USP publishes draft of a new general chapter <661.3> for plastic components used in manufacturing

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May 122016

In the Pharmacopoeial Forum (PF) 42(3) (May-June 2016) the USP General Chapters – Packaging and Distribution Expert Committee proposes a new general chapter <661.3> Plastic Components and Systems Used in Pharmaceutical Manufacturing and a revised version of general chapter <1661> Evaluation of Plastic Packaging and Manufacturing Systems and Their Materials of construction with Respect to Their User Safety Impact. Read more about USPs Proposal on Plastic Components and Systems Used in Pharmaceutical Manufacturing.

<1661> Evaluation of Plastic Packaging and Manufacturing Systems and Their Materials of construction with Respect to Their User Safety Impact. Read more about USPs Proposal on Plastic Components and Systems Used in Pharmaceutical Manufacturing.

see

http://www.gmp-compliance.org/enews_05341_USP-publishes-draft-of-a-new-general-chapter–661.3–for-plastic-components-used-in-manufacturing_15303,15493,Z-PKM_n.html

In the Pharmacopoeial Forum (PF) 42(3) (May-June 2016) the USP General Chapters – Packaging and Distribution Expert Committee proposes a new chapter to address the qualification of plastic components used in the manufacture of APIs (pharmaceutical and biopharmaceutical) and drug products (DPs). The proposed Title of the new chapter <661.3> is Plastic Components and Systems Used in Pharmaceutical Manufacturing. The draft is open for comment until July 31, 2016.

The chapter is part of a suite of chapters, including Plastic Packaging Systems and Their Materials of Construction <661>,Plastic Materials of Construction <661.1>, Plastic Packaging Systems for Pharmaceutical Use <661.2>, and Evaluation of Plastic Packaging and Manufacturing Systems and Their Materials of construction with Respect to Their User Safety Impact<1661>. In addition a section has been added to general chapter <1661> to support the use and understanding of the new general chapter <661.3>. The revision of general chapter <1661> (including change of title) also appears in the PF issue 42(3).

The chapter <661.3> addresses the qualification of plastic components used in pharmaceutical manufacturing and is applicable solely to those processes that involve liquid process streams and process intermediates due to the expected increased degree of interaction with liquids. Plastic manufacturing systems for pharmaceutical use include – for example – bags, cassettes, chromatographic columns, connectors, filling needles, filters, sensors, tanks, tubing, and valves.Elastomeric parts such as diaphragms, gaskets, and O-rings are not in the scope of this chapter. A flow diagram that shows a typical bioprocess DP production suite is shown in general chapter <1661>, Figure 2.

The manufacturer of APIs and DPs is responsible for ensuring that the plastic components and systems used are suited for the intended purpose. It is likely that raw materials, intermediates, process streams, APIs, and DPs will get in contact with one or more plastic component(s) of the manufacturing suite during the manufacturing process, resulting in process-related impurities (PrIs). PrIs have the potential to alter a quality attribute of the DP, if the PrIs persist through the manufacturing process.

Plastic manufacturing components and systems are chemically suited for their intended use with respect to safety if:

they are constructed from well-characterized materials that have been intentionally chosen for use as established by the test methods included in general chapter <661.1>;
The general physicochemical properties of the components have been established;
The biocompatibility (biological reactivity) has been appropriately established;
They have been established as safe by means of the appropriate chemical testing, such as extractables or leachables profiling and toxicological assessment of the test data (“chemical safety assessment”).

The chapter provides guidance on the appropriate application of biological reactivity tests (reference to general chapters <87>, <88>) and physicochemical tests (reference to Food Additive regulations and general chapter <661.1>, where applicable) for manufacturing components and systems. A two-stage approach consisting of an Initial Assessment followed by a Risk assessment leads to the required level of component characterization. The Initial Assessment examines the factors present for demonstration of equivalence with a comparator component or system by looking at the following parameters:

purpose and composition of component or system;
composition of DP(s);
processing conditions;
product dosage form.

