Complaints: Complaints and evaluation of complaints, Handling of return goods, recalling and waste disposal.

1. Complaints
SUBJECT: Pharmaceutical quality assurance
SUBJECT INCHARGE: Ms. Ashwini u. Bhoir
Assistant professor
in pharmaceutics

2. A ‘Complaint’ simply designates, that something is wrong or not good enough.
Generally, in the pharmaceutical industry, complaints are regarding the quality of
drug product.
A complaint shows customer dissatisfaction about a product and consequently,
about a company.
Introduction
Principle
All complaints and other information concerning potentially defective products
should be carefully reviewed according to written procedures and the corrective
action should be taken.
Objective
To immediately recall, investigate or to take remedial measures against
the defective product.

3. NEED FOR COMPLAINT HANDLING SYSYTEM
• It gives the company an opportunity to improve the quality of the
product.
• It is helpful to maintain cGMP.
• It maintains committed relationship between the customer and company.
• It is the regulatory obligations.
Quality Complaints: originate at consumer level and concern with
physical, chemical and biological properties or condition of labeling
and/or packaging of the product.
Adverse reaction Complaints: Due to allergic reactions of any other
untoward reaction or fatal reaction or near fatal reaction.
TYPES OF COMPLAINTS

4. Other medically related Complaints:
Include Complaints such as lack of efficacy or clinical response.
Time period for investigation after receipt of complaints:
1. Product quality complaints- within 10 days
2. Adverse reaction complaints- within 5 days
3. Medical complaint- within 3 days
• Complaint records shall be maintained at least one year after
expiration date of medicines. Complaint records shall be reviewed and
a monthly summary shall be prepared for the management.
• Also the complaints are categorized as following ✓ CRITICAL
DEFECTS ✓ MAJOR DEFECTS ✓ MINOR DEFECTS

5. Critical
Defect
• Life threatening and require the
company to take immediate action
by all reasonable means, whether in
or out of business hours.
• Product labelled with incorrect
name or incorrect strength.
• Counterfeit or deliberately tampered
with product.
• Microbiological contamination of a
sterile product

6. Major
Defect
• May put the patient at some risk but are
not life-threatening and will require that
batch recall or product withdrawal
within a few days.
• Any labeling/leaflet misinformation (or
lack of information) which represents a
significant hazard to the patient
• Microbial contamination of non-sterile
products with some risk for patients.
• Non-compliance to specifications (e.g.
active ingredients assay).

7. Minor
defects
• Present only a minor risk to the patient-
batch recall or
• product withdrawal would normally be
initiated within a few days.
• Readily visible isolated
packaging/closure faults.
• Contamination which may cause
spoilage or dirt and where there is
minimal risk to the patient.

8. Key points for handling Complaints
• Don’t take it personally.
• Never act on a complaint without hearing (at least) two
sides to the story.
• Say what you will do and do what you say; set the time
frame
• Keep notes

9. Contents of a product complaint data sheet
Serial number assigned to the complaints
• Exact nature of the complaints
• Name of the complainants
• Address of the complainants
• Date of the complaint received
• Name of the product, strength & batch number of the product
• Quantity involved in the complaint
• Size of the sample obtained by QC department
• Name and signature of the investigator & date.
• Action taken by the company
• Copy of reply sent to complaints

10. Steps involved in handling of complaints/ Evaluation

11. Steps involved in handling of complaints/ Evaluation
1. Receiving Complaints
Fig. 1: Receiving of complaints

12. Steps involved in handling of complaints/ Evaluation
1. Receiving Complaints
It is important to have a open channels with customers in order to
receive their suggestions, doubts and complaints. Generally, these
channels are toll free number, e-mails, chat rooms and P.O. boxes.
Whatever the channel, it is necessary to have a person in charge of
receiving the complaints and inputting them into an appropriate
investigation form that shall be addressed to the Quality assurance unit
for investigation.

