IDMa-apa pharmaceutical analysts convention (pac) 2018: a Report
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IDMA ACTIVITIES
IDMA-APA Pharmaceutical Analysts Convention
(PAC) 2018: A Report
Indian Drug Manufacturers’ Association (IDMA) and growth of our industry towards world class quality and
along with Association of Pharmaceutical Analysts global compliance”.
(APA) organised the 20 th Pharmaceutical Analysts’
Convention on 18th and 19th May 2018 at The Club, Mr Deepnath Roy Chowdhury, National President,
Mumbai on the theme ‘Best Practices for World Class IDMA delivering the Welcome Address said that “IDMA
Generics’. has always believed in best practices, training and
equipping members to meet regulatory challenges. For
The Convention was well-attended with participation the 3rd consecutive year Department of Pharmaceuticals
of over 200 delegates from more than 60 pharmaceutical and IDMA successfully organised a series of workshops
companies. Delegates included employees and experts & seminars on upgrading Regulatory and Manufacturing
from various disciplines such as Pharma Analysis, Quality Standards for SMEs”. He also said that the role of top
Control, Quality Assurance, Regulatory, Production, management is crucial in setting high aspiration, right
R & D, Academia, Marketing, Media etc., including quality mindsets and providing right resources and
guests and invitees, Past Presidents, IDMA Executive infrastructure. Managements that commit to quality
Committee Members along with IPC Officials, CDSCO excellence reap benefits, often significantly boosting
and NTTL Officials, USP. The event was supported by their production, branding and customer loyalty. He
over 14 companies including Optel India Pvt Ltd., Toshvin said “World Health Organisation’s assessment of Indian
Analytical Pvt Ltd., ACG Associated Capsules Pvt Ltd., National Regulatory Agency and the encouraging result
LGC, Mercury Laboratories Ltd, Manisha Analytical of the survey conducted in India by Ministry of Health
Laboratories, Sotax India, Thermo Fisher Scientific, & Family Welfare regarding NSQs & Spurious Drugs
Thermolab Scientific Equipments Pvt Ltd., (Thermolab are significant developments in India’s march towards
Group) Chromachemie, Autocal Solutions, Anchrom ensuring ‘Best Practices for World Class Generics’”.
Enterprises, DBS Bank & United States Pharmacopoeia Mr J L Sipahimalani, Quality Management & Technical
India Pvt Ltd. Committee, IDMA & APA, spoke on ‘Significance of PAC
- Journey through 20 Years’. Mr S M Mudda, Chairman,
PAC 2018 also witnessed the historic signing Regulatory Affairs Committee, IDMA & APPQM Program
of MOU between Indian Drug Manufacturers’ Director, delivered his presentation on “Leadership for
Association (IDMA) and National Chamber of Quality Excellence”.
Pharmaceutical Manufacturers of Sri Lanka
(NCPM), with IDMA National President Mr Deepnath Chief Guest Dr S Eswara Reddy, Drugs Controller
Roy Chowdhury and President of NCPM Dr Lohita General of India, Special Guest of Honour, Dr Madhur
Samarawickrema signing the MOU. National Gupta, Technical Officer-Pharmaceuticals, WHO India
Anthems of India and Sri Lanka were played before Country Office and Keynote Speaker Dr Ranjit Shahani,
signing of the MOU. Chairman Emeritus, OPPI, Former VC & MD, Novartis
India Ltd. were formally introduced to the congregation
PAC 2018 commenced with ceremonious lighting by Mr Daara Patel.
of lamp by the dignitaries. The inaugural session was
facilitated by Mr Daara B Patel, Secretary General, IDMA. Chief Guest - Dr S Eswara Reddy, DCG(I) in his
He said that “The Pharmaceutical Analysts’ Convention address said that the theme of the Convention “Best
2018 marks 2 decades of our continuous efforts to bring Practices For World Class Generics” was well
analysts, industry heads, regulatory chief and academia considered from the industry point of view. However,
from all over India and overseas together on one platform as a Regulator, he recognised and abided by Drugs &
to discuss and work out strategies for the development, Cosmetics Act and Rules only which does not define
IDMA Bulletin XLIX (21) 01 to 07 June 2018 9
or recognise the word ‘Generic’. As far as he was 20th IDMA-APA PAC 2018
concerned, a drug is a drug should have qualities
IDMA APA Young Pharmaceutical
of stability, safety and efficacy whether generic or Analyst Award 2018
patented and should also be affordable for the patients.