The demonstration of equivalence would allow acceptance of the component (or system) without any further characterization. If equivalence cannot be established between the component (or system) under consideration and the comparator, then a Risk Assessment should be conducted. The risk assessment matrix is provided in detail in general chapter <1661>. The outcome of this assessment results in three risk levels: low (A), moderate (B), and high (C). These levels are linked according to the risk of the individual dosage form (e.g. solid oral and liquid oral, others than solid oral and liquid oral) to test requirements as shown in the draft chapter <661.3>. All three risk levels require identification of the component or system as specified in general chapter <661.1>. Identity is only required for those components or systems that consist of single materials of construction (individual polymers only). Biological reactivity testing according to USP general chapter <87> (In Vitro) is required for all levels plus testing according to Class VI in <88> (In Vivo) for Level B and C. Level A and B require that the component or system be tested as specified in general chapter <661.1> for physicochemical characteristics and extractable metals characteristics. Level C components (or systems) must be characterized more rigorously than level A and B components in view of the extractables profile.
Additives: For level A components reference to 21 CFR Indirect Food Additive regulations is sufficient, for level B components additives are determined by testing, and for level C components extraction studies have to be performed.

After free registration in the Pharmarcopoeial Forum you can read the complete drafts of the new general chapter <661.3> and the revised chapter <1661>.

/////USP, draft, new general chapter, <661.3>, plastic components, manufacturing

FDA releases draft guidance on the use of comparability protocols for post approval changes

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Apr 292016

The US FDA released a draft guidance for industry “Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information”. The guidance replaces the draft guidance published in February 2003. It provides recommendations on implementing postapproval changes through the use of comparability protocols (CPs). Read more about FDA´s draft guidance for industry “Comparability Protocols for Human Drugs and Biologics”.

On April 19, 2016, the US Food & Drug Administration (FDA) released a draft guidance for industry “Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information”. Comments and suggestions regarding the draft guideline should be submitted within 60 days of publication.

The guidance replaces the draft guidance published in February 2003. It provides recommendations on implementing postapproval changes through the use of comparability protocols (CPs). A CP is a comprehensive, prospectively written plan for assessing the effect of proposed CMC postapproval changes on the identity, strength, quality, purity, and potency of a drug product or a biological product. Using a CP in an original application or prior approval supplement (PAS) will, in many cases, facilitate the subsequent implementation and reporting of CMC changes. This could result in moving a product into distribution or facilitating a proactive approach to reinforcing the drug supply chain sooner than without a submitted protocol.

The guidance emphasizes that it is intended to establish a framework to promote continuous improvement in the manufacturing of quality products by encouriging applicants to employ tools of ICH Q8 to Q11:

Effective use of knowledge and understanding of the product and manufacturing process;
A robust control strategy;
Risk management activities over a product´s life cycle;
An effective pharmaceutical quality system.

An FDA approved submission containing a CP provides an applicant with an agreed-upon plan to implement the proposed change(s), and in many cases, justification to report the implementation of the proposed change(s) in a reduced reporting category.

FDAs recommendations for the CP content: The CP submission should provide a comprehensive, detailed plan for the implementation of proposed changes and should include the information described below:

Summary;
Description of and Rationale for the Proposed Changes;
Supporting Information and Analysis (based on knowledge and risk assessments, information from development);
Comparability Protocol for the Proposed Change(s) – the CP should describe the specific tests and studies to be performed, including analytical procedures to be used and criteria to be achieved for the expected results. The level of detail that should be provided will depend on the complexity of the change and the specific risks associated with the change to product quality;
Proposed Reduced reporting category (i.e., an annual report, CBE, or CBE-30);
Other Information.

Additionally, the draft guidance provides a “Questions and Answers” section on CPs in the Appendix, which covers general questions and questions regarding formulation, manufacturing site and process, specification (including analytical methods), packaging, and process analytical technology (PAT) changes.

CPs together with “established conditions” may be effective tools for the overall product life cycle management. They can also facilitate the management of post-approval CMC changes in a more predictable and efficient manner, as it is the intention of the planned ICH Q12 Guideline “Lifecycle Management”. Steps 1 and 2 a/b of ICH Q12 are expected for June 2017.

