Solitaire Pharmacia Pvt. Ltd

SOLITAIRE PHARMACIA PVT. LTD.

Objective

To define the procedure for investigation and reporting of marketing complaints & returns.

Scope

This procedure is applicable to investigation of Market complaint & return /Query arising from distributed finished product manufactured at Solitaire Pharmacia Pvt. Ltd., Baddi.

Responsibility

Manager – QA for receipt, logging and follow up for closure

Manager-Production for providing support in identifying the root cause and implementing the CAPA

Manager-QC for providing support in identifying the root cause and implementing the CAPA

Accountability

Sr. Head QA

Procedure

Market Complaint

Market Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a finished product after it is released for distribution.

5.1 Complaint Information

5.1.1 Market complaint received from the customer shall be acknowledged to marketing department, assuring immediate attention.

5.1.2 Any verbal or written communication received directly from any Regulatory authority, customer, retailer, distributor or field staff, regarding the purity, efficacy, side effect, labeling / packaging defects, shortages or any other such Complaints shall be considered as a Market Complaints.

5.1.3 All market complaints shall be received either directly from the customer or through Marketing by Head- Quality Assurance. It shall be forwarded to concerned department heads through an internal communication (Verbally or through e mail).

5.1.4 Initial acknowledgement shall be given to customer immediately after receipt of the complaint.

5.2 Complaint Registration

5.2.1 The complaint shall be registered in Complaint Record as per current version of Format No. SPL/QA/065.

5.2.2 Quality Assurance shall assign a Control No. to each complaint as

CR/XX/YY/ZZZ

Where

CR - Complaint Record

XX - Last two digits of the year

YY - Month

ZZZ - Serial number in continuation over the year.

e.g. CR/07/01/001 (for each year; ZZZ shall start from 001)

5.3 Complaint Categorization

Market Complaints will be categorized as

5.3.1 Demand and Supply complaints.

5.3.1.1 Any complaint that is related to problems with Logistics for example wrong packaging or labelling, wrong product delivered, wrong quantity, arrival time, packaging damage, any other problems related to transportation.

5.3.1.2 Sales Order (Administrative / Financial and related documentation, delivery, shipping, billing, invoice, payment method, demand forecasting or supply and inventory planning.

5.3.1.3 Physical damage to containers

5.3.1.4 Short supply

5.3.1.5 Poor presentation of product containers

5.3.1.6 Commercial complaints

5.3.2 Technical complaints

5.3.2.1 Product performance related complaint: Any complaint that results from poor performance of the manufactured product.

5.3.2.2 Product performance related complaint: Any complaint that results from poor performance of the manufactured product.

5.3.2.3 Physical/chemical attribute of the product

5.3.2.4 Out of specification test results

5.3.2.5 Complaints related to stability

5.3.2.6 Un coded or wrongly coded product/ Batch No

5.3.2.7 Incorrect manufacturing date/ expiry date

5.3.2.8 Product Technical Complaints (PTC)

5.3.2.9 Extraneous matter

5.3.2.10 Particle size/sieve analysis

5.3.2.11 Returns Product Packaging

5.3.2.12 Poor Performance in Customer's Use

5.4 Complaint Investigation

5.4.1 Each complaint shall be thoroughly investigated as per current version of Format No. SPL/QA/066.

5.4.2 Minor packaging defects shall be communicated to production and investigation shall be carried out by reviewing packing list, blending batch sheet and sifting batch sheets.

5.4.3 All quality (analytical) related complaints shall be referred to Head-QC along with investigation format as per current version of Format No. SPL/QA/066.

5.4.4 If complaint is related to quality parameter then control sample shall be analyzed for that specific test by the analyst other than the one who had initially performed the test.

5.4.5 Manager-QA may seek additional information from the customer vis-a-vis methods, sample handling, storage etc. through the Marketing manager.

5.4.6 On receipt of quality related complaint, Manager-QA shall examine the retention sample of the batch corresponding to the complaint.

5.4.7 If the complaint sample is received, he shall compare the retention sample analysis with that of complaint sample and evaluate the differences observed, if any.

5.4.8 If the data indicates variance with initial COA value - (such as, drop in Assay or rise in Impurities below limits), Manager-QA shall proceed with the investigation.

5.4.9 If the results are same as in certificate of analysis (in case of quality related complaints or in case of minor packaging defects), marketing manager shall be informed accordingly.

5.4.10 If the analysis reveals any stability related problems, Manager-QA may investigate batch history, storage and distribution. If no abnormality is found, he shall seek help from R&D for additional inputs.

