pharmaceutical post-operational activities 1 pharmaceutical post operational activities

Pharmaceutical Post-operational Activities 1

Pharmaceutical post operational activities


MARKET COMPLAINT


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.


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.


RESPONSIBILITY: Company employees, representatives

and distributors, Customer Action Report (CAR) Coordinator

The QA/QC Manager

Assigned complaint investigators

Document Control


CLASSIFICATION OF COMPLAINT


1. CRITICAL COMPLAINT: E.g. October 05, 2012 Hospira recalls one lot of ‘Lacteted

Ringer’s & 5% Dextrose Injection’, USP, 1000ml.


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’


3. MINOR COMPLAINT: E.g. Empty pocket in blister Broken tablet


TYPES OF COMPLAINT: Reagent problem Device problem Hardware problem Software problem Packaging problem Labeling / procedural problem Service problem Processing problem Operator Error


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


HANDLING OF MARKET COMPLAINT


PROCEDURE:Step I: Receiving complaints

Step II: Technical Investigation

Step IV: Monthly report & trend analysis


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


Step 2: Technical Investigation

Start the investigation

DOCUMENTATION- BASED

LABORATORY ANALYSIS

QA COMPLAINT OFFICER


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


PRODUCT RECALL


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.


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


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.


RESPONSIBILITY:

Registrar

Pharmaceutical Inspectorate Secretariat

Pharmacy and Poisons Board


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


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


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.


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.


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…


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)


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


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.


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


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…


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 1 pharmaceutical post operational activities

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