.1 Marketing department shall be responsible to share the complaint as received, with appropriate details and samples (if any) to Head, Quality or designee.
3.2 QA Manager or designee shall be responsible to register the complaint, carry out necessary investigation, implement appropriate corrective actions, provide technical response to Marketing department in consultation with Head, Quality, generate the complaint report and close the complaint.
3.3 QC Manager shall be responsible for carrying out the analysis of samples as per requirement.
4.0 ACCOUNTABILITY
4.1 Head, Quality.
5.0 PRECAUTIONS
5.1 Any compliant regarding the safety of the product, involving an adverse event and/or adverse drug reaction must be informed immediately to Safety officer- Corporate PV at pharmacovigilance@bpl.net.
6.0 PROCEDURE
6.1 Definition of Market Complaint
6.1.1 A written report or verbal communication originating from customer, retailers, physicians, field supervisor, regional sales coordinator, Medical representative, hospitals, regulatory agencies or from employees of (Company Name), that relates to an inadequacy of quality i.e.: noncompliance with standards or customer requirements and includes a packaging and labeling requirement, a query regarding specifications, analytical procedure or incomplete text, must be treated as a complaint.
6.2 Classification of Complaints Market complaints will be classified as minor, major and critical.
6.2.1 Minor: Complaints related to the physical appearance of packing of the product.
6.2.2 Major: Complaints related to physical appearance of the product like, broken tablets, fading, spots etc., packaged quantity which may include but not limited to empty blister, empty cans, broken/missing actuators, empty content etc., missing label, missing batch printing etc.
6.2.3 Critical: Complaints related to the chemical property including but not limited to chemical test failure of the product, like, low purity, change in the impurity levels, degradation of the product, complaints arising due to stability failure etc. In the event of a batch being considered to be actually or potentially harmful to the patient, thereby requiring a recall, follow procedure 6.12.11 detailed in this SOP.
6.3 Types of Complaints:
6.3.1 Shortage: These types of complaints include empty blister, empty bottles, shortage in blister, shortage in bottles, empty inner carton, shortage in shipper etc.
6.3.2 Packing: All packing and labeling problems including but not limited to undesired printings, changes or damage of packing or labeling, discoloration of labels or packing, mudding, manufacturing and / or expiry date missing, Market Retail Price missing, Registration No. missing, problem with physical appearance etc.
6.3.3 Quality: All problems related to identity, strength, quality, potency, purity of the product which will include low purity, changes in the impurity level, degradation of product, stability failure etc.
6.4 Any market complaint received by marketing / sales team from customers or identified by the marketing team, must be communicated to Head, Quality using the market complaint form (Annexure-IV) along with all relevant complaint details, including original complaint document, if applicable. If details of the complainant are not available in the document, then details of the retailer or recipient from where the complaint has been received must be recorded in the market complaint form.
6.5 Head, Quality or designee shall send the market complaint form along with complaint sample, if received, to QA Manager for conducting an investigation and generating a comprehensive report .
6.6 Complaints directly received by Head, Quality with regards to quality of product or other technical related issues, shall be informed to marketing and handled as per step 6.5. Refer flow diagram in (Annexure-V).
6.7 When a complaint received is related to safety of the drug like adverse events or adverse drug reaction, then assess the validity of the complaint as per step 6.8 and share it to pharmacovigilance@bpl.net (Safety officer – Corporate PV, Telefax: 0088029664449).
6.8 Consider a complaint valid from a Pharmacovigilance perspective, if the following four information are available.
6.8.1 Patient identifiers, which would include initials, sex, date of birth or age.
6.8.2 Description of symptoms and diagnosis (if possible).
6.8.3 Suspected Product(s) (Strength, lot number, expiration date).
6.8.4 Reporter’s identity (Including contact details for follow up)
6.9 Complaints related to adverse events and adverse reaction will be dealt as per SOP for ‘Handling of adverse events and safety information for marketed products’. (SOP No.: PV002).
6.10 Investigation of Complaints
6.10.1 Record details of the complaint in a ‘Market Complaint logbook’ (Annexure-II). This must include Name of the Product, Batch No., Manufacturing and Expiry Date, Description, Type and Classification of Complaint, Name & Address of Complainant and Date of receipt at the investigating site.
6.10.2 Assign the complaint number as MCR/ABC/XX/YYY;
Where,
‘MCR’ represents Market Complaint Report
‘ABC’ represents the facility where the complaint product was manufactured, i.e. OSD, MD1, MD2, DPI, etc.
‘XX’ represents the last two digits of the year e.g. 16, 17, etc.
‘YYY’ represents for sequentially increasing number e.g. 001, 002, 003,……. for the year XX.
Each code shall be separated by a slash (/)
6.10.3 Basis the investigation conducted, Manager, QA or designee shall conclude the nature of the complaint as ‘Substantiated’ or ‘Unsubstantiated’.
6.10.4 Once the investigation is completed, a comprehensive report is generated, and necessary corrective and preventive actions (CAPA) as deemed fit, are put in place to avoid recurrence of a similar complaint.
6.10.5 When the complaint is considered as closed, Manager QA or designee will enter the status as ‘Closed’ in the ‘Market Complaint log book’ with sign and date.
6.10.6 If the complaint sample is received along with the complaint, record the quantity of sample received in the market complaint investigation form (Annexure-I).
6.10.7 In the event of the sample being required to investigate the complaint, request the marketing /sales department or the complainant to share the complaint sample.
