Capacity building: Can we translate rhetoric into a pharmaceutical infrastructure that will last?

Being a part of the industry, we come across various news articles on industry, and one such article which caught my attention, was titled,“ Beware of ‘Made in India’ medicine”  published in The Hindu Business Line, on August 12, 2015. The author had opined on the current status of the Indian pharmaceutical organizations, while article was not representing the facts completely, it did trigger the curiosity to understand, what are the threats we have as an industry, and what we need to do to mitigate them.

Most of my colleagues, who are either regulators or are working with the industry, are unanimous on one such threat, of supply chain continuity. This sounded a little surprising to me. As the industry exists to provide affordable and quality medicine and regulators are more than happy to allow more players into the market to bring quality medicines into the patient reach. Quality and affordability are a motto for both sides. Patient safety is “the priority” for all, regulators and industry. The number of plants and their capacities are increasing, spending on R&D(1) has increased, and number of people joining the pharma industry has gone multifold. Then where is the threat to “supply chain continuity”.
Apparently most, were worried about, regulatory action, which stems out of deficiency in the quality management system, that makes a site or facility, incapable of supplying medicines into the market, till remediation is completed and is verified by regulatory agency(ies). This process when kicks in takes a lot of effort and time from both the sides, till the process is brought on to the track and the trust is re-established, through all protocols being followed. 

Going deeper, one realizes that this stopping of a site to supply medicines, by a regulatory agency, should not have happened at first place, because, patient safety and quality are the two wheels on which the industry rides. Secondly, no organization would want to deliberately create a situation, which will call for such a harsh regulatory action, one which will prevent them from providing medicines into the market. Regulators on the other hand are working assiduously to safeguard patient interest. They will not be happy to stop supply of a medicine, if they find it to be safe, efficacious and meeting the quality standards. Most of the recent, “import alerts” or “regulatory actions” seen by Indian industry comes from deficient or unsustainable quality management systems.
So why are we finding it difficult to sustain “quality”. One clue is in the attrition rate of employees in the pharmaceutical sector. If one looks at the attrition rate in the pharmaceutical industry, it is 30 to 40 percent at the bottom of the pyramid (2). This bottom consists of people who are at the R&D bench, running experiments, or at shop-floor, manufacturing these medicines, or in the field, selling them. 

While manufacturing plants have increased capacity to produce more drugs, the manufacturing processes are becoming complex, and sourcing of materials to manufacture drugs has gone global. All this and high attrition at shop-floor, has increased pressure on “quality manufacturing”. The organization is stretched at the core to produce drugs, and at the same time is struggling to keep the required positions filled. Thus, we hear a high performing organization, suddenly is in the news for all the wrong reasons. 

Taking its toll on the capability building of the personnel, who are manning operations. The current learning and development departments are still operating under traditional concepts of class room trainings or “read and learn”, collectively called as “apprenticeship model”. This model coupled with high attrition at the bottom, besides the increased complexity of manufacturing operations, is totally out of the sync with the current realities. These classical approaches of capacity building need a lot of time and effort to produce a slow and difficult to evaluate improvements; whereas, the need of the hour is to have a paradigm shift in our technical training methodologies.

Let us take a classical example, where a trainee is trained on a standard operating procedure (SOP). The apprenticeship model of training process which is currently followed in the pharmaceutical industry is described in the following chart:

The success of this SOP training is dependent on following factors:

1.      Complexity/simplicity of the task

2.      Learning ability of the trainee

3.      Resources available to learn  

4.      Availability and time of “trained” personnel

5.      Availability of infrastructure to teach

6.      Time and its quality spent on teaching

This classical apprenticeship (class room training) model, though is rigorous, but on an average takes several weeks to months, for an apprentice to complete the training. The expansion of manufacturing capacity, has led to increased requirement of trained manpower. Ironically, the current trained manpower is stretched not only to complete the increased manufacturing activities, but also is expected to train and qualify new operators and analysts. Over and above a high attrition of these trained operators and analysts has left this model completely ineffective.Therefore the current challenge, that the industry faces, has to rethink and strategize, on how we train and qualify our personnel, to match pace with the growth.

