Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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Dr Archana Dambal

"Journal of clinical and diagnostic research is a welcome change in publishing practices. It aims to reach out to the grass-root level researchers who do not lack in experience, clinical material and ideas, but lack in their knowledge in English language and statistics. The journal achieves it's aim by supporting in these exact domains.
It also gives due credit to all research designs like descriptive and qualitative studies while many journals ignore these important study designs. The rigorous review process does not allow any compromise in quality
It is indexed in many indexing agencies and the articles are available under creative commons licence free of cost
The frequency of publication supports many aspiring authors from India and other countries.
It's wide scope welcomes articles across various specialities in medicine. In an era when there is an unscientific insistence on speciality specific research by regulatory bodies in medical education, JCDR supports collaborative research across specialities. I wish the publisher all the best in his future endeavors."



Dr. Archana Dambal
Department of General Medicine,
Belgaum Institute of Medical Sciences,Belgaum, Karnataka,INDIA,
On 30 Nov 2018




Dr Bhanu K Bhakhri

"The Journal of Clinical and Diagnostic Research (JCDR) has been in operation since almost a decade. It has contributed a huge number of peer reviewed articles, across a spectrum of medical disciplines, to the medical literature.
Its wide based indexing and open access publications attracts many authors as well as readers
For authors, the manuscripts can be uploaded online through an easily navigable portal, on other hand, reviewers appreciate the systematic handling of all manuscripts. The way JCDR has emerged as an effective medium for publishing wide array of observations in Indian context, I wish the editorial team success in their endeavour"



Dr Bhanu K Bhakhri
Faculty, Pediatric Medicine
Super Speciality Paediatric Hospital and Post Graduate Teaching Institute, Noida
On Sep 2018




Dr Mohan Z Mani

"Thank you very much for having published my article in record time.I would like to compliment you and your entire staff for your promptness, courtesy, and willingness to be customer friendly, which is quite unusual.I was given your reference by a colleague in pathology,and was able to directly phone your editorial office for clarifications.I would particularly like to thank the publication managers and the Assistant Editor who were following up my article. I would also like to thank you for adjusting the money I paid initially into payment for my modified article,and refunding the balance.
I wish all success to your journal and look forward to sending you any suitable similar article in future"



Dr Mohan Z Mani,
Professor & Head,
Department of Dematolgy,
Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



Dr Kalyani R
Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
‘Knowledge is treasure of a wise man.’ The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
As an experienced dentist and an academician, I proudly recommend this journal to the dental fraternity as a good quality open access platform for rapid communication of their cutting-edge research progress and discovery.
I wish JCDR a great success and I hope that journal will soar higher with the passing time."



Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011

Important Notice

Reviews
Year : 2009 | Month : June | Volume : 3 | Issue : 3 | Page : 1591 - 1595

Change Control System In The Pharmaceutical Industry In The Lean Thinking Concept

FERNANDES F*, PANDE S**, MURTY P N***

* M. Pharm, (PhD) Pharmacy, Bherampur University, **Senior Vice President, Corporate Quality Assurance, Glenmark Pharmaceutical Limited, Mumbai, ***Principal and Professor of Pharmacy, Royal College of Pharmacy and Health Sciences, Behrampur, (India).

Correspondence Address :
Francis Fernandes E.mail: fransha.ape@gmail.com

How to cite this article :

FERNANDES F, PANDE S, MURTY PN. CHANGE CONTROL SYSTEM IN THE PHARMACEUTICAL INDUSTRY IN THE LEAN THINKING CONCEPT. Journal of Clinical and Diagnostic Research [serial online] 2009 June [cited: 2019 Aug 26 ]; 3:1591-1595. Available from
http://jcdr.net/back_issues.asp?issn=0973-709x&year=2009&month=June&volume=3&issue=3&page=1591-1595&id=516

Change control is one of the critical elements in a pharmaceutical or biotech company's quality management system. Inadequate change control procedures end up creating a huge risk of non-compliance. The change initiatives are aimed at improving quality, increasing yield, reducing costs, cutting waste, streamlining processes etc. It would be very difficult to carefully manage and expedite change control in a large company or a fast growing organization without a six sigma or Lean thinking concept.