For more information please visit the ICH website and see the FDA draft guidance for industry “Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information“.

///////draft guidance for industry, Comparability Protocols for Human Drugs and Biologics, Chemistry, Manufacturing, Controls Information, fda

Highly potent APIs: can lean manufacturing ever be safe?

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Oct 092014

ALL ABOUT DRUGS

Highly potent APIs: can lean manufacturing ever be safe?

By Fiona Barry +, 09-Oct-2014

The phrase “lean manufacturing” conjures up job cuts and not much more for many people, but managers can use the method to drastically simplify HPAPI (highly potent active pharmaceutical ingredients) production, says an expert.

http://www.in-pharmatechnologist.com/Processing/Highly-potent-APIs-can-lean-manufacturing-ever-be-safe

Green chemistry makes ‘cents’ for cost-focused API firms says expert

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Oct 092014

Green chemistry makes ‘cents’ for cost-focused API firms says expert

By Gareth MacDonald+, 07-Oct-2014

Making drugs generates a huge amount of waste but industry is showing signs of cleaning up its act according to Paul Anastas, the Yale scientist who coined the phrase “green chemistry.”

http://www.in-pharmatechnologist.com/Ingredients/Green-chemistry-makes-cents-for-cost-focused-API-firms-says-expert

Welcome Scientific update to Pune, India 2-3 and 4-5 Dec 2014 for celebrating Process chemistry

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Sep 292014

WEBSITE http://www.scientificupdate.co.uk/

SCIENTIFIC UPDATE HAS A REPUTATION FOR ITS HIGH QUALITY EVENTS, BOTH FOR THE SCIENTIFIC CONTENT AND ALSO FOR THE EFFICIENCY OF ITS ORGANISATION. KEEP YOUR SKILLS UP TO DATE AND INVEST IN YOUR CONTINUING PERSONAL PROFESSIONAL DEVELOPMENT.

TRAINING COURSE 2-3 DEC 2014

Process Development for Low Cost Manufacturing

When:02.12.2014 – 03.12.2014

Tutors:

Where: National Chemical Laboratory – Pune, India

Brochure:View Brochure

DESCRIPTION

Chemical process research and development is recognised as a key function during the commercialisation of a new product particularly in the generic and contract manufacturing arms of the chemical, agrochemical and pharmaceutical industries.

The synthesis and individual processes must be economic, safe and must generate product that meets the necessary quality requirements.

This 2-day course presented by highly experienced process chemists will concentrate on the development and optimisation of efficient processes to target molecules with an emphasis on raw material cost, solvent choice, yield improvement, process efficiency and work up, and waste minimisation.

Process robustness testing and reaction optimisation via stastical methods will also be covered.

A discussion of patent issues and areas where engineering and technology can help reduce operating costs.

The use of engineering and technology solutions to reduce costs will be discussed and throughout the course the emphasis will be on minimising costs and maximising returns.

Conference 4-5 DEC 2014

TITLE . Organic Process Research & Development – India

Subtitle:The 32nd International Conference and Exhibition

When:04.12.2014 – 05.12.2014

Where:National Chemical Laboratory – Pune, India

Brochure:View Brochure

Organic Process Research & Development - India

for

Process Research & Development Chemists
Chemical Engineers in Industry
Heads of Departments & Team Leaders

Benefits

Invest in yourself: keeping up to date on current developments and future trends could mean greater job security.
Learn from a wide range of industrial case studies given by hand-picked industrial speakers.
Take home relevant ideas and information that are directly applicable to your own work with the full proceedings and a CD of the talks.
Save time. Our intensive, commercial-free programme means less time away from work.
Meet and network with the key people in the industry in a relaxed and informal atmosphere.

Do you want to improve efficiency and innovation in your synthetic route design, development and optimisation?

The efficient conversion of a chemical process into a process for manufacture on tonnage scale has always been of importance in the chemical and pharmaceutical industries. However, in the current economic and regulatory climate, it has become increasingly vital and challenging to do so efficiently. Indeed, it has never been so important to keep up to date with the latest developments in this dynamic field.