21 CFR 211. 25, USFDA states, “Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions.”   (Highlight is done by author)

The focus of apprenticeship model is on education, training and experience, which are very crucial for sustained quality manufacturing and operations. However no consideration is given on the “assigned functions”. These functions are taken “as is” and no thought is given on rationalizing these functions, with current manpower and their competence.

Rationalization of function:

Delving into history, the answer was discovered by Henry Ford, around a hundred years back, where he quotes, “I have heard it said, in fact, I believe it's quite a current thought, that we have taken skill out of work. We have not. We have put a higher skill into planning, management, and tool building, and the results of that skill are enjoyed by the man who is not skilled." In-line to what Ford said, we cannot reduce the expectation of reaching bigger markets with quality standards and lower costs. In-fact, that will be counter intuitive to innovation and development. We also need to be prepared to face the current challenges and realities, of a people turn-over due to the exploding employment opportunities.

What we need is to invest in:

1.      Designing our processes; for example if we consider explaining this, using a simple process of data collection or documentation, which needs to be designed for manufacturing or testing functions. The key questions, that seek answers are:

a.      Do we have the right people, who understand what critical data is?

b.      Do the people have information on what needs to be collected?

c.       Do they know how it will be collected in real life situations?

d.      Do they know who will collect this data, and what are the realities at the shop-floor?

e.      Do they know why it is important to collect a specific data and what may go wrong?

If we have, a “Yes” as an answer to all the above questions, we have our dream team, which can design the documentation process. If not, we need to invest in capacity building of this team, before launching on any documentation process, which will be handed off to the manufacturing or testing department.

2.      Understanding the functions, we expect people to perform; while drug manufacturing process is designed by Scientists who are better read than the people, who actually manufacture the drug, the information cascade does not always take this difference into consideration. Therefore what appears obvious to many may not be obvious to people, who are at the doing domain. The key questions, that seek answers are:

a.      How is the current man-power (with all its turn-over etc.) going to handle the documentation process, besides being involved with the manufacturing function?

b.      Are the documentation processes easy enough for every doer, (with little or no telling/teaching) to be completing the data collection activity accurately every time?

Remember Ford, when he said“I'm going to democratize the automobile, when I'm through, everybody will be able to afford one, and about everybody will have one." This thought changed the way automobiles were manufactured before Ford(³⁾. Ford inaugurated the era of “mass production” and the car was transformed from a luxury item to a necessity.  What is required in today’s pharmaceutical industry is to do a Henry Ford for our Human resource capability building processes.

3.       Process Management Tools for today and tomorrow: Quoting one of Ford's maxims: "Everything can always be done better than it is being done." The key questions, that seek answers are:

a.      Are our tools (formats, documentation controls) for documentation processes apt for the current requirements and for the foreseeable future?

b.      Have we challenged our documentation processes to fail?

c.       Are there better and simpler tools, which can be applied?

The classical apprenticeship approach focuses on telling operators and analysts about ideal processes (documentation process, as we took the example), which is both cumbersome and perhaps time consuming, while the radical thinking approach focuses on the real life processes and how these processes will integrate in the current infrastructure and in parallel build people capability. This in the experience of the author has provided exponential results.

Today, the Indian pharmaceutical organizations are at the same cross-roads, where Henry Ford was a hundred year ago. The path we choose to tread on today, will take us to the next level, of creating a human infrastructure that will cradle the physical infrastructure for the next hundred years and beyond. Henry Ford’s concepts are testimonial to this.

Contributed by Vishal Sharma

What Today’s Indian Drug manufacturing companies can learn from Antiquity: Lessons from Indian History on “Culture of Quality”

Various places, various platforms, various teams… one discussion, Culture of Quality, or Quality Culture, or was it culture of compliance, or compliance culture, or wait was it good old cGMP…. I am thoroughly confused.

If one searches for “organizational culture” on Wikipedia, this is what appears on the top of the article, “organizational culture encompasses values and behaviors that contribute to the unique social and psychological environment of an organization." According to Needle (2004), organizational culture represents the collective values, beliefs and principles of organizational members and is a product of such factors as history, product, market, technology, and strategy, type of employees, management style, and national culture.”

Quality is one of the fundamental premises on which today’s pharmaceutical industry is operating and excellence is measured with continuous improvement in quality of therapeutic products, supply chain management, testing methods, manufacturing operations etc. Therefore it is pertinent for the pharmaceutical organizations to continuously pursue “culture of quality”. Some of the indicators, which can be utilized for evaluation of organizational culture of quality, are as listed below:

And finally, how does all of this get documented! And how is culture of quality pursued in this documentation?