The challenge that Quality Assurance Managers are facing today, is on how to keep pace with rapidly changing regulatory needs, and at the same time, to increase output with limited resources. Pharmaceutical Quality systems can earn more profit from learning to think in terms of Lean, a philosophy that aims to eliminate waste. Based on a customer-focused view, six steps can provide a strong foundation for any organization that wants to incorporate Lean into its operating philosophy. These steps in Lean thinking can be best evaluated at the producer end by Authenticating and reviewing each step, one at a time.

1. Value
2. Value Stream
3. Flow
4. Pull
5. Perfection
6. Replication

Lean thinking can best start by giving due consideration to value, which ultimately is the customer's requirement. The value of any product (goods or services) is defined by customer needs and not by any non-value-added activity at the supplier’s or producer’s end. That is, the customer is prepared to pay for the operations by producers or their suppliers that transforms the product in a way that is meaningful to the customer. Customers do not want to pay for “waste at the producer’s end”.

1. Value (Specifying)
Value is determined by the customers who want to buy the right product with the right quality at the affordable price. That is, the product must be "right" every time – from design to manufacture and from delivery to error-free operation. Lean works on making their processes right by eliminating waste – something no customer wants to pay for.

In Case of Pharmaceutical Products, value defined by the FDA (customer) for drugs is contained in five types of documents utilized by the FDA to ensure that the manufacturer’s products are safe, effective and have the identity and strength to meet the quality and purity characteristics as intended: FD and C, 21 CFR and Federal Register, CPGMs, other manuals, and Human Drug cGMP Notes issued by the FDA. While generally linking the term "value" with the Change control management system in Pharma, in accordance with the FDA documents referenced above and industry standards, the following components are to be reviewed for the value for the customer, as it relates to any specific change.

The Change control system evaluates and approves proposed Minor, Major, and Critical changes to specifications, test procedures, raw materials, facilities, critical systems, support systems, equipment, computer systems (hardware, software), control systems, process steps, packaging materials, and label changes relative to the validations, regulatory submissions, license impact, current written documentation and product quality (identity, strength, purity, potency, safety, efficacy). It also approves the implementation of new equipment and systems, as well as evaluates, approves, and determines the quality release requirements for repairs to facilities, equipment, and systems that could impact product quality.

2. Value Stream Mapping (Identifying)
Once the value is specified by the customers, the next Lean step is to identify the right process – a process that only adds value to the product: in other words, a waste-free process. The value stream for a product has three categories of activities:

a. Process steps that definitely create value: In any manufacturing process, the steps that actually transform the fit, form or function of the raw material, and bring it a step closer to the finished product.

b. Process steps that create Sub value but are necessary due to the current state of the system: In any manufacturing process, activities like inspection, holding and transportation steps.

c. Process steps that create no value and can be eliminated: Any activity that does not fall into the above two categories.

While the parts of a process that create no value should be eliminated, any action or activity that is recognized as non-value-added, but is currently necessary, should be targeted for improvement. At this point, a detailed process flow diagram should be generated for each product or product category. To ascertain as to which steps in the process are unnecessary or can be improved for better productivity, an intense questioning and re-examining method (Japanese term is kaikeku) should be applied to every aspect of the unit process under consideration.

