1. Pharmaceutical post operational activities

2. Market complaint
Pharmaceutical Post-operational Activities

3. Definition:
Complaint is defined as any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance device after it is released for distribution.
Pharmaceutical Post-operational Activities

4. Objectives:
To identify the key issues in product complaint and complaint handling.
To understand the specific requirements for organization, procedures and resources.
To understand and develop actions to resolve current issues applicable to you.
Pharmaceutical Post-operational Activities

5. Responsibility:
Company employees, representatives and distributors, Customer Action Report (CAR) Coordinator
The QA/QC Manager
Assigned complaint investigators
Document Control
Pharmaceutical Post-operational Activities

6. Classification of complaint
Pharmaceutical Post-operational Activities

7. 1. Critical complaint:
E.g. October 05, 2012 Hospira recalls one lot of ‘Lacteted Ringer’s & 5% Dextrose Injection’, USP, 1000ml.
Pharmaceutical Post-operational Activities

8. 2. Major complaint: E.g. October 19, 2011
Insight Pharmaceuticals recalls ‘Nostrilla Nasal Decongestant’
September 04, 2012
Sun Pharmaceutical Industries, Inc. recalls one lot of ‘Nimodipine Capsules’
Pharmaceutical Post-operational Activities

9. 3. Minor complaint: E.g. Empty pocket in blister Broken tablet
Pharmaceutical Post-operational Activities

10. Types of complaint: Reagent problem Device problem Hardware problem
Software problem
Packaging problem
Labeling / procedural problem
Service problem
Processing problem
Operator Error
Pharmaceutical Post-operational Activities

11. Complaint sources: Complaints may be received from-
Customers by letter, credit memo, returned goods form, or phone;
A manufacturer’s representative, or other employees;
A service or repair request;
Journal articles;
The FDA
Pharmaceutical Post-operational Activities

12. Handling of market complaint
Pharmaceutical Post-operational Activities

13. Procedure: Pharmaceutical Post-operational Activities
Step I: Receiving complaints
Step II: Technical Investigation
Step III: Corrective actions & feed back to customers
Step IV: Monthly report & trend analysis
Pharmaceutical Post-operational Activities

14. COMPANY’S CONTACT PERSON
Step 1: Receiving complaints
CUSTOMER
Make a complaint through toll-free no., e- mails, P. O. Box
COMPANY’S CONTACT PERSON
Open the investigation form,
including information about
the customer and information
about the complaint.
Ask the customer to return
the product to the company
for analysis QA
COMPLAINT
OFFICER
Pharmaceutical Post-operational Activities

15. Step 2: Technical Investigation
Start the investigation
DOCUMENTATION- BASED
LABORATORY ANALYSIS
QA COMPLAINT OFFICER
Pharmaceutical Post-operational Activities

16. step 3: corrective actions and feedback to customers
CONFIRMED COMPLAINTS
NON CONFIRMED COMPLAINTS
COUNTERFEIT
step 3: corrective actions and feedback to customers
CORRECTIVE ACTIONS
FEEDBACK TO THE CUSTOMER
Step 4: Monthly reports
Pharmaceutical Post-operational Activities

17. Complaint records: Sequential number of complaints
Origin of the complaint
Customer information
Product information
Any corrective actions already taken
Details of the complaint
Dates, signatures, assignments, etc
Instructions
Investigations
Analyses
Conclusions
Corrective actions with respect to product & to the consumer
Pharmaceutical Post-operational Activities

18. PRODUCT RECALL
Pharmaceutical Post-operational Activities

19. Definition:
Product recall is defined as the removal of specific batch/batches of a medicinal product from the market for reasons relating to deficiencies in the quality, safety or efficacy.
Pharmaceutical Post-operational Activities

20. Objectives: Stop the distribution and sale of the unsafe products
Inform the public and the appropriate authorities
Effectively and efficiently remove potentially unsafe product from the market place
Minimize the inconvenience
Complying with the regulatory guidelines
Pharmaceutical Post-operational Activities