At this Organic Process Research & Development Conference, you will hear detailed presentations and case studies from top international chemists. The hand-picked programme of speakers has been put together specifically for an industrial audience. They will discuss the latest issues relating to synthetic route design, development and optimisation in the pharmaceutical, fine chemical and allied fields. Unlike other conferences, practically all our speakers are experts from industry, which means the ideas and information you take home will be directly applicable to your own work.

The smaller numbers at our conferences create a more intimate atmosphere. You will enjoy plenty of opportunities to meet and network with speakers and fellow attendees during the reception, sit-down lunches and extended coffee breaks in a relaxed and informal environment. Together, you can explore the different strategies and tactics evolving to meet today’s challenges.

This is held in Pune, close proximity to Mumbai city, very convenient to stay and travel to either in Pune or Mumbai. I feel this should be an opportunity to be grabbed before the conference is full and having no room

Hurry up rush

References

1 http://newdrugapprovals.org/scientificupdate-uk-on-a-roll/

2 http://scientificupdate.co.uk/conferences/conferences-and-workshops.html

3 http://en.wikipedia.org/wiki/Pune

PROFILES

Will Watson

Dr Will Watson gained his PhD in Organic Chemistry from the University of Leeds in 1980. He joined the BP Research Centre at Sunbury-on-Thames and spent five and a half years working as a research chemist on a variety of topics including catalytic dewaxing, residue upgrading, synthesis of novel oxygenates for use as gasoline supplements, surfactants for use as gasoline detergent additives and non-linear optical compounds.

In 1986 he joined Lancaster Synthesis and during the next 7 years he was responsible for laboratory scale production and process research and development to support Lancaster’s catalogue, semi-bulk and custom synthesis businesses.

In 1993 he was appointed to the position of Technical Director, responsible for all Production (Laboratory and Pilot Plant scale), Process Research and Development, Engineering and Quality Control. He helped set up and run the Lancaster Laboratories near Chennai, India and had technical responsibility for the former PCR laboratories at Gainesville, Florida.

He joined Scientific Update as Technical Director in May 2000. He has revised and rewritten the ‘Chemical Development and Scale Up in the Fine Chemical & Pharmaceutical Industries’ course and gives this course regularly around the world. He has been instrumental in setting up and developing new courses such as ‘Interfacing Chemistry with Patents’ and ‘Making and Using Fluoroorganic Molecules’.

He is also involved in an advisory capacity in setting up conferences and in the running of the events. He is active in the consultancy side of the business and sits on the Scientific Advisory Boards of various companies.

………………………………………………………………………………………………….

John Knight

Dr John Knight gained a first class honours degree in chemistry at the University of Southampton, UK. John remained at Southampton to study for his PhD in synthetic methodology utilizing radical cyclisation and dipolar cyloaddition chemistry.

After gaining his PhD, John moved to Columbia University, New York, USA where he worked as a NATO Postdoctoral Fellow with Professor Gilbert Stork. John returned to the UK in 1987 joining Glaxo Group Research (now GSK) as a medicinal chemist, where he remained for 4 years before moving to the process research and development department at Glaxo, where he remained for a further 3½ years.

During his time at Glaxo, John worked on a number of projects and gained considerable plant experience (pilot and manufacturing). In 1994 John moved to Oxford Asymmetry (later changing its name to Evotec and most recently to Aptuit) when it had just 25 staff. John’s major role when first at Oxford Asymmetry was to work with a consultant project manager to design, build and commission a small pilot plant, whilst in parallel developing the chemistry PRD effort at Oxford Asymmetry.

The plant was fully operational within 18 months, operating to a 24h/7d shift pattern. John continued to run the pilot plant for a further 3 years, during which time he had considerable input into the design of a second plant, which was completed and commissioned in 2000. After an 18-month period at a small pharmaceutical company, John returned to Oxford in 2000 (by now called Evotec) to head the PRD department. John remained in this position for 6.5 years, during which time he assisted in its expansion, established a team to perform polymorph and salt screening studies and established and maintained high standards of development expertise across the department.