He started his career as a Drug inspector in CDSCO The Indian Drug Manufacturers’
West Zone and he learnt a lot under his mentor the late Association and Association of
Dr M Venkateswarlu. He was happy to participate Pharmaceutical Analysts take
in PAC after a gap of 10 years. He specially advised immense pleasure in awarding
the young delegates to take full advantage of PAC Dr. Swapnil Chudiwal the
to educate and upgrade their knowledge skills. He Young Pharmaceutical Analyst
said that he was eager to interact with technical and Award 2018 at the Twentieth
regulatory personnel and invited the young delegates to Pharmaceutical Analysts’
communicate their inputs and suggestions on technical Convention for the contribution he
matters and Regulatory issues directly to him on his has made in the field of Pharmaceutical Analysis.
email Id dci@nic.in
Dr Swapnil Chudiwal passed the B.Pharm examination in
Dr Madhur Gupta, Technical Officer-Pharmaceuticals, 2006 from University of Pune and the M.Pharm examination in
WHO India Country Office delivered a presentation Pharmaceutical Technology in 2008 from The M.S.University
on, “Medical Products Reforms and the Innovation of Baroda. He has an excellent academic track record
Landscape in India”. In her address she shared that of securing gold medals during B.Pharm and M.Pharm
the Sustainable Development Goal is to ensure healthy courses. He stood 1st in GATE (Graduate Aptitude Test in
lives and promote well-being for all ages. The main goals Engineering) Entrance exam conducted by IIT Kharagpur in
are to expand access to quality assured medicines and the year 2006 with Percentile of 99.99 and All India Rank
health products and emphasises the promotion of health 1. He did his doctoral research at Wockhardt Research
throughout the life course and universal health coverage. Centre affiliated to Dr. Babasaheb Ambedkar Marathwada
Also to ensure that quality essential medicines and University. He has published his research work in reputed
health products are available in sufficient quantities and national, international journals and conferences.
affordable to the population through functioning regulatory Dr Chudiwal started his career as a Research officer in
and procurement systems. She also discussed about the R & D Department at Sun Pharmaceuticals Industries
the current initiative of WHO India. Dr Gupta mentioned Limited and is currently working at Wockhardt Research
that WHO India office has 1500 employees, the largest Centre as a Manager in Research and Development.
workforce among all WHO offices globally.
Dr Chudiwal with his ability to gather, analyze, understand
complex data and a strong academic background enabled
Dr Ranjit Shahani, Chairman Emeritus, OPPI,
Former VC & MD, Novartis India Ltd. in his keynote him to have an excellent hand on pharmaceutical analysis
address spoke on the ‘Future of Healthcare’ and how and validation.
Big forces are shaping the world of business today and In recognition of his achievements and the promising
its impact on healthcare. He highlighted the possibilities future of his ever-growing career we take great pleasure in
of innovation and the trends that shape our future, conferring on him this citation and the prestigious “Young
especially what it would mean for India. He pointed Pharmaceutical Analyst Award 2018”.
out how disruptive technologies have been shaping
our present and how it will impact our future. Globally,
adoption of new technologies is also accelerating and
what was considered almost impossible is today taken Mumbai Deepnath Roy Chowdhury
18th May 2018 National President, IDMA
as a given. Healthcare industry will be greatly affected
and technologies and innovations in healthcare and
pharmaceutical therapies will determine today’s
IDMA Bulletin XLIX (21) 01 to 07 June 2018 10
‘pyramid-shaped’ population profile to make it more
20th IDMA-APA PAC 2018
urn-shaped with people having longer lifespans. It
will be our responsibility to keep the aging population “IDMA-APA PAC Prof. Dr R. T. Sane
Outstanding Pharmaceutical Analysts
healthy.
Award 2018”.
