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How to Combat the Two Major Deficiencies in Pharma

Yogesh Krishan Davé August 31, 2020 134


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Yogesh Krishan Davé has been working in the pharmaceutical industry for more than 40 years now. He is an EU Qualified Person and a consultant. During this long time, Yogesh has encountered many deficiencies from which most pharma companies suffer.
 
In this podcast, Yogesh has addressed deficiencies in two systems:
1. Training
2. Deviations and CAPA handling
 
And explained how to tackle them!

(YouTube Video Below)

 

Here are some of the things that we can learn about Training Deficiencies in the Pharmaceutical industry.

  1. What are the series of deficiencies that the pharmaceutical company is facing?
  2.  Standard Operating Procedures (What Are They Good For ?)
  3. What are the Management tools to support consistent and objective categories of GMP deficiencies?
  4. How do you motivate yourself in GMP training?
  5. What is the role of the quality department in handling any type of deficiencies?
  6. What are the actions to be taken in response to the reporting of critical and major deficiencies in the pharma industry?
  7. How to Stop Losing Precious Time on Petty Deviations
  8. How to Learn From Other Industries

 

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The Pharmaceutical industry is now experiencing the same phenomenon that many other industries have faced in the past. Many companies were forced to try and reinvent themselves in the face of challenges in their business environment. One of the issues that have been facing the pharma industry is the lack of education and training in pharmaceutical companies.

Standard Operating Procedures (What Are They Good For?)

-Yogesh mentioned how to follow the correct Standard Operating Procedures(SOP) in the pharmaceutical industry. He said that it has different kinds of training systems. This training should be continuous and with sufficient frequency. It should include the topics to be covered, the people to attend, and the approximate timing for each SOP. He mentioned that every person should have a training module and need to understand the SOP. Proper education in GMP training is critical to evaluate the effectiveness of the training. Proper education for this training is a big obligation to be aware of the deficiencies that they will encounter in the future.

What are the Management tools to support consistent and objective categories of GMP deficiencies?

  • When classifying a deficiency as “Critical”, QA should determine if there is clear evidence by considering the risk of harm as in the definition.
  • When a “Critical” deficiency is not evident, the defect may be rated as “Critical”, “Major” or “Other”. A determination on the classification should be made for which the following guidance may be followed:
  • Typically the first steps could include a warning or a re-inspection or reassessment inspection for which failure to address risk with repeat deficiencies may result in a non-compliance or similar rating.

How do you motivate yourself in GMP training?

  • GMP compliance is a priority for many companies, with little room for error. You need to get a deep understanding of Good Manufacturing Practices (GMPs) in the pharma industry. Familiarization is very important and the people who are involved in it. The Quality Assurance department has a big role in motivating people in the production to follow strict quality compliance. Beyond the legal requirement, working knowledge of regulatory requirements is foundational to everything we do. Prioritize all the things that you need during the training. Focus is the key, and understanding each training session is very important.
  • Taking responsibility during the training and the expectations relating to procedures like documentation and data integrity. We also need to learn how to react to deviations or non-conformances in the future. Making general, nebulous statements —like “Everyone is responsible for quality” without providing specific expectations of how that should translate into individual actions.

What is the role of the quality department in handling any type of deficiencies?

  • The Quality Department plays a key role in the design implementation and management of the quality system. For example, management is responsible for establishing the quality system structure appropriate for the specific organization. Management has the ultimate responsibility to provide the leadership needed for the successful functioning of the quality system. All managers should demonstrate visible and robust support for the quality system and ensure its implementation throughout the organization.
  • All managers have the responsibility to communicate workers’ roles, obligations, and authorities within the system to ensure that interactions are defined and understood very well.

What are the actions to be taken in response to the reporting of critical and significant deficiencies in the pharma industry?

Ensure that products are manufactured batch upon the batch, year upon year, to the appropriate and consistent quality standards and in accordance with regulatory requirements by requiring that there be a pharmaceutical quality system.

The risk-based approach in definition and classification of deficiencies

• Deficiencies are descriptions of non-compliance with GMP requirements.

• A distinction is made between deficiencies as a result of –  a defective system or, – failure to comply with the system.

• Deficiencies may be classified as – Critical Observation – potential risk harm to the user – Major Observation – major deviation from GMP/GCP – Minor or Other Observation – a departure from good practice

How to Stop Losing Precious Time on Petty Deviations

  • Even with the best launch plans, there are bumps along the way. There will be issues that are bigger than others, but many problems companies face before launch can be avoided with early planning.
  • For pharma companies, launching a new drug is about more than just a taste of victory—it also means the loss or gain of billions of dollars, and avoiding harm to patients awaiting the arrival of a potential cure.

Here are some general principles to help guide a product team through effective launch planning:

  • Stay focused and bucket activities. Identify critical tasks that are truly essential to the success of your launch, and keep them front and center. Gather activities into two groups: those required to prepare for the launch date, and those that are triggered by approval.
  • Understanding the unique characteristics of both your organization and your product helps determine the launch-preparation strategy.
  • Proper knowledge is very important to prevent losing money and time.
  • With a detailed project plan and the ability to identify risk, firms can exert far greater control over how quickly a new product reaches the market. But what’s most important is how a company responds to the bumps. With skillful risk planning, you can be the early bird every time.

How to Learn From Other Industries

  • Consult from other successful companies like adopting artificial intelligence.
  • Get a consultant that has been in successful companies and get new ideas from them. Inquire if the application to apply. Risk Assessment is very important in handling this matter.
  • Be more adaptive and have a proper risk analysis.
  • Do not afraid to innovate and to capture the huge benefits of improving existing processes for Quality, safety, and productivity. This is how we will reach a new level of Quality beyond compliance with regulations and specifications.
  • There’s abundant information that we can learn from them, like guidelines for evaluation, pharmaceutical development, and exercising the quality stability of a company. Reaching a new level of quality and make sure that the industry competes on Quality beyond Compliance.

 

Information on good manufacturing practices (GMP) in the life science industry is scattered, vague and poorly organized. We have chosen to solve this problem by organizing the best possible GMP webinars and courses to ensure we deliver all the information you need in a concise, engaging and clear format. All events are free and open to anyone in the industry.

Browse Upcoming Free GMP Webinars


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Yogesh Krishan Davé

Yogesh Krishan Davé is a Qualified Person (QP), working in the pharmaceutical industry for about 40 years now. Yogesh has a comprehensive understanding of drug research, drug development, clinical research, and commercial manufacturing. He is also a trained lead auditor in GMP/GDP compliance, and knowledgeable on the ICH GCPs.

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