5.4.11 Manager-QA shall share the findings with the Production Head and Head-QA along with inputs from R&D, as applicable.

5.4.12 Manager-QA and Production Head shall review various records/ documents during investigation. These may include executed BPRs, analytical records, sampling and release records and other processing records.

5.4.13 The Manager-QA shall summarize his findings after discussing with the plant head.

5.4.14 The manager QA shall decide if other batches or customers could have been affected for justified complaints and decide on actions to be taken

5.4.15 Manager-QA shall complete the market complaint investigation within 30 business days, In case there is a need to extend the Investigation beyond 30 days, interim report shall be made by Manager-QA. The reason for delay in investigation will be mentioned in the interim report. Thereafter subsequent monthly review shall be done by Manager-QA. Manager-QA shall communicate the summary of findings to the marketing.

5.4.16 Manager-QA will decide in liaison with customer if complaint is justified, not justified or cannot be verified.

5.4.17 A CAPA will be opened for each justified complaint. Timely closure of CAPA’s from each complaint will be monitored by QA and actions taken if original timelines are not met

5.4.18 A copy of the report shall be sent to Plant Head, Head-QA.

5.5. Complaint follow-up

5.5.1 Complaint Investigation results shall be communicated to the customer directly or through marketing. In case of direct communication with customer, a copy of communication shall be forwarded to marketing.

5.5.2 Quality Assurance Head may seek additional information from the customer vis-à-vis methods, sample handling, storage etc.

5.6. Complaint closure

5.6.1 The QA Manager/ Head or designated person, based on compiled investigations and data, shall initiate the corrective action and final decision.

5.6.2 A copy of communication or formal written response shall be forwarded to marketing department customer and closure action shall be recorded in Complaint Record.

5.6.3 The complaint shall be considered as open for 30 days after the reply to the customer. If no further query or feedback is received from the customer during this period the customer shall be assumed to be satisfied and the complaint shall be considered as closed. The same to be communicated to customer.

5.6.4 For Quality Critical complaints, Quality Assurance Head shall ensure that customers and regulatory authorities are informed within 3 working days if there is need for product recall from market and further activity shall be governed by Current Version of SOP/QA/028 “Product Recall”

5.6.5 Head Quality Assurance shall ensure that all complaints are taken to their logical conclusion. He shall monitor the corrective actions taken and ensure the closure of complaints.

5.6.6 Corrective and Preventive Actions shall be initiated to prevent the acts, which might have caused the problem.

5.6.7 Any non compliance of the batch to be extended to the other batches or product if necessary.

5.7. Handling of Market Returns Materials.

Material can be returned from the market due to following reasons but not limited
to these reasons.

Based on the market complaints
Due to any commercial reason

5.7.1. In case of complaint having been justified, Head-QA shall recommend for action viz.
Material return, replacement or compensation.

5.7.2 Marketing department shall inform about returned material both to Commercial and QA department through the fastest means of communication.

5.7.3. After receipt of returned product, commercial department shall intimate excise authorities for verification and permission to transfer material in segregated area allocated for storage of recalled products shall be stored under lock & key.

5.7.4 Commercial department shall do reconciliation between the delivered and the received quantities of the product and shall inform to Quality Assurance for transfer of returned material as per Format No. SPL/QA/067.QA shall register return material in Return material Record as per current version of Format No. SPL/QA/070 and shall do the verification of returned material as per current version of format no.SPL/QA/068.

5.7.5 Quality Assurance shall assign a Control No. to each Market return as

MR/XX/YY/ZZZ

Where

MR - Material return

XX - Last two digits of the year

YY - Month

ZZZ - Serial number in continuation over the year.

e.g. MR/10/01/001 (for each year ; ZZZ shall start from 001)

5.7.6 The QA Manager on receipt of returned material shall inspected the material and put a label “HOLD”

5.7.7 Quality assurance shall perform the sampling as per current version and ask to quality control for analysis of

- Returned material

- Control sample (if required)

5.7.8 On the basis of verification and investigation by the Quality assurance as per current version of Format No. SPL/QA/068. QAM shall take decision regarding disposal of returned product.

5.7.9 If the decision is to destroy the material it shall be done with prior approval of excise department and Head-QA and shall be recorded as current version of Format No.SPL/QA/069.

5.7.10.Sample of returned material shall be preserved in the control sample room till the closure of the complaint.

