Distribution.....cs..ppt

Seminar On Distribution And Distribution Record, Handling Of Returned Goods, Recovered Material And Reprocessing :

Seminar On Distribution And Distribution Record, Handling Of Returned Goods, Recovered Material And Reprocessing Guided by: Mr. Pinak R. Patel Assistant Professor M. Ph. Pharmaceutical Chemistry Department. Presented by: Chirag J. Solanki M. Ph. (QA Dept.) Roll No: 11, 2010-11 cs_apc_09@yahoo.in Dharmaj Degree Pharmacy College, Dharmaj.

contents:

contents Distribution Distribution records Handling of return products Recovered material and reprocess

Distribution :

Distribution Definition: The division and movement of the pharmaceutical products from the premises of the manufacturer of such products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments

Introduction:

Introduction Distribution forms an important activity of the integrated supply chain management of pharmaceutical products . The guidelines are intended to apply to all steps in the entire distribution/supply chain. The storage, trade and distribution of pharmaceutical products are activities that are carried out by various companies, institutions and individuals. There are some aspects in distribution to which the principles of good manufacturing practice (GMP) should be applied.

Organization and management :

Organization and management M ust be an entity that is appropriately authorized to perform the intended function. Adequate organization structure, organization chart and responsibility, authority and interrelationships of all personnel should be clearly defined. A designated person should be appointed at each distribution point

Personnel :

Personnel Adequately trained in the requirement of GDP. Key personnel must have enough ability and experience. Adequate number of personnel.

Premises, Warehousing and storage:

Premises, Warehousing and storage Good storage practice (GSP) is applicable in all circumstances Precaution must be taken to prevent unauthorized persons from entering storage areas. Storage area should be of sufficient capacity. Storage area should be designed or adapted to ensure good storage conditions.

Vehicles and Equipment:

Vehicles and Equipment S hould be suitable for their use and appropriately protective. The design and use aim to minimize the risk of error and permit effective cleaning and/or maintenance. Dedicated vehicles and equipment should be used.

Containers and Container labeling:

Containers and Container labeling Containers should be protective in nature. Labels applied to container should be clear, unambiguous, permanently fixed to the container and be indelible. Shipping containers may not need to bear labels with full description.

Dispatch:

Dispatch Pharmaceutical product should only be sold and/or distributed to persons or entities that are entitled to acquire such products. The supplier of pharmaceutical products should ensure that the person or entity is aware of appropriate storage and transport conditions .

DISTRIBUTION CHANNEL:

DISTRIBUTION CHANNEL These guidelines are intended to be applicable to all persons and companies. This include all the parties involved in the trade and distribution, pharmaceutical manufacturer, including the manufacturer of finished products, brokers, suppliers, distributors, wholesalers , traders, transport companies, forwarding agents, etc. The guideline can also be used as a tool in the prevention of the distribution of counterfeit and substandard medicines.

Distribution records :

Distribution records

Slide 14:

Distribution records include a wide range of documentation such as invoices, bills of lading, customers’ receipts, and internal warehouse storage and inventory records The primary purpose of this section is to ensure that adequate data are available so that recall should be initiated.

WHO Guideline For Distribution Records:

WHO Guideline For Distribution Records Written instructions and records should be available Procedure should be established and maintained Documents should be designed, reviewed and distributed with care . The title, nature and purpose of each document should be clearly stated The content of document should be clear and unambiguous. Documents should be laid out in an orderly fashion and be easy to check . All documents should be completed, approved, signed (as required) and dated by an appropriate authorized persons .

Slide 16:

There should be compliance with national legislative requirements with regard to the nature, content and retention of documentation, relating to the distribution of pharmaceutical products The distributor must establish and maintain procedures for the identification, collection, indexing, storage, maintenance, disposal of and access to all applicable documentation. All record must be readily retrievable, stored and retained using facilities. Documents should be reviewed regularly and kept up to date . Mechanisms should exist to allow for transfer of information.

Slide 17:

Records should be kept and be readily available upon request. In the case of temperature-sensitivity pharmaceutical products, records of investigations and actions should be retained for at least one year after the expiry date of the product. Where the records are generated and kept in electronic for, their back-ups should, be available to prevent any accidental data loss.

HANDLING OF RETURNED GOODS:

HANDLING OF RETURNED GOODS Objective Authority and responsibility CLASSIFICATION OF RETURNED GOODS: Date expired goods. Damaged or broken primary containers. Leaky or broken seals of primary containers. Mutilated labeling: product unidentifiable. Soiled labeling: product identifiable. Product recall voluntarily. Product recall on the advice of drug controller authority

Slide 19:

RETURNED GOODS HANDLING PROCEDURE All the returned goods shall be properly: Documented Inspected Accounted Labeled (to identify the primary cause for their return) Segregated/quarantined till further and final action. It must be ensured that irrespective of the cause of returned and subsequent actions taken by the company, it is mandatory that. Statutory requirements are adhered to. All operations/actions are well documented.

DATE EXPIRED GOODS:

DATE EXPIRED GOODS

Slide 21:

DAMAGED/BROKEN PRIMARY CONTAINER Examination by designated person. Opinion by designated person . If necessary then destroyed. LEAKY/BROKEN SEALS OF PRIMARY CONTAINERS MUTILATED LABELING: Product unidentifiable

SOILED LABELING: Product identifiable :

SOILED LABELING: Product identifiable PRODUCT RECALL VOLUNTARILY ON ADVISE TO THE DRUG CONTROLLER AUTHORITY:

RECOVERED MATERIAL AND REPROCESSING :

RECOVERED MATERIAL AND REPROCESSING Objective Scope and applicability Definitions: Re-treatment Re-processing Reworking Recovery

Slide 24:

RE-PROCESSING: Re-processing is the act of repeating process steps that are part of the established manufacturing process for product RE-WORKING: Reworking subjecting all or part of a batch of product that does not conform to standards or specification to one or more processing steps that are different from the established manufacturing process to obtain an acceptable quality product.

Slide 25:

Suitability for retreatment Before a decision is taken to retreat a product, its feasibility should be technically assessed and the assessment approved by quality assurance. All retreatment should have acceptable implications regarding safety, health and environment. Retreated product should not be treated for second time.

Batch re-processing:

Batch re-processing Minimum value should be there for reprocessing. The reason/causes should be thoroughly investigated. Documentation of reprocessing. After reprocessing all release specifications must be obtained without altering its stability behavior. The need for additional testing of any finished product which has been re-processed must be considered. Sometimes the original release specification of the product may not be applicable to the re-processed product.

Control of Retreated Products :

Control of Retreated Products Any batch of product that has undergone a retreatment procedure must be clearly identified in its batch documentation review by QA. Retreated batches whether bulk, formulated or packed stock must conform to all established specifications. Any possible market restriction imposed by regulatory authorities must be considered before release of the product. Product that has exceeded its shelf life/expiry date should not be retreated under normal circumstances.

References:

References Wiling S. H., Stocker J. R.; Good Manufacturing Practice for Pharmaceutical; Marcell Dekker; Inc. New York; 4 th edition. Quality Assurance guide, Organization of Pharmaceutical Producers of India, Mumbai, 4 th Edition, 2001, Vol-2, Chapter 12, 14. http//www.health.gov.ildownloadformsa.pdf www.oraclemarketing.com/pharma/presentation/DI_08.30_Track_Manufacturing_John_Danese_oracle.pdf www.yvqm.com

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