13. Steps involved in handling of complaints
2. Technical Investigation
Upon receipt of the investigation form, the QA unit is able to
start the investigation, which can be divided into two phases:
documentation-based and laboratory analysis.
Fig. 2: Technical Investigation of complaints

15. Steps involved in handling of complaints
2. Technical Investigation
After receiving the analytical results, there are three possible
conclusions, as follows:
I. Confirmed Complaint
II. Non-Confirmed complaints
III. Counterfeit/Tamper suspicion

16. Steps involved in handling of complaints
3. Corrective Actions and Preventive Actions
Corrective Actions: eliminate detected non-conformity
• It aims to correct an existing non-conformity and to avoid
reoccurrence of the same non-conformity.
• Examples: arises from manufacturing deviations, OOS
investigations, complaints audit findings, recalls.
Fig. 3: Corrective Action and feedback to customers

17. Steps involved in handling of complaints
3. Corrective Actions and Preventive Actions
Preventive Actions: Prevent Non-Conformity occurrence
• It aims to avoid the initial occurrence of a non-conformity by pro-
actively implementing improvements.
• Examples: results from trending in process data, of analytical data,
of audit findings, trending of root causes for non-conformities or
complaints, from product quality reviews (annual product reviews),
quality risk analysis.

18. Steps involved in handling of complaints
3. Corrective Actions and Preventive Actions
• For all confirmed complaints, corrective actions must be
implemented.
• These actions can range from a simple and quick training to
some employees to a formal Corrective action and Preventive
active (CAPA) handling.
• The criteria for choosing appropriate action depends on the
nature of the complaint, and the complaint incidence.
• If a CAPA is opened, a multidisciplinary team consisting of
representatives of QA, QC, Regulatory affairs and Production
Management must be established.

19. Steps involved in handling of complaints
3. Corrective Actions and Preventive Actions
• Concerning non-conformed complaints originating from the
misuse or inadequate handling of the drug product, even if there
is no need for internal corrective actions, corrective measures
should be implemented to provide orientation to the customer.
• Regarding counterfeit or tampered suspicious complaints, a
response letter should also be sent to the customer, but the legal
affairs unit must be copied for further arrangements.

20. Steps involved in handling of complaints
4. Feedback to Customers
As feedback to the customer, the company must write a response
letter to the complaint to explain the investigation approach taken,
the results obtained and any implications, in case the quality
problem was confirmed. The customer should be sent a free
replacement product together with the response letter, since the
customer returned to the product (the Complaint Sample) to the
company for analysis and a quality problem was found.

21. Steps involved in handling of complaints
5. Monthly reports and trend Analysis
Monthly reports should be elaborated in order to evaluate the
amount and the nature of the complaints received and to perform a
trend analysis of these complaints.

22. Recordings of Complaints
• Name, dosage form, package form, batch no.
• Date and the place of occurrence of complaints
• Cause of complaints
• Name and address of complaint in detail
Content Complaints
• Regarding market place, circulation condition and condition in which the
defect was observed.
• Results of investigation of analysis and testing records, production and storage
records
Results of investigation
Evaluation
• Reply to the complainant.
• Remedial action so that complaint of this type should not reoccur.
Follow up measures

23. SOP for handling complaint
 A well-documented standard operating procedure (SOP) enables
handling of complaint
 Streamlines the lifecycle from event receiving, through
investigation, root cause analysis, corrective and preventive action
and reporting to regulatory agencies.
 Adherence of an effective complaint handling system is more than

24. SOP for handling complaint
 Adherence of an effective complaint handling system is more than
just a requirement
 It is a good practice that can help assure a manufacturer's product
to continue to meet quality attributes after it leaves premises.

25. SOP for handling complaint
Key parts of a complaint handling program must be formulated by
including following aspects in the form of Standard Operating
Procedure (SOP) to:
• Describe the mode of receipt of
complaint
• Define the complaint login system
• Acknowledge of complaint
• Assigning of responsibilities of
team for complaint handling
• Request for complaint sample or
photograph
• Review of batch documents.
Comparison with retention samples
• Review of stability samples
• Investigation approach and tools
• Establishing root cause
• Formulating corrective action and
preventive action (CAPA)
• Response to complainant
• Set the time lines for
implementing CAPA
• Periodic trend analysis of
complaints.

26. Handling of return goods
 Pharmaceutical products can be returned from market for various
reasons
eg. Quality problems, accidental damage of goods, stability
related issues or any other such reason.

27. Handling of return goods
 The following action is immediately taken on such goods/products:
i) Physically examine the condition of the goods
returned. Also check all the relevant documents.
ii) Ask Quality control department to evaluate the quality
of the goods received and take a decision on whether
these products can be reprocessed, recovered or needs
to be destroyed.