                                                                                                                       Contributed By

                                                                                                                          Vishal Sharma

TRUST : A NEW AGE BUSINESS PERSPECTIVE

When asked whether he trusts his wife, Adarsh replied with a shrug of indifference, “It depends”. But intent on getting a definitive answer, Som persisted by telling him that it has to be a ‘yes or no’.  To which Adarsh said, “Trust cannot be absolute”.  When asked further as to what he meant, Adarsh elaborated that there are areas where he would trust her and areas where he won’t.   Seeing the perplexed look on Som’s face, Adarsh pre-empted any further queries by hastily adding, “I would trust her as a cook but not as a driver.  So you see, Som, it is not absolute, it’s contextual.  Let’s be practical”

Coming closer to workplace, isn’t that what we need to consider for building trust? Increasing mobility, faster job rotations and increasing competitiveness are redefining our interpretation of trust now.  Culture building has taken a back seat while value-for-money in human asset takes precedence in our haste to meet business objectives.  Under these circumstances, it is common to hear leaders harping on lack of trust, need to build trust and how to build trust.  It is another thing that even Socrates lamented more than 2000 years back that the youth could not be trusted as they are given to vices.  Still, ‘building trust’ is emerging as one of the topmost people’s development needs nowadays.    And, there are a dozen training solutions providers who are offering to help organizations build trust.  But, fundamentally aren’t they missing few key points in a fast paced world that's redefining values: trust is ‘contextual’; not ‘absolute’, trust needs ‘worthiness’; not ‘conferment’,  and trust must be ‘offered’; not ‘demanded’?

Businesses may do well by understanding the nuances of trust building as more and more employees come under pressure to deliver and chase ways to find work-life balance. With employees joining from all walks of life & varied backgrounds and with pressures on containing the attrition rates, how can business leaders go about building an environment of trust which is very ‘business centric’ and effective?  Gone are those days when someone was expected to be trustworthy at all times in all areas.  Today technology has enabled us to ‘police’ people, irrespective of their background, in areas of vigilance and compliance.  So, how do we adapt to the change.  Let’s then focus on the morphed dimensions of trust as they exist today:

Trust is not absolute; treat it skill based:  Trusting people for the skills which matter most for business impact & objectives.  Let’s say, trusting a security supervisor for securing our workplace.
Build expertise to build trust:  Trusting employees for the expertise that they exhibit through their behaviours.  Say, a security supervisor primed to deal with emerging threats better than the criminals inspires trust.

Consistency builds trust:  Integrity & transparency in respective areas of work would work wonders for building trust.   Say, a security supervisor who refuses to accept favours from visitors at all times will build trust in his work domain & elsewhere.

Dependability builds trust:  Acknowledging an experience of dependability with an employee (for the job that he performs) can help build trust.  Say, a security supervisor successfully foiling an intrusion attempt each and every time it happens would help build trust.
                                                                                       Contributed By Mahesh Sharma

You have attended the workshop….how do you retain what you learnt?

I attended recently along with 20 other motivated participants, the HBoS Workshop, conducted by ViennI in Hyderabad. For a non-technical person like me, the dosage of technical, regulatory and scientific input was very high indeed. I struggled to understand and I found myself struggling to retain what I learnt. Got me to think about trying to find a scientific way to retain what I learnt. A bit of reading, browsing and research and I have a XX point formula. And here it is :
1. Use multiple tools - Learn in multiple ways.

• The lecture and the presentations; so my audio and video tools were done. 
• Next was “talk”, so I tried explaining what I  learned to a friend.
• “Writing” ;notes and drawing a mind map. Freemind, a mind mapping tool for free!

2. Teach – Transfer the Learning

• One of the best ways to learn something is to teach it to someone else
•         Teaching solidifies new knowledge in your brain.
•         Share the learning, write a blog. You are all welcome to contribute here on this site !

3. Use Previous Learning - Promote New Learning

• Use relational learning; relate information you have to things that you already know.
• Gather all other relevant information.