Various technical presentations, panel discussions The Indian Drug Manufacturers’
and break-out sessions were held over the 2 days of the Association and Association of
Convention. Dr Milind Joshi and Ms Meena Shah very ably Pharmaceutical Analysts take
facilitated and moderated the Convention. immense pleasure in awarding
Dr Mrunal A Jaywant the
Release of the PAC 2018 Souvenir, Technical Prof Dr R T Sane-Outstanding
Monograph and Presentation of Awards: Pharmaceutical Analyst Award 2018
at the Twentieth Pharmaceutical
The Chief Guest accompanied by other dignitaries Analysts’ Convention for the great
on the dais released the 20th IDMA-APA-PAC 2018 contribution she has made in the field
of Pharmaceutical Analysis & Regulatory Affairs.
Souvenir and the Technical Monograph “IDMA – APA
GUIDELINE on DATA INTEGRITY GOVERNANCE”. Dr Mrunal Jaywant has obtained her Doctorate degree
from Ruia College, Mumbai under the guidence of Late
The Convention then proceeded with the Award Section.
(Prof.) R. T. Sane in 1997. Dr Jaywant has over 21 years of
The ‘ IDMA APA Young Pharmaceutical Analyst
experience in Research & Development, Analytical Devel-
Award 2018’ was awarded to Dr Swapnil Chudiwal,
opment Laboratory Operations with Documentation in the
Wokhardt Research Centre and the ‘IDMA-APA PAC Prof Pharmaceutical / Healthcare Industry.
Dr R T Sane Outstanding Pharmaceutical Analyst
Dr Mrunal started her career as Executive Analytical
Award 2018’ was presented to Dr Mrunal Jaywant, USP Development in Laboratories Griffon. Thereafter she moved to
India Pvt Ltd for their continued contribution to quality Watson Pharma India Pvt. Ltd. She worked in Cipla Limited,
excellence and future potential in pharma industry. Bangaluru, Unichem Laboratories Limited and Perrigo API
India Limited in API R&D department, as Head AR&D and
Awards were also given to Organising Committee, for AMV Laboratories. She is currently serving United States
their valuable Contribution. Pharmacopeia India Private Limited as Senior Director – R&D
in Chemical Medicines since last 2.5 years. She is Lead
Technical Sessions: Scientific Liaison team at USP India.
Dr. Mrunal has expertise in Laboratory operations,
The Technical Session was facilitated by Dr Milind
Process/Product Development, Quality & Environmental
Joshi, President, Global Regulatory Management, J B
Control and Documentation. She has also Expertise of
Chemicals & Pharmaceuticals Pvt Ltd and Ms Meena
working in Multiple Analytical Fields from API, Formulations,
Kashyap Shah, Consultant, Regulatory Affairs. The Natural Products and their Formulations. She has participated
following presentations were made by eminent speakers/ in number of scientific advice meetings to discuss strategies
faculty members during PAC 2018. for different analytical specification for Raw materials,
Intermediates and Final APIs.
Dr Anandi Krishnan, Consultant, SIDVIM Lifesciences In recognition of her excellent achievements, we take
Pvt Ltd., delivered a presentation on, “Best practice in great pleasure in conferring on her this citation and the
Pharmaceutical Formulation development”. She prestigious "Prof Dr R T Sane Outstanding Pharmaceutical
explained why Affordable medicines are the need of the Analyst Award 2018”.
hour across the globe. She informed the audience that
The Indian government has been introducing various
reforms to make medicines available to the needy - and Mumbai Deepnath Roy Chowdhury
18th May 2018 National President, IDMA
generic medicines contribute largely in making this
effort a success. She discussed about the deficiency in
Award Supported By
establishing appropriate CQAs, CMA CPP, DOE and
IDMA Bulletin XLIX (21) 01 to 07 June 2018 11
identifying and controlling the impurities. She also said product life cycle in detail through his power point
that in-house dissolution methods need more work. presentation and interaction with the audience. He
discussed why risks are high in Pharmaceutical Products
Dr Aniruddha Vaidya, Director, Analytical Solutions, Manufacturing and Controls. He also discussed the role of
delivered a presentation on, “Best practice in Analytical Analytical Laboratory in ICH Q8, Q9 and Q10 environment
development”. He explained why it is important to control and Regulatory application of ICH Q9 and what are the
stages during product development to design a quality future benefits of it.
product and its manufacturing process to consistently
deliver the intended performance of the product. He Dr P L Sahu, Principal Scientific Officer, R & D
also discussed the main factors related to composition Head, IPC India presented, “Key Highlights of Indian
and method of manufacture for tablets, factors related Pharmacopoeia 2018“. He discussed Development
of IP Reference Standards (IPRS), Development of
to physicochemical properties of the drug substance,
Impurity Standards, the monograph development and
factors related to composition and method of manufacture
process of IP 2018 development. He also discussed
for capsules and miscellaneous factors which helps in
about Salient Features, General Chapters, FDC
analytical development of drug product.
