Market complaints SOP

Complaints show customer dissatisfaction about the quality of a pharmaceutical product. Despite a regulatory obligation in several countries, a good complaint handling system gives the company an opportunity to improve the quality of their products, being a good tool for the maintenance of Good Manufacturing Practices and a way to establish a committed relationship with their customers. A systematic procedure must be developed and implemented in order to register and investigate each complaint received and not only the Quality Assurance area must be involved. This process must involve other critical areas such as Marketing, Production, Quality
Control, Finance, Regulatory and Legal Affairs. Complaint handling is a Good Manufacturing Practice (GMP) requirement, since all complaints concerning potentially defective products must be carefully reviewed according to a written procedure

CLASSIFICATION OF MARKET COMPLAINTS

CRITICAL:

Product Mix-up.

Product not meeting regulatory specification.

Contamination & Microbial Growth.

Mix-up of printed packaging material.

Use of wrong printed packaging material.

Adverse drug reactions.

Regulatory notices advising recall.

Physical change in the product such as discoloration, precipitation.

MAJOR

Incidental contamination due to foreign matter including microbial growth.

Incidental mix-up related to printed packaging material limited only to few packs which can be called back from consignee.

Damage to packaging at the marketplace.

Wrong batch coding e.g. B. No., Mfg. Date, and Exp. Date etc.

Failing to meet statutory labeling requirement, content, generic name.

Smudge printing, empty pockets & tampering of shippers.

MINOR

Incidental failure of physical description or damages likely due to improper handling / storage.

Shortage e.g. less tablets in strips, less strips in cartons etc.

Excess e.g. more mono cartons in shrink wrap.

Deuteriation and / or damages due to improper storage/ shipping.

Failing to meet statutory labeling requirement (other than content and / or generic name)

Incidental occasion of printing or overprinting not legible.

Example of Complaint with Suggested Investigation

1.0 Ineffectiveness/ poor quality/ Inadequate response of the drug.

• History of the product.
• Physical inspection of complaint & control sample.
• Review of batch document for,
• Active RM ( Raw Material)calculation.
• added of active & inactive RM against bill of material.
• Source of material.
• Dispensing precautions: e.g. API dispensing & storage in the black/ light resistant bag or container.
• Processing precautions: e.g. dissolved oxygen, safe light and nitrogen flushing or any other.
• Dose control record.
• Processing parameters.
• In-process checks by production & QA.
• Daily quality observation record.
• Any deviation, which has direct or indirect impact on product quality.
• In process quality control data.
• Review of FP analytical report & trend.
• Review of stability data.
• Complaint & control sample analysis for (as applicable),
• Volume variation.
• Content uniformity.
• Degradation
• Related Substance.
• Moisture content.
• Biological assay, where required.
• Storage condition.
• Audit of C & F agent or retailer if required.

2.0 Less content in capsules/ tablet/ vial/ ampoule/bottle.

• Physical inspection of complaint & control sample,
• For minor crack.
• Improper sealing.
• Condition of container label & / or show box to eliminate Possibility of leakage.
• Review of batch mfg. record for, Active RM calculation.
• added of active & inactive RM against bill of material.
• In process checks by production & QA.
• Visual inspection record.
• Leak test record.
• Yield & reconciliation of the batch.
• In-process & FP quality control data.
• Trend of yield.
• Sequential log of filling or compression or capsule filing machine

For breakdown or any other problem observed during processing .

• Daily quality observation record.
• Complaint & control sample analysis for as applicable,
• Content uniformity.
• Related Substance
• Volume variation.

3.0 Bulging of strip pockets.

• History of the product.
• Physical inspection of control & complaint sample.
• Improper storage condition.
• Review of stability data.
• Analysis of complaint &/or control sample for as applicable,
• Related substance.
• Moisture content

4.0 Presence of foreign matter (Living / non living).

• History of the product.
• Physical inspection of complaint & control sample for,
• Minor crack.
• Improper sealing.
• Daily quality observation record.
• pH trend.
• Physical inspection of particular AR No. used for mfg. of the
• Review of batch mfg. record for,
• Primary Packing Material
• Use of pretreated ampoules (e.g. acid treated amps).
• Empty primary Pkg. material washing & sterilization in record.
• Cleaning record of mfg., filtration & filling equipment’s & area.
• Sterilization record of filtration & filling equipment’s.
• Filter integrity test results (Pre & post filtration).
• Leak test record.
• Terminal sterilization record.
• Sequential log of washing machine.
• Environmental monitoring data.
• Quality/compatibility of closure and primary packing material.
• Analysis of complaint sample/ control sample for,
• Identification of preservative.
• Content of preservative.
• Related substance
• Microbiological analysis of complaint sample/control sample.
• Training record of visual inspectors.

