The European Commission Health and Consumers Directorate – General has published a draft “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”.
The guideline addresses Quality systems, Personnel, Documentation, Order, Procedures, Records, Premises and Equipment, Receipts, Storage , Deliveries to Customers, Transfer of Information and Returns.
Following presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional.
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
FDA WARNING LETTER IS A OFFICIAL LETTER FROM USFDA TO A MANUFACTURING FIRM TO NOTICE THE SERIOUS VIOLATION FOUND AT THE FDA INSPECTION AT FIRM AND THE CORRECTIVE ACTION SHOULD TO TAKEN BY FIRM TO OVERCOME THE VIOLATION FOR FDA APPROVAL
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
FDA WARNING LETTER IS A OFFICIAL LETTER FROM USFDA TO A MANUFACTURING FIRM TO NOTICE THE SERIOUS VIOLATION FOUND AT THE FDA INSPECTION AT FIRM AND THE CORRECTIVE ACTION SHOULD TO TAKEN BY FIRM TO OVERCOME THE VIOLATION FOR FDA APPROVAL
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
Quality Management system in accordance to Vol. 4 EU Guidelines for GMP for Medicinal Products for Human and Veterinary Use Chapter 1 Pharmaceutical QS
ICH Q10/ Q7.
ISO 9001/2015
Master batch record,batch production record ,Quality Audit Type and plan &Rec...KarishmaFuse
Standard Operating procedure(SOP), Preparation review ,Approval Issuance of master batch Record MBR and Batch Production Record (BPR) and Quality Audit Type, plan and Objectives.
Quality Management system in accordance to Vol. 4 EU Guidelines for GMP for Medicinal Products for Human and Veterinary Use Chapter 1 Pharmaceutical QS
ICH Q10/ Q7.
ISO 9001/2015
Master batch record,batch production record ,Quality Audit Type and plan &Rec...KarishmaFuse
Standard Operating procedure(SOP), Preparation review ,Approval Issuance of master batch Record MBR and Batch Production Record (BPR) and Quality Audit Type, plan and Objectives.
Marv Shepherd, PSM president, Member USP Package Storage and Distribution Expert Committee, and Professor at the University of Texas at Austin speaks about updates to United States Pharmacopeia's good distribution practices.
Leading Practices for Distribution SuccessNet at Work
As the pace of change in business accelerates—especially for those still relying on aged, on-premise ERP systems, wholesale distributors are struggling to keep up. Today’s leading distribution businesses need a proven solution that can be deployed quickly, predictably, and affordably, setting you up for growth and success.
[Infographic] A One Page Guide to Global GDP GuidelinesPharma IQ
http://www.coldchainiq.com/regulatory-resources/white-papers/a-one-page-guide-to-global-gdp-guidelines/
All GDP guidelines in one single place!
Good Distribution Practice (GDP) is the part of quality assurance which ensures that products are consistently stored, transported and handled under suitable condition as required by the marketing authorisation (MA) or product specification. There is no single global GDP standard. Cold Chain IQ has created this easy to-assimilate summary of GDP requirements around the world, enabling you to navigate the landscape. You can keep it as a handy reference, share it around your colleagues or even stick it on your wall!
The purpose of Gap Analysis is to assist pharmaceutical manufacturers, distributors or 3 PLs (3rd Party Logistics Providers) to help them identify gaps in their cold chain supply chain network or systems.
What you will learn:
* The regulatory aspects related to the cold chain
* Responsibilities in the supply chain
* Requirements for the storage and handling of drug products
* Packaging, transportation and distribution of drug products
* Performing a gap analysis to know what needs to be done in order to fully comply with regulations and optimize your processes
* Ways and means to develop an executable action plan
How you will benefit:
* Understand how to execute a cold chain regulatory gap analysis
* Discover what should be covered when looking at cold chain compliance
* Gap analysis: The first step to develop a cold chain compliance program
* Uncover the requirements for the storage and distribution of drug products
* Sharing the responsibilities for a good cold chain compliance
It is of key importance that the quality and the integrity of the medicinal products are maintained during the entire supply chain from the manufacturer to the patient. Today’s distribution network for medicinal products is increasingly complex and involves many players. The revised guidelines, published today, lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain.
