How to handle Market complaints

Market complaint: Any written or verbal communication, received from any customer, Govt. Agency, pharmacy, retailer, distributor, regarding the purity, safety, strength, efficacy packaging, labeling, shortage or any other issue which claims to be related to the quality of the product in the opinion of the complainer, shall be considered as market complaint.

1. A complaint may be received by site,director, marketing, distribution, contract giver or regulatory agency. If the complaint is received by other function, the communication regarding the complaint shall be forwarded to Quality unit for investigation.
2. Head of quality unit shall be responsible for handling of the complaint and the details shall be recorded in the “Market Complaint Register”. He/she shall be assisted by a technical team from Quality Assurance, Utility, Production, Quality Control and Medical department depending on the nature of the complaint. 
3. Market complaints shall be assign an unique number with full details of product information and nature of complaints like packaging defect,product quality or adverse drug reaction etc.
4. After receiving the complaint an impact assessment shall be performed by quality unit on the basis of  impact assessment the complaint shall be categorized as critical, major and minor. In case of critical complaint perceived or known (serious health hazard), the decision shall be taken for “Product Recall” by Quality unit.

• Critical: Involves a health hazard situation where there is a reasonable probability that use of product will cause serious adverse health consequences or death, or complaints which have a direct and immediate impact on the product quality, safety, purity, efficacy, and which impact patient health and safety and patient compliance , Loss of potency, failure to meet the Microbiological specifications, etc; shall be classified as Critical complaints.
• Major: Involves a potential health situation where there is a remote probability of adverse health consequences from the use of the product. Or Insufficient batch coding details, inadequate product details shall be classified as Major.
• Minor: Involves a situation where the use of product is not likely to cause adverse health consequences, Or Shortages of products in specified packs shall be classified as Minor complaints.

Quality unit shall acknowledge the receipt of the complaint directly through writing to the complainant as per following...

➝For critical: Immediate,
➝For Major & Minor  within three working days.

1. Quality unit with cross functional team , investigation shall be initiated  through follow of investigation of pharmaceuticals product procedure. 
2. Complaint sample shall be checked for counterfeiting. In case found counterfeit, information shall be sent to the legal department / marketing department or respective regulatory agency. complaint sample shall be thoroughly examined for integrity of pack, physical appearance, any signs of tampering, etc. 
3. Depending on the severity of the complaint, investigation shall be carried out through checking of product records, quality control analytical records, distribution records, material sources, deviation in batch process, if any in consultation with the related departments.The batch history shall also be checked for any reporting of similar complaints in the batch with details and reference number, if applicable.
4. If a product quality defect is identified or suspected in the complaint batch, previous and succeeding batches shall be checked to determine whether they are also affected. Where the active pharmaceutical ingredient of the same batch or lot has been used in other batches of the product, batches having the active ingredient may be required to be tested based on recommendation of investigating team. The investigation team shall submit the investigation report to Head of Quality unit.During assessment of complaints if it is suspected that the other products/batches may also be impacted, investigation shall be extended to cover these products or batches. 
5. In case the complaint batch fails to meet the predetermined approved specifications, it must be recalled from the market as per Product Recall procedure.
6. The “Customer Complaint Investigation Report” shall be completed along with all observations and recommendations within 30 days of receipt of complaint at the site. However, based on specific nature if the more time is required, the same shall be communicated to the complainant. Some of the complaint may be replied to the complainant immediately depending on their nature. The investigation report shall be shared with the complainant/ Director/ marketing/ distribution or the contract giver, as applicable.

Complaint Closer: In case no further query is received within 30 days of response to complainant, the complaint shall be closed. or In case, the complainant raises further queries, the investigation shall be continued till it is closed.

In case, require information are not provided by the complainant within 30 days from the date of receipt of the complaint, the complaint shall be treated as closed with necessary intimation to the complainant.