1.1 To lay down a standard procedure for Handling, Investigation, and Reporting of Market complaints.
2.0 SCOPE
2.1 This SOP shall be applicable for the handling of market complaints received from the sponsor/customer in the Department of Quality Assurance (QAD).
3.0 RESPONSIBILITY
3.1 Head- QA
3.2 QA Personnel (QAP)
4.0 DEFINITIONS
4.1 Normally complaints are of the following nature :
4.2 Delay in reporting
4.3 Wrong Study Procedure
4.4 Inadequate specification
4.5 Faulty result
4.6 Error in billing etc.
5.0 PROCEDURE
5.1 The aim of the investigation of the market complaint should be :
5.1.1 To identify the problem
5.1.2 To ascertain the probable cause of the problem
5.1.3 To suggest corrective/preventive actions
5.2 Check and investigate for the specific complaint received. All the relevant documents should be reviewed.
5.3 Receipt of Complaint
5.3.1 When a complaint is received it shall be forwarded to QA Head.
5.3.2 QA Head or designee shall log in the complaint in the Complaint Log as per ‘Market Complaint Record’ in Format No.:-F………………. and allocate the complaint number.
5.4 Numbering of Complaints
5.4.1 All complaints shall be numbered as per a unique numbering system of 14 characters as below:
CMP/XXX/YY/ZZZ
5.4.2 For example The 1st complaint of the year 2021 of the AHF department shall be numbered as CMP/AHF/21/001
5.5 Type of complaints
5.5.1 For delay in reporting
5.5.1.1 Check the entry of the sample received in the sample inward register
5.5.1.2 Check the entry of completion of the analysis
5.5.1.3 Check the date of dispatch of the reports
5.5.1.4 Determine whether the delay was due to analysis delay, or other reasons.
5.5.2 For test procedure/specification:
5.5.2.1 Check study procedure/ specification received from party.
5.5.2.2 Check procedure/ specification followed by the chemist
5.5.2.3 Compare the procedure/ specification with the standard procedure described in the Pharmacopeias or reference book.
5.5.3 For faulty result:
5.5.3.1 Check the details of the report, as to the test item, date of the study, procedure, instrument, reagents, and analyst from the documentation.
5.5.3.2 Check the validation and calibration record of the instrument/ reagent.
5.5.3.3 If no fault could be detected by the review of documents proceed for cross-examination of the results by re-study from retained test item sample.
5.5.3.4 If the repeat study analysis results vary significantly from the said report, investigate the case thoroughly and submit a report to the QA head.
5.5.4 Error in billing
5.5.4.1 Check the details of billing with the accounts department and make necessary correction/s if any mistake is observed.
5.6 The time frame for the closure of the complaint
5.6.1 The investigation finding must be communicated to the customer within 30 working days.
5.6.2 Once the complaint is logged in the market complaint log, QA-authorized personnel will review the data and shall summarize their findings in Format No. F…………. after discussing with the Head of the other respective department and sending the revised report to the customer.
5.6.3 In case no feedback is received from the customer, within four weeks the complaint will be treated as closed unless the customer opens the complaint again.
5.6.4 The QA department should implement the procedure in a way to avoid the reoccurrence of such defects in the future if the complaint is substantiated.
6.0 ENCLOSURES
6.1 Formats
7.0 ABBREVIATIONS
7.1 SOP- Standard Operating Procedure
7.2 QAD- Department of Quality Assurance
7.3 AHF- Animal House Facility
8.0 REFERENCES
8.1 In-house
5.4.1 All complaints shall be numbered as per a unique numbering system of 14 characters as below:
CMP/XXX/YY/ZZZ
Where, 1st, 2nd and 3rd characters are ‘CMP’ signify Complaint; 5th, 6th and 7th Characters are ‘XXX’ which signify ‘Department Code’ to which Complaint belongs i.e. QAD for Quality Assurance Department, AHF for animal house Facility 9th and 10th Characters are ‘YY’ signify the last digit of the year in which complaint received; 12th, 13th and 14th Characters are ‘ZZZ’ which signify the serial number of Complaint. eg. 001, 002, etc.; Character no. 4th, 8th, and 11th are oblique Mark (/).
5.5 Type of complaints
5.5.1 For delay in reporting
5.5.1.1 Check the entry of the sample received in the sample inward register
5.5.1.2 Check the entry of completion of the analysis
5.5.1.3 Check the date of dispatch of the reports
5.5.1.4 Determine whether the delay was due to analysis delay, or other reasons.
5.5.2 For test procedure/specification:
5.5.2.1 Check study procedure/ specification received from party.
5.5.2.2 Check procedure/ specification followed by the chemist
5.5.2.3 Compare the procedure/ specification with the standard procedure described in the Pharmacopeias or reference book.
5.5.3 For faulty result:
5.5.3.1 Check the details of the report, as to the test item, date of the study, procedure, instrument, reagents, and analyst from the documentation.
5.5.3.2 Check the validation and calibration record of the instrument/ reagent.
5.5.3.3 If no fault could be detected by the review of documents proceed for cross-examination of the results by re-study from retained test item sample.
5.5.3.4 If the repeat study analysis results vary significantly from the said report, investigate the case thoroughly and submit a report to the QA head.
5.5.4 Error in billing
5.5.4.1 Check the details of billing with the accounts department and make necessary correction/s if any mistake is observed.
5.6 The time frame for the closure of the complaint
5.6.1 The investigation finding must be communicated to the customer within 30 working days.
5.6.2 Once the complaint is logged in the market complaint log, QA-authorized personnel will review the data and shall summarize their findings in Format No. F…………. after discussing with the Head of the other respective department and sending the revised report to the customer.
5.6.3 In case no feedback is received from the customer, within four weeks the complaint will be treated as closed unless the customer opens the complaint again.
5.6.4 The QA department should implement the procedure in a way to avoid the reoccurrence of such defects in the future if the complaint is substantiated.
6.0 ENCLOSURES
6.1 Formats
|
Sr. No. |
Format Title |
Format No. |
No. of pages |
|
1. |
Market Complaints Record |
F………………. |
01 |
|
2. |
Market Complaints Investigation Report |
F………………. |
01 |
7.0 ABBREVIATIONS
7.1 SOP- Standard Operating Procedure
7.2 QAD- Department of Quality Assurance
7.3 AHF- Animal House Facility
8.0 REFERENCES
8.1 In-house
9.0 REVISION HISTORY
9.1 Nil
END OF THE DOCUMENT
9.1 Nil
END OF THE DOCUMENT
You may like to read these links:
Hi. I’m Writer of Researchsop.com. ’ ’ Please share these SOPs to all concern pharma people for their development. I like to fullfill the need of curious people. These things inspire me to make things looks better.
0 comments:
Post a Comment