John has managed the chemical development and transfer of numerous NCE’s into the plant for clients and been involved in process validations. He joined Scientific Update in January 2008 as Scientific Director.

Pune images

From top:1 Fergusson College, 2 Mahatma Gandhi Road, Shaniwarwada 3 the HSBC Global Technology India Headquarters, and the 4National War Memorial Southern Command

NCL PUNE

The National Chemical Laboratory is located in the state of Maharashtra in India. Maharashtra state is the largest contributor to India’s GDP. The National Chemical Laboratory is located in Pune city, and is the cultural capital of Maharashtra. Pune city is second only to Mumbai (the business capital of India) in size and industrial strength. Pune points of interest include: The tourist places in Pune include: Lal Deval Synagogue, Bund Garden, Osho Ashram, Shindyanchi Chhatri and Pataleshwar Cave Temple.

MAKE IN INDIA

http://makeinindia.com/

http://makeinindia.com/sector/pharmaceuticals/

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL

KEYWORDS

JOHN KNIGHT, WILL WATSON, SCIENTIFIC UPDATE, PROCESS, COURSE, CONFERENCE, INDIA, PUNE, PROCESS DEVELOPMENT, LOW COST, MANUFACTURING, SCALEUP

Drug development, approval, manufacturing, and post-marketing…..Japan’s journey of a pharmaceutical product

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Sep 042014

Drug development, approval, manufacturing, and post-marketing

Development of a new drug involves a complicated process that requires a lot of time and enormous amounts of funding. In order to create one drug, you would need to evaluate approximately 700,000 candidates¹⁾. Of them, just one reaches the patients. Here, we will share how a new drug begins its journey, from the research and development of candidate compounds, to a product, to the patients, and how we are involved with drugs once the physician prescribes a drug to patients. We will explain what pharmaceutical companies call “the lifecycle of a drug.”
¹⁾from Japan Pharmaceutical Manufacturers Association DATABOOK 2013

The journey of a pharmaceutical product

1. Basic research

Conduct a research to discover new drug candidate substances and components and create new compounds. Most requires 2 to 3 years. This process also functions as an opportunity to research the yet-to-be-defined mechanisms of diseases, where the basic research conducted may not directly lead to a new drug. Discovering a seed for a new drug is like looking for a piece diamond on the bottom of the deep ocean, where these highly uncertain basic research and drug development research could become the base in identifying several million candidate elements. After this process, a screening method to narrow down potential substances will be developed, and several of the candidate substances move on to the next process.
There are two types of research, collaborative research and sponsored research, where pharmaceutical companies and others provide funding support.
The research is conducted after an official contract is exchanged with universities and others.
Collaborative research：(Joint research expenses in the JPMA Transparency Guideline)

Research institutions such as universities and investigators of pharmaceutical companies and others conduct a research cooperatively.

Sponsored research：(Research commissioning expenses in the JPMA Transparency Guideline)

Sponsors such as pharmaceutical companies entrust research institutions such as universities to conduct the research, where accomplishments are reported to the sponsors.
The journey of a pharmaceutical product

2. Development

1) Non-clinical trial
- CMC: Quality
  CMC stands for Chemistry, Manufacturing and Control. Design and research for manufacturing procedures, specifications and stability tests are carried out.
- A process to investigate the efficacy and safety of candidate drug compounds. An animal testing is conducted for pharmacokinetics, pharmacological and toxicity tests. The next trials are conducted based on data obtained from this first process. This process takes about 3 to 5 years.
- The trial is required to be conducted based on GLP for non-clinical trial regarding safety of pharmaceutical products.
2) Clinical trial
- The clinical trial is conducted by pharmaceutical companies and others based on the Pharmaceutical Affairs Law, in order to have a new drug approved or to apply for a new indication for an existing drug. Other than clinical trials conducted by pharmaceutical companies with an objective of approval application, there are trials called investigator-led clinical trials which are conducted by physicians and medical institutions for the purpose of the approval application.
- The trial process investigates the efficacy and safety of the candidate compound on humans. The clinical trial is conducted mainly in 3 steps, Phase I, Phase II and Phase III. This process takes approximately 3 to 10 years. It is required to conduct the trials based on the GCP.
  