The revised guidelines introduce the following changes:
the maintenance of a quality system setting out responsibilities, processes and risk management principles in relation to wholesale activities;
suitable documentation which prevents errors from spoken communication;
sufficient competent personnel to carry out all the tasks for which the wholesale distributor is responsible;
adequate premises, installations and equipment so as to ensure proper storage and distribution of medicinal products;
appropriate management of complaints, returns, suspected falsified medicinal products and recalls;
outsourced activities correctly defined to avoid misunderstandings;
rules for transport in particular to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport;
Specific rules for brokers (person involved in activities in relation to the sale or purchase of medicinal products)
Drug Regulations has prepared a presentation summarizing the new GDP requirements for Medicinal Products.
The European Commission Health and Consumers Directorate – General has published draft “GUIDELINES ON THE FORMALISED RISK ASSESSMENT FOR ASCERTAINING THE APPROPRIATE GOOD MANUFACTURING PRACTICE FOR EXCIPIENTS OF MEDICINAL PRODUCTS FOR HUMAN USE” for public consultation.
Following presentation has been prepared by " Drug regulations" a not for profit organization which provides free online resources for the Pharmaceutical Professional.
A primary mission of the Food and Drug Administration is to conduct comprehensive regulatory coverage of all aspects of production and distribution of drugs and drug products to assure that such products meet the 501(a)(2)(B) requirements of the Act. FDA has developed two basic strategies:
. 1) evaluating through factory inspections, including the collection and analysis of associated samples, the conditions and practices under which drugs and drug products are manufactured, packed, tested and held, and
. 2) monitoring the quality of drugs and drug products through surveillance activities such as sampling and analyzing products in distribution.
FDA compliance program “ Drug Manufacturing Inpsections” (7356.002) is designed to provide guidance for implementing the first strategy. Products from production and distribution facilities covered under this program are consistently of acceptable quality if the firm is operating in a state of control.
The inspectional guidance in this program is structured to provide for efficient use of resources devoted to routine surveillance coverage, recognizing that in-depth coverage of all systems and all processes is not feasible for all firms on a biennial basis. It also provides for follow-up compliance coverage as needed.
“Drug Regulations” has prepared a summary from the compliance programme and is given below in the presentation.
This presentation covers the manufacture and testing of all sterile drug products, including drugs that are sterilized by filtration or other means and aseptically processed, and drug products that are terminally sterilized. The type of products covered include sterile bulk drugs, ophthalmic drugs, otic dosage forms, small volume parenteral (SVS) products for small molecule and licensed biological
therapeutic drug products, large volume parenteral (LVP) products, and any other drug products required to be sterile or labeled as sterile. Center for Biologics Evaluation and Research (CBER) regulated products and veterinary drug products are excluded from coverage under this program.
The guidance information is tailored to sterile manufacturing operations and should be used in conjunction with the Compliance Program for Drug Manufacturing Inspections (CP 7356.002).
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
The European Commission has published the final EU Guidelines for Complaints, Quality Defects and Product Recalls.
Significant changes have been made to this Chapter which now reflect that Quality Risk Management principles should be applied when investigating quality defects or complaints and when making decisions in relation to product recalls or other risk-mitigating actions. This presentation captures the new requirements.
Presentation: Pharmacovigilance: The Australian landscapeTGA Australia
Overview of current post-market monitoring regulations and practice in Australia. Focusing on changing trends and the implications for future post-market vigilance practice.
A Closer Look At Brazil’s New Serialization RegulationShari Popovich
Brazil has gone through several attempts at defining its pharmaceutical serialization and traceability regulation. The newest version of the law requires ANVISA to develop new regulations, which should result in a more attainable architecture.
In this webinar, Dirk Rodgers, Regulatory Strategist at Systech International, will review the features of the new law and the recent draft of regulations from ANVISA. He will also give his quarterly overview of regulatory developments around the rest of the world.
This presentation highlights the reasons which lead to the withdrawal of the 2002 Guidance of the FDA and the current issue with Blend Uniformity and Content Uniformity Determinations.
WHO has recently issued draft document titled "Guidelines on Validation". These guidelines (i.e., the main text included in this working document) cover the general principles of validation and qualification.
These guidelines focus mainly on the overall concept of validation and are not intended to be prescriptive in specific validation requirements. This document serves as general guidance only and the principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs), as well as other areas. Validation of specific processes and systems, for example, in sterile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document. The general text in this document may be applicable to validation and qualification of premises, equipment, utilities, systems, processes, and procedures.