4. Practical Experience

• Actually putting new knowledge into practice is the best way to improve learning.
• Perform the activity and use the new knowledge on a regular basis

5. Get a Cheatsheet- Look Up Answers

• Forgotten the details? Go back to the text, the notes or google! 
• You are always better off simply looking up the correct answer
• Or simpler still call us, email us or post a query on this blog!

6. Test yourself

• Taking tests and quizzes actually helps you better remember what you've learned
• It will give you better long-term recall of the materials
• Mail us if you want a quiz !

This is what works for me, do you have any additional tips? Mail us or post your ideas here!

Aseptic Practices and the Myth in the Industry

Manufacturers of sterile pharmaceutical products use aseptic processing for the formulation of liquids, lyophilized products, FFS, Ophthalmic solutions, PFS products etc. Aseptic processes are the preferred route for the manufacture of products that cannot be processed by terminal sterilization.

Aseptic processing systems are constantly evolving. Controlling and maintaining viable and         non-viable particles in the aseptic areas and surrounding environment is a challenge.  There are still multiple grey areas with respect to activities performed during media fills.

A few of the lesser understood aspects are:

•        Hand sanitization : Frequency, methods
•     Changing of gloves : Frequency, methods
•     Conversations/discussions in the areas
•     Sanitization issues
•     Garments/ attire during media fills
•     Sampling during interventions
•     Personnel issues: Qualification, Training
•     Metrics for success and monitoring of the processes
•     Electronic surveillance, Access systems: Dos and Donts

People, their attitudes, knowledge, participation and involvement are key to regulatory success. Regulatory failure is a result of an issue with one of these keys. This is revealed by citations in regulatory warning letters. Regulators usually recommend retraining and re-qualification of the personnel on Aseptic practices and on compliant behavior.

Experts can help in devising and in effective implementation of QMS at sterile manufacturing sites. At Vi’eNnI™ Training and consulting, we are intensively involved in training and development, aimed at improvising, personnel practices, behavior and the attitude towards day today activities. We offer a comprehensive 360⁰solution.

Our workshop “Heartbeats of™ Media fill” in the month of May 2015 in Indore can be a great training/learning experience! 

Training

Education makes a person , but what use of education if it is not put to use. To make that “put to use” one needs to know “how”. Training is a means to achieve the knowhow of HOW!! Today I want to throw light on top 10 reasons why technical, regulatory trainings are best when outsourced to external organizations rather than handled internally

10.  Training Tools – Organizations whose core operations involve training, invest in tools that are real worthy and useful. They  train their trainers in the technical stuff as well as in training and evaluation methodologies. After all a tool cannot replace a human being.

9.  You are good at your “ Core Business” – Any pharma company would consider, training a necessity. Content development, learning systems, management and course delivery are strengths of a dedicated training organization. It is the training organization’s “ Core Business” as much as you excel at your core competencies the training organizer to excel in their core area.

8. Making learning real & relevant -  If your training methodologies, content and structure, delivery mechanisms and processes ought to be real. A lot of case studies, live cases at your site, can be a source of learning.

7. Authentication Requirement – Training helps you successfully navigate through regulatory requirements. Quite often it is necessary to produce training certificates and in some cases essential to prove that you and your team were trained by a trained or certified trainer. When an external training organization does this for you, they will issue certificates backed by experienced trainers, who know what training in all about.

6. Imagine the resources – If you were to plan on handling training ONLY with internal resources, imagine the number of trainers, the levels of knowledge and the time consumed. Training is an intermittent activity that needs FULL dedication for a short period of time. Running the TTT( Train The Trainer) sessions for a select few from your organization can empower some folks to handle training at short notice.

5. Leverage High Level Relationships – Every company has some extra time that can be used to share good practices. It may be a good idea to source the delivery of your training to these people. Sourcing training through partners who can ensure that the best in the business are identified for continued training of your work force, is where a legacy continuity of learning is established.

4. Speed – Getting ready for an audit, for production or for validation or installation may be dependent on getting your team trained right away. Using an external training partner will allow you to get you up and running at a great speed.

3. Wherever – If you have plants in 3 different places in the country and want a uniform, training operation across different sites, then an external partner will ensure that this happens. Internal resources at each of these 3 places will increase the burden on cost and will hamper the consistency of training.

2. Knowledge - No single pharma company has all the knowledge they need internally to be able to train their personnel in every domain. An external partner will either have most of the knowledge or leverage their own resources to ensure that a comprehensive training package is delivered at your site.