5.0 Adverse event /  Adverse drug reactions  (e.g. vomiting, severe cramps/Rashes)

• History of the product.
• Microbiological analysis of complaint sample/control sample.
• Pharmacology of the API & related formulations.

6.0 Discoloration of solution or tab/ liquid.

• History of the product.
• Physical inspection of complaint & control sample for,
• Minor crack.
• Improper sealing.
• Review of batch mfg. record for,
• Special precautions required during processing e.g. dissolved oxygen, low light, nitrogen flushing or any other.
• Cleaning record of mfg., filtration & filling equipments & area.
• Leak test record.
• Daily quality observation record.
• Recovery procedure.
• In-process checks by production & QA during mfg. & packing.
• Analysis of control &/or complaint sample for as applicable,
• Related substance
• Stability data.
• Storage condition.

7.0 Damaged/broken/ leaking bottles.

• Physical inspection of complaint & control sample.
• Review of batch mfg. record for,
• Visual inspection record & humidity conditions.
• Filling machine setting parameters.
• In process checks during mfg. & packing by QA & production.
• Vendor of empty bottles
• Sequential log of filling machine for breakdown.
• Training of the visual checkers.

8.0 Broken tablets

• History of the product.
• Physical inspection of complaint & control sample.
• Review of batch mfg. record for,
• In process checks by production & QA during mfg. & packing.
• Visual inspection record.
• NFD checking of cracking
• Review of trend of processing, in process & FP parameters.
• Daily quality observation record.
• Handling of the bulk product and hold time.
• Training record of the visual checkers & strip packing machine operator.
• Analysis of control &/or complaint sample for, Friability ,Hardness
• Monitoring of de-foiling & repacking activity.

9.0 Product or batch mix-up.

• Physical inspection of control & complaint sample for physical Appearance of primary pkg. material of two products under question.
• System followed to ensure proper segregation product at different  Sequential log of machine at every stage to know the previous or next product taken on the same machine & to ensure absence of same /similar product in the surrounding area.
• Other products packed on the same day on the nearby labeling machine or packing line of product under question.
• Review of batch mfg. record for, Machine & line clearance record at different stages.
• Reconciliation of packaging materials.
• Reconciliation of bulk & FP.
• Analysis of control &/or complaint sample for Identification test of two products under question.
• Identification test of preservative.
• Wrong labeling/ packing.
• Daily quality observation record.
• Monitoring of de-foiling & repacking activity.
• Training record of packers.
• Repacking if done at any C& F location.

10.0 Fake product.

• History of the product.
• Comparison of complaint sample with control sample for appearance of strip/ label (font size of letters, printed text matter, size of the pocket, gap between the two pockets, knurling pattern, logo of the company, movement of tab or cap in the pocket etc).
• Comparison of complaint sample with control sample for appearance of tablet or capsule (size or dimensions, color, imprint, embossing, edge type etc).
• Comparison of primary packaging material (Vial/ ampoule/strip/blister/bottle) for shape & size, sealing, height, type of seal, logo on the seal, color of the seal, type of rubber stopper etc.
• Analysis of complaint & / or control sample.

11.0 Empty primary container (bottle / pocket of strip or blister)

• Physical inspection of control &/or complaint sample.
• Sequential log of filling or striping or blistering machine for breakdown or any other problem.
• Review of batch document for, In process checks by production & QA during filling.
• Leak test record.
• NFD challenge & working.
• Visual inspection record.
• In process checks by production & QA during packing (e.g. on line compressed air flow or any other system followed to remove empty plastic container or empty pocket in strip or blister).
• Yield & reconciliation of the batch & comparison with trend.
• Balance performance & calibration check record.
• Weight variation record of packed show boxes & / or shippers.
• Proper segregation of packed & empty boxes.
• Daily quality observation report.
• Training record of the visual inspectors.
• Vendor of primary container (as cause of empty container may be hair line cracks due to weak MOC of container).

12.0 Receipt of product in different show box/ having different label.

• Complaint sample observation.
• Physical inspection of control sample.
• Previous & next product packed on the same machine.
• Appearance of packing material of two products under question.
• Review of batch document for,
• Line clearance (by packing & QA) record.
• Reconciliation of packing material.
• Machine & line clearance record.
• In process checks by packing & QA.
• Product packed on adjacent lines/nearby area.
• Daily quality observation record.
• Storage of packing material in the store & in pkg. Dept.
• Procedure to be followed for the left over pkg. Material after completion of packing.
• Monitoring of delabeling & relabeling/ repacking activity.
• Inspection of reaming stock of PM of the products under question.PM vendor audit.
• Training of packers.
• Repacking if done at any C& F location/depot.

