Procedure for handling of market complaints

1.0	PURPOSE To lay down a procedure for handling market/customer complaint.
2.0	SCOPE This procedure is applicable to all the market complaints received either directly or from any other sources.
3.0	RESPONSIBILITY Executive or above of concerned department and Quality Assurance.
4.0	ACCOUNTABILITY Head QA
5.0	PROCEDURE
5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9	Any communication, written or verbal, received directly from any Drug authority, customer, retailer, distributor or field staff, regarding the purity, efficiency, labeling defects or any other such complaint shall be considered as a market complaint. All such complaints shall be received at Company Name., channelised through as per complaint handling flow chart (Annexure I).  In case the complaint is routed through field staff, the sample shall preferably accompany the complaint. On receipt of the complaint, Executive/Sr. Officer Quality Assurance shall document the following details, in the customer complaint register.( Annexure II). a.      Sr.No. b.      Market complaint No c.       Complain Category d.      Complaint Received On e.       Name of the product: f.        Batch No. g.      Manufacturing Date h.      Expiry Date i.        Source of complain & Address j.        Nature of complain i.    Closing date All the market complaints shall be stored with the sequential number and logged as per the categories. Market Complaint proforma shall be numbered with 12 characters. The first two characters shall be MC (i.e. Market Complaint). Third character shall be slash. 4th &5th characters shall be representing the respective section (TB= For tablet, LI=Liquid, LO=Lotion, SO=Soap).  6thcharacter shall be slash. The Next three digits shall be sequence no. the sequence number starting from 001 to 999. 10th character shall be“/ “& 11th and 12 thcharacter shall be the year (financial ie. 12 for 2012) in which the market complain raised.  In case the complaint is regarding the product quality and efficacy, Quality Assurance Head shall carry out detailed investigations, check the control samples of the same batch and analyze the same. In case of adverse drug reaction, opinion of CQA/ DRA shall be taken. The goods returning from customers should be handled as per standard operating procedure for Handling of returned goods. QA Head shall review the complaints, categorize the complaint as mentioned below & then indicate the category number (by putting tick mark at appropriate place) in Annexure III. Market complaints shall be categorized as follows-
Defect		Category	Detail of complaint
Critical Defect		I	A def  A defect having a significant impact on product quality and / or safety and likely to have serious and / or harmful effect on the patient. Every  Reply to the complainant within 3 days from the receipt of complaint at the initiator, depending upon severity of the complaint.
Major Defect		II	A defect, other than a critical defect, that is likely to result in a failure or reduction in the suitability of use of a unit for its intended purpose. Reply to the complainant within 15 days from the receipt of complaint at the initiator.
Minor Defect		III	A defect that is not likely to reduce material feasibility of the unit of product for its intended purpose or as departure from established standards having little bearing on the effective use or operation of the unit. (e.g. Missing tablets / capsule, smudging of over printed matter, missing blisters, missing cartons, missing foils). Reply to the complainant within 30 days from the receipt of complaint at the initiator.
5.10 5.11 5.12 5.13 5.14 5.15 5.16 5.17 5.18	QA head shall investigate the complaint with the help of the Production Head or quality control Head as per Attachment - III. The Production Head shall check the production records and packing records during investigation and send a written investigation report to the QA Head. In case the complaint is regarding the product not being of standard quality, the QA Head shall carry out detailed investigation, e.g. check the control samples of the same The executed batch production & packing records shall be checked thoroughly by the QA Head to check for any deviations or abnormalities reported or recorded during the manufacturing of the said batch or whether extrapolated to other batches. QA Head shall complete the investigation by filling the details in the Market Complaint Investigation Report (Annexure III). QA Head shall send the final reply to the Functional Head of party with a copy marked to C.QA /Technical director & Director with suitably reply , corrective & preventive action. CAPA shall be raised after investigation by QA. QA Head shall compile all the complain related documents along with the reply letter and shall maintain a complaint file. The complaint shall be treated closed if; the complainant has raised no further query within 30 working days from the date of reply or if customer satisfied with response or corrective & preventive action suggested from complaint investigations has been implemented & their efficacy verified. The complaint file will be closed with necessary remarks on it and all the files should be archived at one place. If the conclusion of the investigation requires Product Recall, then the decision for the same shall be taken by the QA in consultation with CQA/ President Mfg. & Technical Director. The product shall be recalled as per SOP for Product Recall (XXX/SOP/QA/022). All the documents related to the market complaint shall be retained for at least one year beyond the expiration date of the product. Complaint record shall be reviewed annually for any indication of specific (or) recurring problems requiring      attention.
6.0	REFERENCES      SOP guideline by  D.H. Shah                                                                                                                                    cGMP Guideline

7.0

ANNEXURES

Annexure No.	Title of Annexure	Format No.
Annexure I	FLOW CHART OF MARKET COMPLIN	QA/021/F01-01
Annexure II	MARKET COMPLAIN LOG BOOK	QA/021/F02-03
Annexure III	MARKET COMPLAIN FORM	QA/021/F03-03

8.0	ABBREVIATIONS

Abbreviations						Full Forms
SOP						Standard Operating Procedure
QA						Quality Assurance
CAPA						Corrective and preventive action
CQA						Corporate Quality Assurance
9.0	DISTRIBUTION
Master Copy							Quality Assurance Department
Controlled office Copy No. 1							Quality Assurance Deptt.
10.0		REVISION HISTORY
S.No.			Revision No.	Effective Date	Reason for Revision			Details of Change	Authorized By (sign & Date)

                                                            Annexure I

Annexure II

MARKET COMPLAIN LOG BOOK

S.No.	Market Complain No.	Complain Rec. On	Complain Category	Product Name	Batch No	Mfg date	Exp.date	Complain Nature	Investigation Done By	Closing date

Annexure III

MARKET COMPLAIN FORM

Market complain No.			CATEGORY		I  /  II  /  III
Mention name of complainant & date of complaint
Initiated By	Mention name of initiator		(Initiator to sign here)
Name of the Product:
Batch No.		Mfg. Date		Expiry Date		Pack Size
Complaint Recd. From – Complainant (strike off whichever is not applicable)		Distributor / Field Staff / Stockiest / Doctors / Customer / Drug authorityOthers (please mention)
Nature of Complaint (strike off whichever is not applicable)		PACKING/PHYSICAL/ASSAY/CONTAMINATION
Immediate Action taken (if any) By whom & what
Complaint sample received		YES / NO  (ATTACHED / NOT ATTACHED)
In view of complaint all concerned are requested to investigate the case immediately and submit their finding  to Quality Assurance for further review and necessary actions.

Investigation done? If no, reason for not conducting the investigation.	YES / NO
Complaint discussed with (if required)	Production Head / QC Head / Others (Specify)
Batch Manufacturing / Packing Records; Reviewed	YES / NO
Any other document pertaining to GMP reviewed (if yes, Specify)	YES / NO
Control sample comparison Physical and / or Chemical parameters (Attach report on findings)
Review of analytical data	YES / NO
Whether complaint extrapolated to other batches
Findings (Attach separate sheet if necessary) Sign & department
Preventive & Corrective action suggested / taken(CAPA) (Attach separate sheet if necessary)
Signature & Date Head – Quality Assurance
Person responsible to conduct investigation and targeted date	Quality Control               : ______________________________ Production                      :  ______________________________ QA                              :  _____________________________
HANDLING STATUS	Investigation completed during ___________ to ____________ Date : ____________________          Manager QA