1. Pharmaceutical post operational activities
By- Mr. Sagar M. Mhaske

2. A SEMINAR ON Pharmaceutical post operational activities
PRESENTED BY
Mr. Alhat M.V.
M. Pharm.(Q.A.T.)
1st SEM., Roll no. 01
GUIDED BY
Prof. Mr. S. A. Hapase
Q.A.T. Department
P.D.V.V.P.F’s COLLEGE OF PHARMACY, VILAD GHAT, AHMEDNAGAR.
Pharmaceutical Post-operational Activities

3. Market complaint
Pharmaceutical Post-operational Activities

4. 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

5. Objectives:
To identify the key issues in product complaint and recall 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

6. Responsibility:
Company employees, representatives and distributors are responsible for reporting all customer complaints to Customer Service or local Customer Action Report (CAR) Coordinator.
The QA/QC Manager is responsible for determining whether a complaint requires review by Material Review Board.
Assigned complaint investigators are responsible for completing and documenting the investigation in a timely manner.
Pharmaceutical Post-operational Activities

7. Continued…
Document Control is responsible for the retention of all original complaint records and reports.
Pharmaceutical Post-operational Activities

8. 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

9. 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

10. Market complaint handling
Pharmaceutical Post-operational Activities

11. 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

12. 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

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

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

15. 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

16. Product recall
Pharmaceutical Post-operational Activities

17. Definition:
A recall is defined as the Company’s removal of a marketed product because of design or production defects that may compromise safety, efficacy and purity of the product or because of Government regulation.
Pharmaceutical Post-operational Activities

18. Objectives:
Stop the distribution and sale of the hazardous and unsafe products and minimize the risk of injury or death to the consumer.
Inform the public and the appropriate authorities of the problem.
Effectively and efficiently remove potentially unsafe product from the market place.
Minimize the cost and inconvenience to consumers and the industries.
Minimize the need for involving the relevant Government department and agencies by voluntary complying with the low.
Pharmaceutical Post-operational Activities

19. Purpose:
To withdraw the product from the market this will or 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 declaring the goods to be hazardous and unsafe.
Pharmaceutical Post-operational Activities

20. 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

21. 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

22. 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

23. Detection of GMP Failure- The photo shows an active tablet in the row of placebos in a bi-phasic oral Contraceptive blister pack
Pharmaceutical Post-operational Activities

24. 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

25. 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

26. 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

27. 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

28. 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

29. 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

30. 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

31. Reference:
Pharmaceutical Post-operational Activities

32. Thank you!!!
Pharmaceutical Post-operational Activities