28. Handling of return goods
 The following action is immediately taken on such goods/products:
iii. If it possible to reprocess and recover, then such products
after reprocessing or retesting may be considered for
relabelling, repacking and reselling the same.
iv. Quality control department should evaluate all aspects of the
received .material.

29. Handling of return goods
 The following action is immediately taken on such goods/products:
v. Where even a slightest doubt arises about the quality of the
product, it should not be considered suitable for reissue or
reuse.
vi. Any action taken should be recorded.

30. Handling of return goods
 Returned products should be stored in separate area.
 It should be destroyed unless it is certain that their quality is
satisfactory.
 If their quality on evaluation is found satisfactory these may be
considered for:
Resale, Relabeling, Bulking with subsequent batch

31. Handling of return goods
Classification of returned goods:
Returned goods are classified based on following conditions:
1. Date of expiry products
2. Damaged primary containers
3. Broken seals or closures of primary containers
4. Mutilated labels
5. Soiled labelling
6. Products recalled voluntarily
7. Products recalled as per directives from drug control authorities

32. Handling of return goods
Record of return goods
It includes:
The name and label claim / potency of the drug product / dosage form
Lot number / batch number of drug product
Reason for return
Quantity returned
Date of disposition
Ultimate disposition of the return drug product.

33. PRODUCT RECALL/WITHDRAWAL
Process for withdrawing or removing a pharmaceutical product from the pharmaceutical
distribution chain because of defects in the product, complaints of serious adverse reactions to
the product and/ or concerns that the product is or may be counterfeit. The recall might be
initiated by the manufacturer, wholesale dealer licence holder, or Department of Health.
Definitions: Recall - means the removal of specific batch/batches of a medicinal product from
the market for reasons relating to deficiencies in the quality, safety or efficacy.
Withdrawal - means the total withdrawal of a medicinal product from of the market.

34. PRODUCT RECALL/WITHDRAWAL
Reasons for Recall / withdrawal of Product:
• Reports of adverse drug reactions not included in the package insert
• Unexpected frequency of adverse reaction stated in the package insert
• Incorrect labelling of a product
• Incorrect formulation of a product
• Result of ongoing stability studies

35. PRODUCT RECALL/WITHDRAWAL
Recall Classification:
The following classification criterion is recommended by WHO:
Class I: Class 1 is for defective/dangerous/potentially life-threatening medicines
that predictably or probably could result into serious health risk/adverse events or
even death.
Class II: Class II in for medicines that possibly could cause temporary or
medically reversible adverse health problem or mistreatment.
Class III: Class III is for medicine that is defective and is unlikely to cause any
adverse health reaction or which do not comply with the requirements of the
Pharmacy and Poisons Act, cap 244 Laws of Kenya, in terms of the requirements
of printed packaging material, product specification, labelling, etc.

36. PRODUCT RECALL/WITHDRAWAL
Basic information required for recall
 Name, strength, pack size, batch/lot number and any means of identification of
the recalled product
 Total quantity of the product being recalled originally in of the company
 The date distribution of the product began
 The total quantity of the product being recalled that had been distributed up to
the time of the recall should be indicated.
 Area of distribution of the product and, if exported, the cou to where it was
exported.

37. PRODUCT RECALL/WITHDRAWAL
Basic information required for recall
 Name, strength, pack size, batch/lot number and any means of identification of
the recalled product
 Total quantity of the product being recalled originally in of the company
 The date distribution of the product began
 The total quantity of the product being recalled that had been distributed up to
the time of the recall should be indicated.
 Area of distribution of the product and, if exported, the country to where it was
exported.

38. PRODUCT RECALL/WITHDRAWAL
Basic information required for recall
 List of customers to whom product was issued.
 The quantity of the recalled product still in their possession
 The reason for initiating the recall; nature of defect
 Suggested action to be taken and its urgency
 Indication of the health risk together with reasons.