This change control component consists of a value stream and sub-value streams as appropriate for minor, major and Critical changes. There are value streams for repairs, changes or modifications and new introductions of manufacturing equipment, control systems, critical systems, support systems, facilities in the manufacturing area, room classification changes, environmental controls, materials, material inspection requirements, procedures, batch records, forms, software, hardware, manufacturing processes, moving manufacturing processes within the facility, testing specifications, testing methods, drawings, product specifications, product label specifications, packaging specifications, supplier contracts and other systems. The value stream for major change to a manufacturing process using a new piece of major equipment is detailed by the following value added activities:

>> Generate a change request detailing the current situation, proposed change, impacted product and justification for change,
>> Obtain required signatures and submit to the change control
>> Present the proposed change to the Change Control Board (management representatives of regulatory affairs, change control, engineering, environmental health and safety, Head of manufacturing, validations, quality auditing, laboratories, technical support, quality operations, and the Head of quality).

>> Evaluate and identify as required or not required, all of the following items at the change control board meeting:

> Environmental health and safety impact,
> Validation (process, cleaning, equipment, computer systems, facilities, other systems),
> Calibration,
> Computer 21 CFR 11 assessment (electronic records, electronic signatures),
> Material qualification,
> Material evaluation,
> Supplier approval evaluation,
> Global pathogen safety,
> Stability evaluation,
> Document changes
> Regulatory assessment relative to regulatory authority (global) submissions (pre-approval, changes being effective - 0 days, changes being effective – 30 days, annual reportable, medical approval),
> Notification of affected customers (requires notification and approval of marketing)
> Notification of other affected facilities
> Other studies as determined.

>> Determine the acceptance of the proposed change and target the completion date
>> Obtain signatures of all required change control board members
>> Validate equipment, cleaning and re-validate process, verify that no negative impact exists (related equipment, environmental monitoring, any downstream products) and include signed validation packages in the change package
>> Validate the computer system or PLC if required, for equipment operation
>> Generate stability data, probably with accelerated aging stability test results as applicable, for release of the product produced with the new process
>> Generate all required new documentation (procedures and forms for operation of the equipment and training documentation, cross-reference of the new process validation in the existing validation package), procedure revisions (manufacturing run-sheets, etc.), regulatory submissions with approvals as required (i.e. pre-approval) from all applicable countries, associated agencies, customers and other facility notifications, stability requirements, material qualifications, new drawings and updates and include in change package .
>> Generate a post-approval effectiveness assessment plan including predetermined specifications for quality indicators, duration of effectiveness monitoring, and responsible personnel for monitoring
>> Assemble all required information and verify all approval signatures in the change request package and obtain required signatures to set the effective date of change (first potential date of use)
>> Document the implementation date of change (date change was first used in process)
>> Include signed post- implementation approval effectiveness
>> Close and file the change request package.

3. Flow
This Lean step focuses on rapid product flow (RPF). The specific process waste is identified at each stage of the process flow and is eliminated. The team involved in Lean will physically walk the process and write down the distance that the product travels during its process flow. The non-value-added distances are eliminated by physical layout change, which involves both human and machine. Factory floors are laid out in cells rather than in functional groupings, which reduces the distance that the parts travel in the process flow.

It is at this point that the Lean enterprise implements 5S, a tool which is developed for reducing the slack hidden in the manufacturing processes. 5S is the basis for Lean manufacturing and the foundation for a disciplined approach to the clean workplace. The five steps of 5S are (in Japanese and English):

1. Seiri/Sort: Meaning sorting or segregating through the contents of the workplace and removing all unnecessary items.
2. Seiton/Straighten: Meaning putting or arranging the necessary items in their place and providing easy access by clear identification.
3. Seiso/Shine: Meaning cleaning everything, keeping it clean and using cleaning to inspect the workplace and equipment for defects.
4. Seiketsu/Standardize: Meaning creating visual controls and guidelines for keeping the workplace organized, orderly and clean: in other words, maintaining the seiso, or shine.
5. Shitsuke/Sustain: Meaning instituting training and discipline to ensure that everyone follows the 5S standards.