OBJECTIVE :

To establish a procedure to investigate, document, respond and review of  all product-related complaints received. Complaints can be about packaging material, such as ‘the bottle is leaking’, ‘the cap is difficult to open’, ‘the label color is fading’, ‘one tablet in the blister is missing’ or concerning the product’s aspect and effect, such
as ‘there is no effect’, ‘the tablet or solution color is different’, ‘the tablet is broken’ and so on. Whatever it is about, a complaint shows customer dissatisfaction about a product and, consequently, about a company.

RESPONSIBILITY :

Quality Assurance department to process and respond to all product complaints.

Head – RA to co-ordinate with concerned Regulatory Authority.

Head of Quality Assurance Department to ensure compliance.

PROCEDURE

Every  product  complaint  received  shall be appropriately documented and responded to in a responsible manner.

All the departments shall be instructed to forward all written and oral product complaints to the Head of Quality Assurance Department.

Each complaint will be assigned a five-digit complaint number consisting of the last  two  numbers  of  the current year, followed by a dash and the next sequential three digit number.

For e.g.., The first complaint received in 2023 will be assigned complaint number 23-001.

Note : If a product complaint is determined to be serious and unexpected as stated  in  21 CFR 314.80(c)(1)(i),

The  Complaint  Information  Form (annexure-1)  shall  be  filled   in   order  to document all the available information regarding the complaint by Officer-QA and filed in Complaint File kept in QA Office.

If any complaint sample is received, the same shall be labeled with the complaint number.

A  complaint acknowledgment letter shall be sent to the complainant in a timely manner. A  copy  of  the  acknowledgment  letter will be filed in the complaint file.

If  the  complaint can be attended within one week, the final response letter can be submitted to the complainant instead of the complaint acknowledgement letter.

All the final responses, shall be sent within 15 days from the date of receipt of complaint or upon full information on the complaint.

PHENYLPROPANOLAMINE TABLET AND IT USES

Investigation :

Head – Quality Assurance shall arrange for review of Batch Production Record, as necessary.

Head – Quality Assurance shall arrange for examination of Reserve Sample of the complaint batch, as necessary.

An investigation request memo along with any available product sample, shall be  forwarded  to  the concerned department by the Head of Quality Assurance department  for investigation.

The appropriate department investigating the complaint shall document their findings and conclusions and prepare a report.

In case an investigation is not desired, the reason and name of the responsible person taking this decision shall be stated on the report.

The report along with any remaining complaint sample, shall be forwarded to the Quality Assurance department.

Officer – QA shall ensure storage of remaining complaint sample in reserve sample room.

Depending upon the nature of the complaint, extend the investigation to other related batches also.

Once the investigation is complete, Head of Quality Assurance department shall review the report and correlate with trend analysis data available for the concerned product as per SOP “Annual Review of Drug Product Quality”.

Head  of  Quality  Assurance  department  shall  prepare  the   final response letter to the complainant or the appropriate agency. A copy of the same shall be distributed to Divisional Head and  Head of  RA department and  a  copy shall  be  filed  in Complaint File.

All forms, documents and correspondence associated with the complaint shall be identified with the complaint number and filed in the complaint file.

Each  written  complaint  shall  be  maintained for at least one year after the expiry  date  of  the  drug  product or one  year  after  the  date on which the complaint was received, whichever is longer.

In  case  of  certain drug products lacking expiration dating, the written complaints shall be maintained for 3 years after distribution of the last lot of drug product or 1 year after the date on which the complaint was received, whichever is longer.

A  trimonthly  status  report  of  complaints  shall  be  generated by Head of Quality Assurance department and forwarded to Management review committee comprising of Division Head and all departmental heads for a detailed review.

The status report of complaints shall be filed in the complaint file.

If the same batch of a product is distributed in more than one country and complaint is received from a country, then the status of the product in other countries shall also be investigated depending upon the nature of the complaint and the Regulatory Authority / (s) of the country / (s) shall be informed.

Product complaints SOP

Annexure 1.

Specimen format of “Complaint Information Form” – 

COMPLAINT INFORMATION FORM

• Complaint No/Date
• Product name & Strength/Batch/Lot No./Batch/Lot Size
• Expiry Date/Manufactured by & At
• Complainant’s Name /Company/Complainant’s Address
• Complainant’s Phone No./Complaint  Received Via MAIL/PHONE/FAX/OTHERS
• Sample available: Yes / No
• Sample received on/Amount of samples sent
• Nature of Complaint Signature /Date
• The final response to the complainant given on

Product complaints SOP