The draft on the specific topics, the appendices to this main text, will follow. The following is an overview on the appendices that are intended to complement the text of this working document:
Appendix 1: Validation of heating, ventilation and air-conditioning systems - will be replaced by cross reference to WHO Guidelines on GMP for HVAC systems for considerations in qualification of HVAC systems (update - working document QAS/15.639/Rev. 1)
Appendix 2: Validation of water systems for pharmaceutical use - will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems
Appendix 3: Cleaning validation - consensus to retain
Appendix 4: Analytical method validation - update in process
Appendix 5: Validation of computerized systems - update in process
Appendix 6: Qualification of systems and equipment - update in process
Appendix 7: Non-sterile process validation - update already published as Annex 3, WHO Technical Report Series, No. 992, 2015
Comments on this draft document are due by July 12, 2016.
A presentation on this guidance is given below:
Presentation on New WHO Guidance on Validations
Environmental Monitoring describes the microbiological testing under- taken in order to detect changing trends of microbial counts and micro- flora growth within cleanroom or controlled environments. The results obtained provide information about the physical construction of the room, the performance of the Heating, Ventilation, and Air-Conditioning (HVAC) system, personnel cleanliness, gowning practices, the equipment, and cleaning operations.
Over the past decade, environmental monitoring has become more sophisticated in moving from random sampling, using an imaginary grid over the room and testing in each grid, to the current focus on risk assessment and the use of risk assessment tools to determine the most appropriate methods for environmental monitoring.
This presentation gives current trends in the application of risk assessment to the practice of environmental monitoring.
This presentation is compiled from freely available resources like the websites of FDA, EMA ,WHO and research papers published by experts in this field like Sandle, T Reinmüller, B , Hyde, W,, Costello, E.K., Lauber, C. L., Hamady, M., Fierer, N., Gordon, J.I., Knight, R.
Paper published by T. Sandle on clean room contamination was referred extensively for this presentation. “Drug Regulations” is a non profit organization which provides free online resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals.
This presentation gives an overview of : Validation of microbiological methods , Considering some of the limitations and
Key criteria that may be applicable for assessment.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
HOT NEW PRODUCT! BIG SALES FAST SHIPPING NOW FROM CHINA!! EU KU DB BK substit...GL Anaacs
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We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Hemodialysis: Chapter 3, Dialysis Water Unit - Dr.Gawad
Good distribution practices for API's
1. This presentation is prepared by “ Drug Regulations” a
non profit organization which provides free online
resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of Pharmaceuticals.
3/29/2015 1
2. This presentation is compiled from freely available
resources like the website of EU , EMA , specifically
“Guidelines on principles of Good Distribution
Practice of active substances for medicinal
products for human use”
“Drug Regulations” is a non profit organization
which provides free online resource to the
Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of Pharmaceuticals.
3/29/2015 2
Drug Regulations : Online
Resource for Latest Information
3. “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION
PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL
PRODUCTS FOR HUMAN USE”
Published in February 2012
Comments were open till February 2013.
Final guidance published on in March 2015.
This presentation gives a summary of this guidelines.
3/29/2015 3
Drug Regulations - Online
Resource latest information.
4. Based on the fourth paragraph of Article 47 of
Directive 2001/83/EC
Follow principles of
◦ EudraLex Volume 4, Part II, Chapter 17, with regard to the
distribution of active substances and
◦ Guidelines of 5 November 2013 on Good Distribution Practice of
medicinal products for human use
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Drug Regulations - Online
Resource latest information.
5. Provide stand-alone guidance on Good Distribution
Practice (GDP)
To be followed by
◦ Importers and distributors of active substances for medicinal
products for human use.
◦ Distributors of active substances manufactured by themselves.
Complement rules on distribution set out in the
guidelines of EudraLex Volume 4, Part II
3/29/2015 5
Drug Regulations - Online
Resource latest information.
6. Commission Delegated Regulation (EU) No
1252/2014 (3) and EudraLex Volume 4, Part II are
applicable to
◦ Any manufacturing activities in relation to active substances
including
Re-packaging,
Re-labelling or
Dividing up
3/29/2015 6
Drug Regulations - Online
Resource latest information.
7. Additional requirements apply to the importation of
active substances, as laid down in Article 46b of
Directive 2001/83/EC.
3/29/2015 7
Drug Regulations - Online
Resource latest information.
8. These Guidelines are applicable as of
September 21 , 2015.
