A Regulatory Perspective Presented By Ashok Kumar Dua Plant Head Unichem Laboratories Sikkim GMP Good Manufacturing Practices Till yesterday everything was fine ID: 492904
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Slide1
Good Manufacturing Practices – A Regulatory Perspective
Presented By:
Ashok Kumar Dua
Plant Head –
Unichem
Laboratories
(Sikkim )Slide2
GMP – Good Manufacturing Practices.
Till yesterday everything was fine !!
But suddenly there is a problem in understanding of GMP in Indian Pharmaceutical Industry.
Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )
Gmp – a regulatory Perspective Slide3
What has gone wrong ?
Are we not able to understand
the concept of GMP now ? Something is really serious ?
Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )
Gmp – a regulatory Perspective Slide4
Why it is happening ?
The main reason is changed scenario of the industry
Increased expectation from the Regulatory bodiesAshok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )
Gmp
– a regulatory Perspective Slide5
Why it is happening ?
Increased regulatory oversight in the past year or two has forced quality, regulatory, and compliance personnel to be on their toes. One way that's a good thing in terms of ensuring Quality and, ultimately, protecting patients and end-users. However, it's not without its
headaches - particularly when facing an increasingly demanding & inconsistent inspection environment.
Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )Gmp – a regulatory Perspective Slide6
What we need to do now ?
The key to inspection preparedness, however, is to cultivate a culture of quality within an organization rather than a culture of compliance We need to understand that a culture of quality is characterized by the mindset, "this is how our organization operates on a day-to-day basis under
the confines of our quality management system," rather than approaching every day as if, "we're just trying to get ready for the next inspection."
Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )Gmp – a regulatory Perspective Slide7
What we need to do now ?
Beyond
building a culture of quality, industry can more nimbly navigate the somewhat-volatile inspection process by being aware of patterns and trends that have emerged in recent months as part of increased oversight
Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )
Gmp – a regulatory Perspective Slide8
What are the emerging Trends ?
Variation in investigator experience Heightened scrutiny of purchasing controls Elevated expectation of thoroughness and supporting documentation Increased emphasis on timeliness of responses and investigations Emerging focus on product in commercial distribution
Mounting emphasis on management awarenessAshok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )
Gmp – a regulatory Perspective Slide9
What is the Trend in GMP Compliance ? Increasing Number of Inspections Increasing numbers of Warning Letters
Increasing Enforcement Penalties Increasing Harmonization between Regulatory Agencies
Increasing use of Science & Technology Increasing use of subject matter expertAshok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )Gmp – a
regulatory
Perspective Slide10
What is the Top issue for Compliance ? The top issue in the Warning Letters is the non- GMP compliant handling of electronic data or missing data integrity 8 warning letters contains the following comment
in the same wording :
Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )Gmp – a regulatory
Perspective Slide11
What is the Top issue for Compliance ? The top issue in the Warning Letters is the non- GMP compliant handling of electronic data or missing data integrity 8 warning letters contains the following comment
in the same wording :
Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )Gmp – a regulatory
Perspective Slide12
What is the Top issue for Compliance ? "Failure to prevent unauthorized access or changes to data
and to provide adequate controls to prevent omission of data." "Failure of your quality unit to ensure that materials are appropriately
tested and the results are reported.“ "Failure to adequately investigate complaints and extend the investigations to other batches that may have been affected." "Failure to have appropriate controls for issuance of batch records" "Failure to have appropriate documentation and record controls.” "Failure to record activities at the time they are performed and destruction of original records.”
Gmp – a
regulatory
Perspective Slide13
What is the Top issue for Compliance ? This selection of examples shows the lack of fundamental GMP principles which leads to a blatant misconduct of staff and ultimately to quality defects in the final product.
The main responsibility usually has the quality unit, which task it actually would be to ensure a thorough
training in production and quality control and to monitor compliance with the appropriate regulations. Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )Gmp – a
regulatory
Perspective Slide14
What is the Top issue for Compliance ? These examples of non-GMP-compliant behavior are not limited to active ingredient manufacturers; there are very similar
findings in Warning Letters issued to medicinal product manufacturers.
Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )Gmp – a
regulatory
Perspective Slide15
How do you feel about these trends and the impact on your work and your organization ? What will you do differently in your work as a result of knowing this trend ?
Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )
Gmp – a regulatory Perspective Slide16
What can be achieved by using trends ? Knowledge of GMP Trends can be used for developing , leading , managing and building GMP compliant work ethics and organizational culture for Quality.
Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )
Gmp – a regulatory Perspective Slide17
What can be achieved by using trends ? Knowledge of GMP compliance trends can be useful in pharmaceutical sectors to guide daily work , lead and manage operational control and to develop and execute strategic planning.
Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )
Gmp – a regulatory Perspective Slide18
What is your Perspective ? What is your opinion on 3-5 leading trends in GMP Compliance for Pharmaceuticals What is the value to you in knowing the regulatory compliance trends ? How can a small to medium scale company best use knowledge of the current trends ?
Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )
Gmp – a regulatory Perspective Slide19
What is the Global Perspective ? “ To learn and become better prepared for future inspections”. “ To hopefully prevent serious problems later on that would put us , or our customers at risk including the regulatory agencies that regulate us.” What are we doing to prevent this citation from being ours
Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )
Gmp – a regulatory Perspective Slide20
What is the Global Perspective ? “ To learn and become better prepared for future inspections”. “ Put companies on alert to strengthen their SOPs – the way they are written and the way they are used to train personnel”.
Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )
Gmp – a regulatory Perspective Slide21
THANKS
FOR LISTENING !!Ashok Kumar Dua – Plant Head Unichem Laboratories ( SIKKIM )
Gmp
– a regulatory Perspective