Monographs, Monographs (which are not available in other
Ms Sireesha Yadlapalli, Sr Director, Strategic Pharmacopoeia) and D&C Rules – Schedule M: Product
Containers and Closures.
Marketing and External Affairs, USP India (P) Ltd
delivered a presentation on, “Building a culture of
Dr P Radhakrishnanand, Director, Compendial
quality through training”. She discussed about the fresh Development Laboratory - USP spoke on, “Meeting
graduate programmes launched by the USP India Pvt Ltd Elemental Impurities USP Requirement –
at Hyderabad. Implementation”. He discussed about the USP General
Chapter Background and issues, USP General Chapter on
Mr Mayilvahanan Vijayaraghavan, Sr. Manager,
Elements and Limits, Harmonization and Implementation
External Supply Quality, GSK, spoke on, “Current
Plans. He also discussed USP General Chapter on
practices in Aseptic Manufacturing”. He discussed Procedures, Risk Assessment and FDA draft guidance.
about the current aseptic practices used in manufacturing.
He also discussed how the Assurance of Sterility is Dr Mangal Nagarsenkar, Professor (Adj.), Bombay
achieved through good design, operation and maintenance College of Pharmacy delivered a presentation on,
of facilities and equipment. Media fills, environmental “Bridging in vivo and in vitro Testing”. She discussed
monitoring data etc., are there to support a well-designed on in vitro dissolution/ drug release test which plays
and operated facility. an important role throughout pharmaceutical product
development, registration, commercialization and beyond.
Mr Sasidharan Menon, Subject Matter Expert She emphasizes that in vitro dissolution test is an important
(SME) - Design & Evaluation Controlled Environments quality control test which monitors the rate and extent
for Contamination Control delivered a presentation of in vitro drug release. Bridging in vivo bioavailability/
on, “Evaluation Techniques for Containments”. He absorption and in vitro dissolution/release test requires
discussed about the basic fundamentals of Pharmaceutical adding dimensions of ‘biorelevance’ and ‘bioprediction’
isolators, applications, types, design, construction, access to the in vitro test. Probability of correlation of in vitro
& transfer devices, controls and monitoring in detail. He dissolution test with in vivo bioavailability increases with
also discussed the Sanitisation of controlled workspace robustness of dosage forms and simulation of in vivo drug
and its method and why different isolation technology release conditions. She also discussed the important
is required and its application to Product protection/ apparatus used for drug release test, factors influencing
Contamination control. drug dissolution/release and factors to be considered for
meaningful correlation with in vivo performance from a
Mr Rahul Gupta, Vice President, Regulatory Affairs, regulatory point of view. She also emphasize upon recent
USV spoke on, “Quality Risk Management across advances in the in vitro testing protocols adorning the
Product Life Cycle”. He discussed about QRM across
(Contd on pg. 21)
IDMA Bulletin XLIX (21) 01 to 07 June 2018 12
20th IDMA-APA PAC 2018
MOU signed between Indian Drug Manufacturers’ Association (IDMA) and National Chamber of Pharmaceutical Manufacturers of Sri Lanka (NCPM), with IDMA National President
Mr Deepnath Roy Chowdhury accompanied by Secretary General Mr Daara B Patel, and President of NCPM Dr Lohita Samarawickrema on 18th May 2018 at the inauguration
of 20th IDMA-APA PAC 2018 at The Club, Mumbai.