39. PRODUCT RECALL/WITHDRAWAL
Stages of recall procedure:
In formulating a recall strategy, the following should be taken into consideration
o Result of health hazard evaluation
o Ease in identifying the product
o Extent to which the product deficiency is obvious to the consumer/ user
o Continued availability of essential products (risk: benefit)

40. PRODUCT RECALL/WITHDRAWAL
The procedure is divided into six stages:
Stage-1
• Receipt of Pharmaceutical Product Problem Report: Notification to the Department of Health Information
on problem of pharmaceutical products.
Stage-2
• Initiation of a Recall Information: Required for Assessment of Recall Information on product, problem and
distribution is required.
Stage-3
• Assessment of Recall: The classification, level and strategy of recall are determined depending on the
potential hazard of defective product and the extent of product distribution.
Stage-4
• Recall Letters and press release (if required) are dispatched to relevant firms for notifying on the recall.
Stage-5
• Progress of Recall and Report Progress reports and final report are submitted to the Drug Office.
Stage-6
• Evaluation of the Recall: The effectiveness of the recall monitored by the Drug Office.

41. Implementation of recall
communication:
 Telephone
 Telex
 Telegram
 Public media
 Special delivery
Contents of recall communication:
1. Be brief and to the point
2. Name the product, strength, pack
size, and any other pertinent
descriptive information of the
product
3. Indicate nature of the defect
4. Specify urgency of the action
5. Indicate reason for the action
6. Indicate the health risk; and
7. Provide specific instructions on
what should be done with the
recalled product.

42. PRODUCT RECALL/WITHDRAWAL
WHO guidelines for Recall:
 System to recall from the market
 The authorized person should be responsible for the execution and
coordination of recalls.
 Established written procedures, which are regularly reviewed and updated, for
the organization of any recall activity.
 An instruction should be included in the written procedures to store recalled
products in a secure segregated area

43. PRODUCT RECALL/WITHDRAWAL
WHO guidelines for Recall:
 A competent authorities of all countries to which a given product has been
distributed should be promptly informed of any intention to recall the product
because it is, or is suspected of being, defective.
 The distribution records should be readily available to the authoring person,
 The progress of the recall process should be monitored and recorded.
 Records should include the disposition of the product.
 The effectiveness of the arrangements for recalls should be tested annd
evaluated from time to time.

44. WASTE DISPOSAL
Pharmaceutical waste is any waste that contains medicinal drugs that an expired,
unused, contaminated damaged or no longer needed.
In accordance with the Section 47.5 of Waste Prevention and Management
Regulation 2012, Pharmaceutical waste includes medicines, biological products
(blood, serum, vaccine) which are expired, incompletely used damaged, spilled,
rejected medicinal products, and recalled medicinal products.

45. WASTE DISPOSAL
Procedure for disposal of pharmaceutical waste
1. Segregation at Source
i. Packaging materials.
ii. Hazardous Waste
iii. Non-Hazardous waste
2. Transportation to Collection Store
3. Transportation to Disposal Site

46. WASTE DISPOSAL
 Disposal Methods
A. Hazardous Waste: Encapsulation and Landfill. It should be
immobilized or encapsulated prior to disposal. The wastes should be
mixed with cardboard, and possibly with other combustible ideal for
incineration. The residues of incineration should be land filled.
B. Non-Hazardous Solid waste: Landfill Non-hazardous pharmaceuticals
should be disposed off in a solid land fill, as identified by the local
Health Administration Head or Local municipality.

47. WASTE DISPOSAL
 Disposal Methods
C. Non-Hazardous Liquid Solid waste:
i. Non- hazardous pharmaceutical liquid dosage form waste such as
large volume parenteral fluids (salts, amino acids, lipids, glucose),
vitamins & eye drops (but not antibiotics or cytotoxic drugs can be
diluted (dilution factor water in 1:3 Ratio) and flushed into the sewers
in small quantities.
ii. Fast flowing water sources should be used to flush the diluted and
pharmaceutical wastes.

48. WASTE DISPOSAL
 Disposal Methods
C. Non-Hazardous Liquid Solid waste:
iii. Don’t discharge even small quantities of pharmaceutical slow-moving
or stagnant water bodies.
iv. Non-hazardous liquid waste other than large volume parenteral (salts,
amino acids, lipids, and glucose), vitamins and eye drops should land
filled as it is.

49. WASTE DISPOSAL
Recording and reporting of Medical waste
Important for the future planning on infrastructure, logistics and manpower.
Also serve the purpose of monitoring the compliance to the Medical waste
management guideline.
Waste generated from all units and taken to the storage facility should be
individually weighed and reported as per the recording and reporting form.
1. Weighing of waste: Equipment’s, Methods to weigh waste
2. Responsible persons
3. Frequency of reporting