6.10.8 The investigation will be delayed if the requested sample is not received. If in spite of repeated requests (2 requests) the complainant or the marketing/sales department is not able to provide the sample, the complaint shall be considered as ‘Complaint without sample’ and the investigation report shall be closed.
6.10.9 If a complaint sample is not received along with the complaint, this shall be recorded with other details in the complaint form.
6.10.10 Detailed investigation of the market complaint will be conducted by forming a cross functional team, which will include a personnel from Production and Quality Assurance department. This team may include other relevant staff to identify the root cause of the complaint and to propose appropriate CAPA.
6.10.11 The members of the investigating team, shall carefully inspect details provided in the complaint form and record conclusions of the physical appearance of sample, seal etc., if the sample is available.
6.10.12 They shall also verify and compare details of references available in the document of the same batch number from the QA archives. The investigating team must review the retention sample and scrutinize the analytical report of the batch/ product under reference.
6.10.13 Destructive tests or chemical analysis shall be conducted, if required on the sample at this point of time.
6.10.14 The lead investigator in consultation with Head, Quality or designee shall arrange to carry out chemical and / or microbiological analysis of the retention sample (along with the complaint sample, if available) if deemed necessary based on the description of the complaint so as to establish the genuineness of the complaint.
6.10.15 The lead investigator shall then discuss results of the analysis with Head, Manufacturing or designee to extend the investigation at the production end.
6.10.16 Head, Manufacturing along with the respective department manager shall investigate the complaint in detail.
6.10.17 The investigation must include scrutiny of batch production records of the complaint batch for any manufacturing and / or packing problems encountered during its production, any equipment breakdowns recorded during production of the batch, and / or any material quality problems faced during manufacturing and packing of the batch.
6.10.18 Extend the investigation to similar complaints received earlier for the same product or other products.
6.10.19 Study and review the investigation reports of the earlier complaints of similar nature, and the stability data of the product, for any link to the cause of the received complaint.
6.10.20 At the end of investigation, Head Manufacturing shall communicate to the investigating team through verbal or written report, for further investigations.
6.11 In case of critical market complaints Head, Quality shall conduct an assessment in consultation with MD/ COO and will decide about the need to recall the product / batch as per the SOP for ‘Product Recall’ (SOP No.: QA007).
6.11.1 Market complaints of the following nature will be considered as critical.
=> Product mix up and label mix up.
=> Failure to meet regulatory specification (i.e. Assay, impurity).
=> Contamination due to foreign matter (e.g. Glass pieces, metal pieces, black particles, particulate matter, microbial growth etc.).
6.11.2 Notify the concerned market regulatory body in the event of any critical market complaint.
6.12 Manager, QA or designee shall record the detailed investigation and the response in the market complaint investigation form (Annexure-I).
6.13 Reporting and Response to Market Complaints
6.13.1 A final market complaint response report (Annexure-III) shall be prepared by Head Quality within 30 (thirty) working days of receipt of a complaint with samples, for products manufactured at site.
6.13.2 The market complaint investigation report must be exhaustive, reveal complete facts of investigation, identify the potential causes clearly in the best possible manner, must contain additional corrective action plans for preventing a recurrence of such complaints and also indicate actions already taken if any.
6.13.3 The report must conclude whether the complaint is substantiated or unsubstantiated. The complaint register must be completed with a brief report of the complaint investigation.
6.13.4 Head, Quality must sign off the complaint report and forward to complainant, if required. Copies of the report shall also be distributed to COO, Head of Marketing and Head of Manufacturing. For critical complaint the copy of the report shall be distributed to MD.
6.13.5 All records of complaints, reports, corrective and preventive actions taken to resolve the quality problems, responses to complainants, complaint register / log etc. shall be maintained by Manager QA or his designee.
6.13.6 Investigations for critical complaints must be completed within 3 (three) working days. (Microbiological report may not be included which take at least 5 (five) days to report). Investigations for major and minor complaint must be completed within 15 (fifteen) working days.
6.13.7 Detailed response report after a thorough investigation including complete analysis of control/retention sample (and/or complaint sample) shall be sent to the complainant.
6.13.8 Inform the concerned accordingly regarding the required time for analysis and a tentative date of secondary response, if the complaint is required to be confirmed with a microbiology analysis.
6.13.9 Complete the closure of all complaints along with its redressal within 30 (thirty) working days after the receipt of complaint. Any delays must be justified.
6.13.10 If no response is received from the complainant within 7 (seven) working days after sharing the investigation report, then the complaint shall be considered as closed and the closure status in the log register shall be updated as ‘Closed’ with sign and date.
6.13.11 In case of complaints received from marketing department, Marketing Manager shall attach his note to the response report from plant, and forward to the complainant. Copy of the same note shall also be sent to Head, Quality.
6.13.12 In case the complaint is received directly at site, Head Quality or Manager QA or their respective designees shall directly write to the complainant, copying the marketing department.
6.13.13 In case of complaint received for contracted products, manufactured by (Company Name) (contract acceptor) a communication to the contract giver shall be maintained and a copy of the investigation report shall be forwarded when the complaint is closed.
6.14 Complaint Redressal
6.14.1 Head of Marketing after consultation with COO shall appraise the customer on the corrective actions taken and on redressal actions, wherever necessary. A copy of such communication shall be forwarded to Head, Quality for reference.
6.15 Management Reviews of Complaints
6.15.1 The Market complaint report, trends, effectiveness of corrective actions etc. shall be summarized and reviewed in management review meeting.