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Drug Regulations - Online
Resource latest information.
9. Applicable to distribution of active substances,
◦ Defined in Article 1(3a) of Directive 2001/83/EC, for
medicinal products for human use.
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Drug Regulations - Online
Resource latest information.
10. Active substances,
◦ An active substance is any substance or mixture of
substances intended to be used in the manufacture of a
medicinal product and that, when used in its production,
becomes an active ingredient of that product intended to
exert a pharmacological, immunological or metabolic
action with a view to restoring, correcting or modifying
physiological functions or to make a medical diagnosis.
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Drug Regulations - Online
Resource latest information.
11. Distribution of active substances shall comprise all
activities consisting of
◦ Procuring
◦ Importing
◦ Supplying or exporting active substances
◦ Brokering
Guidelines do not apply to intermediates of active
substances.
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Drug Regulations - Online
Resource latest information.
12. Develop and maintain a quality system
Set out responsibilities
Use process and risk management principles
Examples of quality risk management
◦ EudraLex Volume 4, Part III: GMP related documents
◦ ICH guideline on Quality Risk Management (ICH Q9).
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Drug Regulations - Online
Resource latest information.
13. Should be adequately resourced
Competent personnel
Suitable and sufficient premises
Equipment and facilities
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Drug Regulations - Online
Resource latest information.
14. Quality System should ensure that:
1. Active substances are procured, imported, held, supplied or
exported in a way that is compliant with the requirements of
GDP for active substances
2. Management responsibilities are clearly specified
3. Active substances are delivered to the right recipients within a
satisfactory time period
4. Records are made contemporaneously
3/29/2015 14
Drug Regulations - Online
Resource latest information.
15. Quality System should ensure that:
4. Deviations from established procedures are documented
and investigated;
5. Appropriate corrective and preventive actions, commonly
known as ‘CAPA’, are taken to correct deviations and
prevent them in line with the principles of quality risk
management;
6. Changes that may affect the storage and distribution of
active substances are evaluated.
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Drug Regulations - Online
Resource latest information.
16. Development & Modification of Quality
System
◦ Consider the size, structure and complexity of
the distributor’s activities
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Drug Regulations - Online
Resource latest information.
17. Designated person
◦ Appoint at each location where distribution activities
are performed
◦ Should have defined authority and responsibility
◦ Should ensure that a quality system is implemented
and maintained
◦ Should fulfil his responsibilities personally
◦ Designated person can delegate duties but not
responsibilities
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Drug Regulations - Online
Resource latest information.
18. Specify & document responsibilities of all
Should have the appropriate competence
and experience
Should ensure that active substances are
properly handled, stored and distributed.
3/29/2015 18
Drug Regulations - Online
Resource latest information.
19. Training
◦ Initial
◦ Continuing / ongoing
◦ Relevant to their role
◦ Based on written procedures
◦ In accordance with a written training programme
◦ Cover requirements of GDP
◦ Keep record of all training
◦ Assess effectiveness of training
◦ Document effectiveness assessment
3/29/2015 19
Drug Regulations - Online
Resource latest information.
20. Documentation
◦ Paper or in electronic data
◦ Written procedures
◦ Instructions
◦ Contracts
◦ Records
◦ Readily available
◦ Retrievable.
◦ Made available to competent authorities on request
3/29/2015 20
Drug Regulations - Online
Resource latest information.
21. Documentation
◦ Sufficiently comprehensive w r t distributor’s
activities
◦ In a language understood by personnel
◦ Clear, unambiguous language
◦ Free from errors
3/29/2015 21
Drug Regulations - Online
Resource latest information.
22. Documentation
◦ Any alteration should be signed and dated
◦ Any alteration should permit the reading of the
original information
◦ Reason for the alteration should be recorded
◦ Ready access to all responsible & accountable
3/29/2015 22
Drug Regulations - Online
Resource latest information.
23. Written
Describe distribution activities which affect
the quality of the active substances
◦ Receipt and checking of deliveries
◦ Storage
◦ Cleaning
3/29/2015 23
Drug Regulations - Online
Resource latest information.
24. Describe distribution activities which affect the
quality of the active substances
◦ Maintenance of the premises & Pest control
◦ Recording of the storage conditions
◦ Security of stocks on site & of consignments in transit
◦ Withdrawal from saleable stock
◦ Handling of returned product
◦ Recall plans
3/29/2015 24
Drug Regulations - Online
Resource latest information.