Note: If the material is return from the market due to commercial issue & during QA verification material is received in intact packing verified against record then material can be diverted to other customer based on QA recommendation (for repacking if applicable) and shall be recorded in the market return record logbook

5.8. Preservation of Records

All the relevant correspondence made with customer along with investigation report and associated documents shall be compiled and shall be archived and stored for a period of 7 Years from the date of receipt of complaint.

Records/Formats

SPL/QA/065 -Complaint Record

SPL/QA/066 -Complaint Investigation

SPL/QA/067 - Returned Material Transfer Note

SPL/QA/068 - Verification of Returned Material

SPL/QA/069 - Approval for Destruction of Returned Material

SPL/QA/070 - Market Return Record

7.Annexure

Reference

ICH Q7

9.Abbreviations

SOP -Standard Operating Procedure

SPL -Solitaire Pharmacia Pvt. Ltd., Baddi

QA -Quality Assurance

ICH -International Conference on Harmonization

COA - Certificate of analysis

MDA No. - Material Dispatch advice no

QAM -Quality Assurance Manager

QC -Quality Control

CAPA - Corrective and preventive action

BSR - Bounded storage room

R&D - Research and development

Revision History

Revision No. / Effective Date / Reason for Revision
01 / New Document

Format No.SPL/QA/001

SOLITAIRE PHARMACIA PVT. LTD.

Market Complaint Record Logbook

Format No: SPL/QA/065

Date / Complaint no. given by Q.A. / Product Name / Name of Customer / Batch No. / Brief Description / CAPA No. / Status of closure of complaint

Complaint Investigation

Format No. SPL/QA/066

1. COMPLAINT LOG

Product:
Complaint No.: / Date:
Complaint received from customer/ marketing:
Type of Complaint Technical Demand And Supply
Batch No.: / Mfg Date: / Exp./Retest Date :
Complaint Qty.:

Description of complaint

Complaint Login by:

2. DISPATCH DETAIL

Dispatched on :

Dispatch qty :

No. of containers dispatched :

Reconciliation detail

Total Manufactured qty. :

Other batches dispatched to customer :

Other customer of same batches :

3 .INVESTIGATION REPORT Date:

Investigation shall be carried out in the given below areas but not limited to

A. Analytical Investigation

Check the analytical record of finished product & other materials used in the manufacturing :

Check availability of customer specification /test method

Check analytical trend of finished product w.r.t. to specification /test method:

Check the stability data trend :

Check the OOS if any :

Check the qualification of Instruments:

Check Working standard and reference standard record

B. Manufacturing Investigation

Check the complete manufacturing records :

Check trend of the batches :

Check deviation if any :

Check the reconciliation record of all materials used in the manufacturing :

Check the qualification of equipment :

Check the material is used for manufacturing from approved vendor :

C. Post Analysis

Retention Sample/Complaint Sample Analysis:

D.Conclusion:-

Investigation Summary Report

Intimation sent to customer on

Manager– Q.A.

(Sign /date)

CLOSURE OF COMPLAINT:

Final response from customer

Final status of the batches

Manager– QA Head – Q.A. Head- Production

(Sign /date) (Sign /date) (Sign /date)

Returned Material Transfer Note

Format No. SPL/QA/067

From:Commercial Department

To:Quality Assurance Date:

We are transferring following returned material to BSR.

S No. / Product / Batch No. / Customer Name / Quantity
Dispatched / Quantity
Returned / Reason for Returns

Remarks:

Sign/Date

Head-Commercial

Market Return Record

Format No: SPL/QA/068

S.No. / Date / Control no. given by Q.A. / Product Name / Name of Customer / Batch No. / Market complaint reference /other reason / Sign / Fate of the batch / Sign

Verification of Returned Material

Format No. SPL/QA/069

Product :

Batch No :

Mfg. Date :

Exp. /Retest Date:

Reason for return :

Date of return of Material :

Verification report of return:

Verification shall perform in the given below areas but not limited to:

Check the intactness of packing:

Verify by

Fate of the batch : To be reprocessed /diverted /destroyed

Remarks :

Head-QA Head production

Date: Date:

Approval for Destruction of Returned Material

Format No. SPL/QA/070

Product :

Batch No. :

Lot No. :

Quantity :

Mode of destruction:

Date of destruction:

Approval Given By / Destructed by
Sign/Date
Excise Department / Sign/Date
Head production
Sign/Date
Head-QA
Name :
Sign/Date :
Checked By:
Name :
Sign/Date :

Format No.SPL/QA/001