Flow from change control relative to the value stream discussed, means that the validation is completed quickly, thoroughly, and properly. It also means that the required signers are involved, informed, and available (including regulatory affairs), assessments are correct, all required submissions and notifications are completed (regulatory affairs, customers, other facilities, etc), documents are issued, all plans are in place, and that all the required activities are executed concurrently when possible. Many employee frustrations in the value stream (and outside the value stream) result from poor planning, poor organization, inadequate coordination and delay in any or all of the required activities of the sub-value stream. These delays result in the slow implementation of changes or improvements, increased costs, and increases in the potential compliance and business risks.

4. Pull
The benefits of Lean Steps 1, 2 and 3 allow a company to produce more than before and in a way that value is added at every step in the production process. The fourth Lean step can be directed towards either removing excess capacity (inventory) or increasing the rate of pull.
Lean, which identifies the seven wastes, are defects, over-production, transportations, waiting/holding, inventory, motion and processing (or the acronym, DOTWIMP). This lists the inventory as a source of waste. Hence, producing anything that is not sold immediately and is waiting at any point of time for delivery is waste. A pull system, which on the production side is making a product at the same rate at which it is being sold, is a waste-eliminating step. On the supply side, a pull system is flowing resources into a production process by replacing only what has been consumed.

Pull, from the change control perspective, relative to the value stream discussed, would focus on open change requests (inventory) and a supply side pull of required information from all areas contributing to the completion of requirements as identified. Open change requests represent enormous quality and business risks. This inventory represents high compliance risks as well. The introduction of the new equipment and processes that interact with the existing systems and processes are difficult to isolate. There is a potential negative impact to the existing systems and processes, potential that the new equipment and process will be used inadvertently prior to authorization, and potential of the validation personnel contaminating or interfering with the on-going product manufacturing activities. Although the change owner of the change request is responsible for completion of the requirements, change control will frequently have to provide additional follow-up (pull) along with appropriate management to drive the change request to closure. Additionally, the new equipment and processes cannot be implemented until completion of the requirements and acquisition of the required approvals; therefore, the proposed improvements cannot be realized to improve the bottom line.

5. Perfection
This Lean step emphasizes that continuous improvement has to be a part of the organization and is always possible. This is the desired state of any change in any environment. The organization should always try to achieve what is the perfect system for that kind of operation and should aim at continuously improving the present system. The word for this in Japanese is ‘kaizen’.

Perfection in this application would result in all of the FDA required deliverables being closed prior to the end of the physical manufacturing cycle, resulting in the physical manufacturing cycle time being equal to the total product cycle time.

6. Replicate
This Lean step is a confirmation of the system implemented and the improvements achieved that determines that these same systems, procedures, tools and techniques can be deployed anywhere in the operation or in any business process. The key benefit of this step is that any time spent in analysis is reduced.

Now is the time to ask these questions:
• How will the team ensure that the business learns from its experience?
• Can this process improvement be replicated in other parts of the business?
• Is the control set true enough for a similar type of operation?

Hence, finally it can be concluded that each of the processes involved in the quality systems of Pharmaceutical, Biotec or CRO companies has some element of waste. Utilising Lean philosophy, the “wastes” in the complete cycle of the Change control system can be identified and eliminated or improved upon in order to have a better Quality system and overall efficiency with a net result of increased compliance. However, any waste elimination or process improvement proposal should not impact the basic principles of the product’s identity, safety, efficacy, purity or FDA requirements.







References

1.
. Food and Drug Administration homepage. Available: http://www.fda.gov.
2.
. Stratton, S.D. (2004). “The application of lean thinking to pharmaceutical quality systems, defining the FDA as the customer”. California state university, Dominguez hills
3.
. Womack JP and Jones DT (1991). The machine that changed the world. New York: Harper Collins.
4.
. Womack JP and Jones DT (2003). Lean Thinking. New York: Free Press.

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  • Journal seek Database
  • Google
  • Popline (reproductive health literature)
  • www.omnimedicalsearch.com