25. Procedures
◦ Approved
◦ Signed
◦ Dated
By person responsible for the quality system
3/29/2015 25
Drug Regulations - Online
Resource latest information.
26. Procedures
◦ Use only valid and approved procedures
◦ Review regularly
◦ Keep up to date
◦ Apply version control
◦ Implement document control system
◦ Prevent inadvertent use of the superseded version
◦ Remove superseded or obsolete procedures & archive
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27. Records
◦ Clear
◦ Be made at the time each operation is performed
◦ Significant activities or events are traceable
◦ Retained for at least 1 year after the expiry date
◦ For actives with retest dates for at least 3 years
after the batch is completely distributed
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28. Records that should be retained and be available include:
(i) Identity of supplier, original manufacturer, shipping agent and/or
consignee
(ii) Address of supplier, original manufacturer, shipping agent and/or
consignee
(iii) Purchase orders
(iv) Bills of lading, transportation and distribution records;
(v) Receipt documents
(vi) Name or designation of active substance
(vii) Manufacturer’s batch number
(viii) Certificates of analysis, including those of the original manufacturer;
(ix) Retest or expiry date
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29. Records
◦ Each purchase and sale
◦ Date of purchase or supply
◦ Name of the active substance
◦ Batch number
◦ Quantity received or supplied
◦ Name and address of the supplier
◦ Name & address of the original manufacturer, if not the same
◦ Name & address of the shipping agent and/or the consignee
◦ Ensure traceability of the origin and destination of products
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30. Records
Records that should be retained and be available include:
(i) Identity of supplier, original manufacturer, shipping agent and/or
consignee;
(ii) Address of supplier, original manufacturer, shipping agent and/or
consignee;
(iii) Purchase orders;
(iv) Bills of lading, transportation and distribution records;
(v) Receipt documents;
(vi) Name or designation of active substance;
(vii) Manufacturer’s batch number;
(viii) Certificates of analysis, including those of the original manufacturer;
(ix) Retest or expiry date.
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31. Premises & Equipment
◦ Suitable and adequate
◦ Ensure proper storage & protection from
contamination
Narcotics
Highly sensitising materials
Materials of high pharmacological activity or toxicity
Distribution of active substances.
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32. Premises & Equipment
◦ Suitably secure to prevent unauthorised
access
◦ Installed with monitoring devices to
guarantee the quality attributes
◦ Monitoring devices should be calibrated
◦ Approved & written schedule
◦ Use of certified & traceable standards
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33. Orders
◦ Manufacturer, importer or distributor of
API established in the EU should be
registered according to Article 52a of
Directive 2001/83/EC
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34. Receipt
Reception area
◦ Protect deliveries from prevailing weather
conditions during unloading
◦ Separate from the storage area.
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35. Receipt
Examine deliveries
(i) Containers are not damaged;
(ii) All security seals are present with no sign of tampering;
(iii) Correct labelling, including correlation between the name used
by the supplier and the in-house name, if these are different;
(iv) Necessary information, such as a certificate of analysis, is
available; and
(v) The active substance and the consignment correspond to the
order.
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36. Receipt
◦ Quarantine consignment
Physical
Equivalent Electronic system
◦ Broken seals
◦ Damaged packaging
◦ Suspected of possible contamination
◦ Investigate the cause of the issue
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37. Receipt
◦ Specific storage measures
Narcotics
Products requiring a specific storage
Temperature or humidity
◦ Identify immediately
◦ Store in accordance with written instructions
◦ Follow relevant legislative provisions
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38. Receipt
◦ Falsified A P I
◦ Segregate
Physically or
Using an equivalent electronic system
◦ Inform the national competent authority of
the country in which he is registered.
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39. Receipt
◦ Rejected materials
◦ Identify
◦ Control
◦ Quarantined
Prevent use in manufacturing
Prevent further distribution.
◦ Records of destruction activities should be readily
available.
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40. Storage
◦ Store under conditions specified by the manufacturer
◦ Controlled temperature and humidity when necessary
◦ In a manner to prevent contamination and/or mix up
◦ Monitor storage conditions
◦ Maintain records
◦ Quality responsible should review records
◦ Qualify storage area for specific storage conditions
◦ Operate area within specified limits
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41. Storage Facility / Area
◦ Clean
◦ Free from litter, dust and pests
◦ Implement precautions against
Spillage
Breakage,
Attack by micro-organisms
Cross-contamination.