Mr Daara B Patel, Secretary-General, IDMA facilitating Mr Deepnath Roy Chowdhury, National President, Mr J L Sipahimalani, Quality Management & Technical
the inaugural session IDMA delivering the welcome address Committee, IDMA & APA addressing the participants
Mr S M Mudda, Chairman, Regulatory Affairs Committee, IDMA & APPQM Program Dr Madhur Gupta, Technical Officer-Pharmaceuticals, WHO India Country Office making
Director delivering his address her presentation
IDMA Bulletin XLIX (21) 01 to 07 June 2018 13
20th IDMA-APA PAC 2018
Dr Madhur Gupta being felicitated by Mr Deepnath Roy Chowdhury accompanied by Chief Guest Dr S Eswara Reddy delivering his address
Dr S Eswara Reddy
Dr S Eswara Reddy being felicitated by Mr Deepnath Roy Chowdhury Dr Ranjit Shahani, Chairman Emeritus, Dr Ranjit Shahani being felicitated by Mr Deepnath Roy
accompanied by Dr Dinesh Patel OPPI,Former VC & MD, Novartis India Chowdhury
Ltd delivering the Keynote Address
20th IDMA APA PAC 2018 Souvenir released Technical Monograph (Sr.No.7) IDMA-APA GUIDELINE
on “DATA INTEGRITY GOVERNANCE” released
IDMA Bulletin XLIX (21) 01 to 07 June 2018 14
20th IDMA-APA PAC 2018
Dr Mrunal Jaywant, Senior Director – R&D in Chemical Medicines, USP India Pvt Ltd Dr Swapnil Chudiwal, Manager R & D, Wockhardt Research Centre receiving the
receiving "IDMA-APA PAC Prof Dr R T Sane Outstanding Pharmaceutical Analyst "IDMA-APA PAC Young Pharmaceutical Analyst Award 2018"
Award 2018"
Dr Milind Joshi facilitating the Technical Session Ms Meena Shah facilitating the Technical Session
Dr Anandi Krishnan, Consultant, SIDVIM Lifesciences Pvt Ltd making her Audience view
presentation
IDMA Bulletin XLIX (21) 01 to 07 June 2018 15
20th IDMA-APA PAC 2018
Dr Aniruddha Vaidya, Director, Analytical Solutions making his presentation Ms SireeshaYadlapalli, Sr Director, Strategic Marketing and External Affairs,
USP India (P) Ltd, making her presentation
Mr Mayilvahanan Vijayaraghavan, Sr Manager, External Supply Quality, GSK making Mr Sasidharan Menon, Subject Matter Expert (SME) - Design & Evaluation, Controlled
his presentation Environments for Contamination Control, making his presentation
Mr Narendra Ahuja of Development Bank of Singapore (DBS) being felicitated by Mr Rahul Gupta, Vice President, Regulatory Affairs, USV making his presentation
Mr Daara B Patel accompanied by Mr J L Sipahimalani
IDMA Bulletin XLIX (21) 01 to 07 June 2018 16
20th IDMA-APA PAC 2018
Dr P L Sahu, Principal Scientific Officer, R & D Head, IPC India, making his Dr Mangal Nagarsenkar, Professor (Adj.), Bombay College of Pharmacy, making her
presentation presentation
Dr P Radhakrishnanand, Director, Compendial Development Laboratory - USP making Question & Answer Session
his presentation
Mr Shaunak J Dave, CEO & MD - India, OPTEL Mr Ganesh Shenoy, Manager-Scientific Business Question & Answer Session
Group making his presentation Development, ACG Capsules, making his presentation
IDMA Bulletin XLIX (21) 01 to 07 June 2018 17
20th IDMA-APA PAC 2018
Mr Rohit Mahire, International Business Development Manager – Europe, UK, CIS, ACG Mr S M Mudda, Chairman, Regulatory Affairs Committee, IDMA & APPQM Program
inspections Pvt. Ltd addressing the participants Director addressing the participants
20th IDMA-APA PAC 2018 Organising Committee Members (From L to R) Ms Meena Shah, Dr Gaurav Pathak, Mr Kaushik Desai, Mr R Raghunandanan, Mr J L Sipahimalani,
Dr Prashant Dikshit, Dr Satish Desai and Dr Shailesh Nagarsenkar
Chromachemie Laboratory Private Limited Autocal Solutions Pvt. Ltd.
