Pharmaceutical post operational activities

Market complaint Pharmaceutical Post-operational Activities

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

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

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

Classification of complaint Pharmaceutical Post-operational Activities

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

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

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

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

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

Handling of market complaint Pharmaceutical Post-operational Activities

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

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

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

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

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

PRODUCT RECALL Pharmaceutical Post-operational Activities

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Pharmaceutical Post-operational Activities