  Phase I trial (human pharmacology study) :
  
  Confirms mainly the compound’s safety among healthy people
  
  Phase II trial (exploratory study) :
  
  Confirms the drug’s administration method and administration amount among a small number of patients
  
  Phase III trial (confirmatory trial) :
  
  Confirms the drug’s efficacy and safety among numerous patients

The journey of a pharmaceutical product

3. NDA and regulatory approval application

The enormous amount of data gathered on candidate compounds so far is compiled into an approval application document and submitted to the regulatory authority in each country/region. In Japan, it is submitted to the Ministry of Health, Labour and Welfare (MHLW). The Pharmaceuticals and Medical Devices Agency (PMDA) will conduct a strict review from a scientific standpoint, and once the efficacy and safety of the candidate compound is confirmed, it will obtain approval by the MHLW as a new drug to be manufactured and distributed.
The PMDA website provides a detailed explanation on the complicated and wide-ranging process from application to approval.

Image result for meiji shrine

The journey of a pharmaceutical product

4. Production, Quality, Information Provision & Product Distribution

1) Manufacturing of newly approved drugs and the quality control process.

In every process of the drug development, from manufacturing to shipping and transportation after shipments, there are strict standards in place, ranging from those defined by the Pharmaceutical Affairs Law, those that require approval from regulatory agencies, and unique standards set within companies.
- Approval and inspection of manufacturing site: Under the Pharmaceutical Affairs Law, a GMP compatibility investigation is required for a new drug to be approved. This is an investigation that also confirms that the manufacturing site has the building, facility and administrative system to constantly manufacture the product which has been guaranteed its efficacy, safety and homogeneity.
  GMP investigation is conducted regularly as well as unscheduled, in addition to the investigation conducted at the time of approval.
- The manufacturing process begins from the measuring of raw materials: (Chugai Pharmaceutical “Manufacturing of active pharmaceutical ingredient/solid drug factory”)
- Decision on shipment: Some products, such as vaccines and blood products, require a national test per lot and may take time for it to be shipped out.
  National test process for vaccines
2) Product distribution and provision of information
- In order to provide new products to hospitals and pharmacies, marketing personnel of pharmaceutical companies develop a supply and distribution plan and work with both internal and external parties to distribute the product. Further, pharmaceutical companies, through their Medical Representatives (MR), work to provide, gather and communicate information and at times disseminate their pharmaceutical products in order to promote the appropriate use of its products.
  Source: MR Education and & Accreditation Center of Japan website
- Information is provided via methods such as scientific seminars, where information is not limited just to its own products but also medical and pharmaceutical papers of disease areas related to the product. Pharmaceutical companies hold briefing sessions together with medical academic conferences, medical institutions and physicians to ensure that scientifically-grounded treatments are promoted. It also provides information to support the physicians’ lifelong learning.
- The works of pharmaceutical companies are not limited to distributing products and providing information to healthcare practitioners, but it also provides information on the disease and about treatments. In order to guarantee the credibility and neutrality of the information, physicians specializing in the field provide support in the manner of writing articles, supervising contents, and participating as lecturers at educational seminars and lectures for general citizens.
- Examples of information provision on the disease and treatments
- The JPMA codes and guidelines
  - Japan Pharmaceutical Manufacturers Association(JPMA) Promotional Code
  - Japan Pharmaceutical Manufacturers Association(JPMA) Transparency Guideline