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42. Storage
◦ Implement stock rotation,
‘first expiry (retest date), first out’,
◦ Check regularly that the system is operating correctly.
◦ Validate electronic warehouse management systems
◦ Separate Active substances beyond their expiry date
from approved stock
Physical separation or use an equivalent electronic
◦ Ensure that this material is not supplied
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43. Contracted Storage & Distribution
◦ Ensure that contractor
Knows his responsibilities
Follows the appropriate storage and transport conditions
◦ Have a written contract
Clearly establish duties of each party.
Do not permit further sub contracting without written
authorisation.
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44. Deliveries to customers
◦ Supplies within the EU
Only by distributors registered according to Article
52a of Directive 2001/83/EC
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45. Deliveries to customers
◦ Transport in accordance with conditions specified by
the manufacturer
◦ Transport should not adversely quality.
◦ Maintain product, batch and container identity at all
times.
◦ All original container labels should remain readable.
◦ Implement a system for identification & recall
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46. Transfer of Information
◦ Notification to customers
Any adverse information or event
Potential to cause an interruption to supply
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47. Transfer of Information
◦ Regulatory Information
◦ Product Quality Information
Distributor responsible for transfer
From an active substance manufacturer to the
customer
From the customer to the active substance
manufacturer
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48. Transfer of Information
◦ Distributor to provide information from the manufacturer to
the customer :
Name and address of the original active substance manufacturer
Batch number(s) supplied
Copy of the original certificate of analysis
Identity of manufacturer to competent authorities upon request
Original manufacturer can respond to the competent authority
directly or through its authorised agents
C OA
Refer section 11.4 of Part II of Eudralex Volume 4.
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50. Active substances should only be returned to saleable stock
if:
The active substance is in the original unopened container(s)
and in good condition
It is demonstrated that the active substance have been stored
and handled under proper conditions
The remaining shelf life period is acceptable
They have been examined and assessed by a person authorised
to do so
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51. Maintain records of returns.
Include following details in the records:
Name and address of the consignee
Active substance batch number and quantity
returned
Reason for return
Use or disposal of the returned active substance
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52. This assessment should take into account
The nature of the active substance
Any special storage conditions it requires
The time elapsed since it was supplied.
Give special attention to products requiring special
storage conditions.
Seek advice from the manufacturer of the active
substance.
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53. Release to active stock
◦ Only by appropriately trained and authorised
personnel
◦ Place such that the 'first expiry (re-test date)
first out' system operates effectively
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54. Complaints
◦ May be received orally or in writing
◦ Record all complaints
◦ Investigate according to a written procedure
◦ Review Quality Complaint with manufacturer
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55. Complaints
◦ Determine need for further action
With other customers
With the competent authority
Or both.
◦ Conduct Investigation
◦ Document investigation
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56. Complaint records should include:
◦ Name and address of complainant
◦ Name (and, where appropriate, title) and phone number of person submitting
the complaint
◦ Complaint nature (including name and batch number of the active substance)
◦ Date the complaint is received
◦ Action initially taken (including dates and identity of person taking the action)
◦ Any follow-up action taken
◦ Response provided to the originator of complaint (including date response sent)
◦ Final decision on active substance batch or lot
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57. Retain records of complaints
Take appropriate corrective action
Evaluate
◦ Trends
◦ Product related frequencies
◦ Severity
Make these records available to competent
authorities
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58. Responsibility of Original
Manufacturer
◦ Distributor may refer to Original Manufacture
◦ Distributor record should include Manufacturer
response
◦ Record the date and information provided by
original manufactuer
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59. Serious or Potentially life-threatening
situation
Inform
◦ Local authorities
◦ National authorities
◦ International authorities
◦ Obtain their advice
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60. Recall
◦ Designate a person to handle recalls
◦ Written procedure
◦ Define circumstances for recall
◦ Define
Person to evaluate information
How to initiate a recall
Whom to inform about recall
How to treat recalled material
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61. Conduct & Record Self Inspections
Self Inspections should monitor the
implementation of and compliance with this
guideline.
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62. This presentation was compiled from freely
available resources like the website of EU , EMA ,
specifically “Guidelines on principles of Good
Distribution Practice of active substances for
medicinal products for human use”
“Drug Regulations” is a non profit organization
which provides free online resource to the
Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of Pharmaceuticals.
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