21. Purpose:
To withdraw the product from the market which may cause injury or death to person.
To withdraw the product from the market in respect of which there is a prescribe consumer product standard and the goods do not comply with the standard.
To withdraw the product from the market when there is notice in the National Gazette.
Pharmaceutical Post-operational Activities

22. Responsibility: Registrar Pharmaceutical Inspectorate Secretariat
Pharmacy and Poisons Board
Pharmaceutical Post-operational Activities

23. Types of recall: Type A Type B Type C
Action: Recall letter to all distribution points plus media release.
Type B
Action: Recall letter to all distribution points.
Type C
Action: Specific telephone calls, recall letters to/representatives calling at distribution points if known where the medicines have been distributed.
Pharmaceutical Post-operational Activities

24. Classification of recall:
For defective/dangerous/potentially life threatening medicines
Class II
For medicines that possibly could cause temporary or medically reversible adverse health problem or mistreatment.
Class III
For medicine that is defective and is unlikely to cause any adverse health reaction or which do not comply with the requirements of printed packaging material, product specification, labelling, etc.
Pharmaceutical Post-operational Activities

25. Reasons:
Serious reports of adverse drug reactions not included in the package insert
Unexpected frequency of adverse reaction stated in the package insert
Incorrect labeling of a product
Incorrect formulation of a product
Result of ongoing stability studies (unfavorable?)
Detection of GMP failure after release.
Pharmaceutical Post-operational Activities

26. Basic information for recall:
Name, strength, pack size, batch/lot number and any means of identification.
Total quantity of the product being recalled originally in possession of the company.
The date of distribution.
The total quantity of the product actually recalled which is already distributed.
Area of distribution.
List of customers.
Pharmaceutical Post-operational Activities

27. The quantity of the recalled product still in their possession.
Continued…
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
Pharmaceutical Post-operational Activities

28. Recall strategy:
In formulating a recall strategy, the following should be taken into consideration:
Result of health hazard evaluation
Ease in identifying the product
Extent to which the product deficiency is obvious to the consumer/user
Continued availability of essential products (risk: benefit)
Pharmaceutical Post-operational Activities

29. Product recall notification:
Public notification
Media release
Publicity material
Contents of notification:
It should be brief and to the point.
Name the product, strength, pack size
Indicate nature of the defect
Specify urgency of the action
Indicate reason for the action
Indicate the health risk
Pharmaceutical Post-operational Activities

30. Procedure: Head QA & QC will-
Investigate the market complaints, stability failure to evaluate the risk assessment.
Decide the type of recall in consultation with recall committee.
Communicate the decision of product recall with product details to Director – Operations / Distribution Manager / Contract Giver / Principal Company and Chief Executive Officer for information.
Pharmaceutical Post-operational Activities

31. Post recall procedure:
The report to contain the following information:
Name of the product
Strength of the product
Pack size
Batch/ lot number
Nature of the defect
Action that was taken
Urgency of the action taken
Reason for the action
Pharmaceutical Post-operational Activities

32. Indication of the health risk and reported clinical problems
Continued…
Indication of the health risk and reported clinical problems
Copies of all the recall correspondence;
And Steps taken to prevent re-occurrence of the problem
After termination of a recall and not later than 90 days after a recall has been instituted, a full reconciliation must be submitted.
Pharmaceutical Post-operational Activities

33. Reference:
Pharmacy and Poisons Board, Republic of Kenya, “Guidelines for Product Recall and Product Withdrawal”, First edition, June
Independent Consumer and competition commission, “Voluntary Product Recall Guide for Industries”, CPD – TMQCS 12 September
Dr. Sawant Ramesh, Prof. Hapse Sandip; “Fundamentals of Quality Assurance Technique”, Career Publication, First edition, December 2011, Page No.:
Potdar M. A., “Pharmaceutical Quality Assurance, Nirali Prakashan, Second edition, December, 2007, Page No.:
Pharmaceutical Post-operational Activities

34. Pharmaceutical Post-operational Activities