1. Cost - The primary reason why companies must outsource training is to save money. It is always about the cost savings and bottomline. In the long run it will be a cost-saver for your company and aid in preventative techniques than in adopting to therapy when diagnosed with chronic illness.

The mantra here stays true. Prevention is better than cure !

On Boarding

     Research and conventional wisdom both suggest that employees get about 90 days to prove themselves in a new job. Every organization has its own version of the complex process through which new hires learn attitudes, knowledge, skills and behaviors required to function effectively.  The bottom line is that the faster new hires feel welcome and prepared for their jobs, the faster they will be able to successfully contribute to the firm’s mission.

     On boarding has four distinct levels, the Four C’s. There are multiple aspects of on-boarding, some that are handled best by the internal teams such as finance, legal and HR and then there are some aspects which are best out-sourced to an outside expert. The aspects that may be out-sourced are highlighted in RED.The four C’s are :

1.       Compliance is the first level of assimilation and this means teaching employees the basics. In a pharma environment the following may be covered.

•        Company’s legal and policy-related rules and regulations

•        Employee code of conduct, work-place ethics

•        GxP, Lab basics, Record keeping, Aseptic handling, Safety (EHS)

•        Regulatory aspects of manufacturing, QA, QC and reporting

2.       Clarification refers to ensuring that employees understand their new jobs and all related expectations

•        KRAs, Assessment, Appraisals

•        Feedback, Coaching, Mentoring

•        Technical expertise, tools ( Sterilization, Aseptic  methods, Statistics)

•        Testing, validation, inspections and instrumentation

3.       Culture is a broad category that includes providing employees with a sense of organizational norms— both formal and informal

•        Company vision, mission, goals

•        Company ethics, culture

•        Culture of Quality

•        Global /Pharmaceutical Industry norms and culture

4.       Connection refers to the vital interpersonal relationships and information networks that new employees must establish

•        High level introductions to leadership

•        Team bonding/building

•        Connections with suppliers, consultants and knowledge keepers

•        Digital connect, web based tools, knowledge bases and forums

   Connect with us at vienni.india@gmail.com or Call on 080-23506862 to evolve complete on-boarding solutions. We have successfully executed multiple collaborative projects with manufacturing, QA, QC and HR  teams across multiple top pharma companies. Together we can create world class teams !

Significance of D-value for establishing hold time for TS-products

Sterilization is key to keeping products, items, articles free of known contamination. One could choose different modes of sterilization such as moist heat, dry heat, ethylene oxide, gamma irradiation, filtration etc. The use of moist heat is the most preferred method in the pharmaceutical manufacturing domains.

Terminal Sterilization (TS) is the process that involves moist heat sterilization of filled and sealed products like vials, ampoules, bottles, bags etc. The sterile hold duration setting for TS products is one of the most critical tasks in the process.  Container size and the fill volume are the key attributes to be considered. A D-value determination (define D-value) helps in the fixing the sterile hold duration of the products. Sufficient care must be built into the design of the experiments to ensure that increase or decrease in the hold time does not affect the quality attributes of the terminally sterilized product.

During the design and development of TS-cycle where the customer had qualified the cycle by coupling a physical and biological approach, evaluating the product attributes post the heat exposure phase depicted an increased impurity level. An investigation of this problem revealed two aspects,

1.      Cycle designed was based on an over-kill approach

2.      D-value used was 2.5 minutes

We brought the VieNnI’s sterilization expertise and experience to the table. Our work and analysis quickly addressed the situation and the solution was framed.

1.      We suggested that an over-kill approach was the least suitable for TS products.

2.      We brought clarity to the process with explanations of the theory and practice of TS.

3.      D-value determination of the TS-product was performed subsequently which was to the customer’s satisfaction.

4.      Regulatory compliance was ensured. Adequate justification, to revise the process including the cycle and validation, development time and cost was made and checked.

We successfully helped the team in meeting quality acceptance criteria of the product and its specifications.

If your sterilization process needs help, if your validation team needs clarity, and if you want your manufacturing operations to be unhindered by these issues, experts from Vienni are just a call away at 91 80 23506562 or email us at vienni.india@gmail.com. Let us design and develop sterilization process and related solutions for you.