pharmaceutical post operational activities

PHARMACEUTICAL POST

OPERATIONAL ACTIVITIES

By- Mr. Sagar M. Mhaske

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A SEMINAR ONPharmaceutical 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.

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MARKET COMPLAINT

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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.

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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.

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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.

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Document Control is responsible for the retention of all original complaint records and reports.

Continued…

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

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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

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MARKET COMPLAINT HANDLING

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PROCEDURE:Step I: Receiving complaints

Step II: Technical Investigation

Step IV: Monthly report & trend analysis

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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

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Step 2: Technical Investigation

Start the investigation

DOCUMENTATION- BASED

LABORATORY ANALYSIS

QA COMPLAINT OFFICER

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CONFIRMED COMPLAINTS

NON CONFIRMED COMPLAINTS

COUNTERFEIT/ TAMPERSUSPICION

step 3: corrective actions and feedback to customers

CORRECTIVE ACTIONS

FEEDBACK TO THE CUSTOMER

Step 4: Monthly reports and trend analysis

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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

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PRODUCT RECALL

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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.

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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.

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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.

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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

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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

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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.

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Detection of GMP Failure-The photo shows an active tablet in the row of placebos in a bi-phasic oral Contraceptive blister pack

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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.

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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…

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RECALL STRATEGY:In formulating a recall strategy, the

followingshould 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)

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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

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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.

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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

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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…

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REFERENCE:

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Thank you!!!