Pharmaceutical Post-operational Activities 1
Pharmaceutical post operational activities
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:Step I: Receiving complaints
Step II: Technical Investigation
Step IV: Monthly report & trend analysis
Pharmaceutical Post-operational Activities 14
Step 1: Receiving complaints
CUSTOMER
COMPANY’S CONTACT PERSON
QACOMPLAINT
OFFICER
Make a complaint through toll-free no., e- mails, P. O. Box• 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
Pharmaceutical Post-operational Activities 15
Step 2: Technical Investigation
Start the investigation
DOCUMENTATION- BASED
LABORATORY ANALYSIS
QA COMPLAINT OFFICER
Pharmaceutical Post-operational Activities 16
CONFIRMED COMPLAINTS
NON CONFIRMED COMPLAINTS
COUNTERFEIT
step 3: corrective actions and feedback to customers
CORRECTIVE ACTIONS
FEEDBACK TO THE CUSTOMER
Step 4: Monthly reports
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 consumerPharmaceutical Post-operational Activities
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:
•Action: Recall letter to all distribution points plus media release.
Type A
•Action: Recall letter to all distribution points.Type B
•Action: Specific telephone calls, recall letters to/representatives calling at distribution points if known where the medicines have been distributed.
Type C
Pharmaceutical Post-operational Activities 24
CLASSIFICATION OF RECALL:
•For defective/dangerous/potentially life threatening medicines
Class I
•For medicines that possibly could cause temporary or medically reversible adverse health problem or mistreatment.
Class II
•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.
Class III
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.
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
Continued…
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:1. It should be brief and to the point.2. Name the product, strength, pack
size 3. Indicate nature of the defect4. Specify urgency of the action5. Indicate reason for the action6. 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
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.
Continued…
Pharmaceutical Post-operational Activities 33
REFERENCE: Pharmacy and Poisons Board, Republic of Kenya, “Guidelines
for Product Recall and Product Withdrawal”, First edition, June 2006.
Independent Consumer and competition commission, “Voluntary Product Recall Guide for Industries”, CPD – TMQCS 12 September 2005.
Dr. Sawant Ramesh, Prof. Hapse Sandip; “Fundamentals of Quality Assurance Technique”, Career Publication, First edition, December 2011, Page No.: 122-126
Potdar M. A., “Pharmaceutical Quality Assurance, Nirali Prakashan, Second edition, December, 2007, Page No.:10.2-10.4
http://www.fda.gov/drugs/drugsafety/DrugRecalls/default.htm
Pharmaceutical Post-operational Activities 34