Image result for golden pavilion kyoto

The journey of a pharmaceutical product

5. Post manufacturing and distribution

Conduct surveys and trials on appropriate use, in order to confirm the new drug’s efficacy and safety in a regular and a daily medical setting that cannot be obtained from a clinical trial conducted for the drug’s approval. For example, through post-manufacturing and distribution clinical trials and post-manufacturing and distribution surveys, collect information on adverse reaction and the drug quality, and communicate assessment and analysis results to medical facilities.
Making changes to items listed in the application material submitted to obtain marketing approval, requires companies to submit an approval application for partial approval and obtain an approval per the Pharmaceutical Affairs Law.
The reporting system of adverse reactions and infectious diseases based on the Pharmaceutical Affairs Law, is for pharmaceutical companies and healthcare practitioners such as physicians and pharmacists to report the MHLW. The objective for this is to appropriately collect adverse reaction, infectious diseases and default information of pharmaceutical products and others in approved medical facilities such as hospitals, and promptly conduct safety measures.
Pharmaceutical companies, in order to promote academic research and provide aid for the research, supports research institutions such as universities, hospitals and medical academic conferences. As an academic research aid, it provides scholarship donations to universities and others. For example, in order to promote case reports that communicate product usage experience by expert physicians for products that have been in the market for 3 to 5 years since post-manufacturing and distribution, pharmaceutical companies will bring together a seminar through donations to the medical academic conferences and co-host seminars with academic conferences. Through such activities, it will promote the products’ safety and appropriate usage post-manufacturing and distribution.
There are also clinical research and clinical trials that are led by physicians and medical facilities conducted after a product’s post-manufacturing. Some physician-led clinical trials do not have an objective to apply for approval, but rather are conducted by physicians and researchers in order to provide the best treatment to patients and promote evidence-based medicine.

……………………………………………………………………………….

The various steps in this process are usually conducted by pharmaceutical companies alone. However, at times accomplishments are made through a cooperative effort with universities and medical institutions. In order for cooperative research with universities and medical institutions to steadily progress, and for new drugs to be created as a result, companies sometimes contribute by providing funding to the research. The types of funding provided are presented in the table below. Also, for certain items an example is illustrated and explained in each process within the “product lifecycle,” and is hyperlinked to the cost items of each member companies’ disclosure target within the JPMA‘s “Transparency guideline for the relationship between corporate activities and medical facilities and others.”
The progress of each process within the “product lifecycle” is managed by adhering to various laws and self-regulations. We will explain the process of drug development that at times is considered complicated, to the manufacturing and distribution of new drugs, and related laws and regulations to adhere to. The following table shows one part of the product lifecycle chart.
Product lifecycle and requirements overview

Terminology: Product lifecycle and related laws

news image

PAL：Pharmaceutical Affairs Law
A Law regulating matters related to the manufacturing, distribution, standards and screening, handling and advertising regulation and others for healthcare products, quasi-drugs, cosmetics and medical devices in Japan. (Law No. 145, Aug. 10, 1960).
GLP：Good Laboratory Practice
A standard for conducting non-clinical studies on the safety of drugs. It is a standard regarding animal studies in non-clinical studies, particularly regulated for toxicity studies.
CMC：Chemistry, Manufacturing and Control
Information regarding Chemistry, Manufacturing and Control. It refers to the integrated concept of researches for drug substance process, drug development, and quality assessment, as well as works related to those researches. The pharmaceutical companies’ CMC includes a wide range of work from non-clinical studies, clinical studies to regulatory approval applications.
GCP：Good Clinical Practice
A standards regarding the implementation of clinical trial for pharmaceutical products.
ICH：International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
A project that brings together regulatory authorities in Europe, Japan and the United States. The purpose is to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration.
GMP：Good Manufacturing Practice
A ministry ordinance related to standards for the manufacturing management and quality management of pharmaceutical products and quasi-drugs. It refers to the standard for the manufacturing management and quality management at manufacturing facilities of pharmaceutical products and others.
PV：Pharmacovigilance
Activities related to the safety monitoring of pharmaceutical products. It refers to the careful monitoring and continuous surveillance of the safety of an approved product during its life on the market.
GQP：Good Quality Practice
A standard on the quality management of pharmaceutical products and others.
GDP：Good Distribution Practice
A standard on pharmaceutical product distribution.
GPSP：Good Post-marketing Study Practice
A standard on the implementation of the pharmaceutical products’ post-marketing surveillance and study.
GVP：Good Vigilance Practice
A standard on the safety management of pharmaceutical products and others after manufacturing and distribution.