IDMA Bulletin XLIX (21) 01 to 07 June 2018 1820th IDMA-APA PAC 2018
Anchrom Enterprises (I) Pvt. Ltd Sotax India Pvt. Ltd
Thermo Fisher Scientific India Pvt. Ltd LGC
Optel India Pvt. Ltd. Thermolab Scientific Equipments Pvt Ltd.
IDMA Bulletin XLIX (21) 01 to 07 June 2018 1920th IDMA-APA PAC 2018
Toshvin Analytical Pvt Ltd ACG Associated Capsules Pvt Ltd
USP India Pvt Ltd Manisha Analytical Laboratories Private Limited
Question & Answer Session IDMA Secretariat Staff
IDMA Bulletin XLIX (21) 01 to 07 June 2018 20(Contd from pg. 12)
ambit of correlational success for various dosage forms. Breakout Sessions:
The development of a reliable and robust in vitro release
A very well received and appreciated feature of this
test envisages enhanced probability of a successful in vitro
year’s Convention was Breakout sessions where, the
in vivo correlation and forestalls the path to approvals at
delegates were divided into 4 groups, with a Thought
minimal cost and time.
Leader directing deliberations in each group. Each group
elected a member to take down all the key points from
Mr Shaunak J Dave, CEO & MD - India, OPTEL
the session and create a presentation, which was then
GROUP spoke on, “Leveraging serialization for Supply delivered by a representative delegate on behalf of the
Chain 4.0”. Group. This session was facilitated by:
Mr Ganesh Shenoy, Manager-Scientific Business Breakout Session 1 on “Best Practices in
Development, ACG Capsules and Mr Rohit Mahire, Pharmaceutical Development”: Thought Leader:
International Business Development Manager - European Dr Gaurav Pathak, Moderator: Ms Meena Shah, the Group
Union and CIS Countries – ACG Inspections Pvt Ltd leader Mr Darshan Vira presented the summary.
spoke on “Anti – Counterfeiting Measures“. Mr Ganesh
Shenoy discussed on security solutions for products in Breakout Session 2 on “Best Practices in
capsules, Capsule-level protection (base), Tablet-level Manufacturing Operations”: Thought Leader: Mr
Kaushik Desai, Moderator: Mr Raghunandanan, the
protection (base), Blister & pack level protection and
Group Leader Mr Seetharam Kandarpa presented the
Identification & traceability across the supply chain. In
summary.
continuation Mr Rohit Mahire, discussed about the ACG
initiatives with Applied DNA Sciences, Packaging Levels Breakout Session 3 on “Best Practices in Laboratory”:
& Printing Requirements, Communication with NIC Thought Leader: Shri J L Sipahimalani, Moderator:
DAVA Portal and Post Serialization Drug Supply Chain Dr Prashant Dikshit, the Group Leader Mr Bhimrao Patil
Blueprint. presented the summary.
Mr S M Mudda, Chairman, Regulatory Affairs Breakout Session 4 on “Best Practices in Supply
Committee, IDMA & APPQM Program Director delivered chain”: Thought Leader: Dr Satish Desai, Moderator:
a talk on, “Failure Investigation”. He discussed on Dr Shailesh Nagarsenkar, the Group Leader Ms Pranjali
providing best-in-class failure investigation practices that Phatak presented the summary.
will help to identify the true underlying contributing factors
In his concluding remarks, Secretary General
behind the failures. The presentation highlights the myth Mr Daara B Patel appreciated the presentations made by
behind human error. Human error is not a cause of failure, all the eminent speakers. He thanked the speakers and
but a consequence of an error chain below the surface the participants for their interactions and wholehearted
of the problem. The error chain comprises several other involvement and specially thanked the sponsors and
underlying active and latent errors related to systems supporting companies. He also thanked all members
and procedures and leadership and culture that are real of the Regulatory, Technical & Quality Management
causes behind the failure. The presentation emphasizes Sub-Committees, members of the press, the participants/
on the importance of immediate reporting of failures and delegates for their excellent service and finally the IDMA
visit to GEMBA by the key leadership team (seconds to Secretariat team for putting together the event which lead
report and minutes to reach GMBA) to help find the true to it being a grand success!
root causes by the process of active engagement with
the team. In conclusion, he said “if we fail to find the real In conclusion, he announced that IDMA-APA
cause behind the cause reported, we will fail to arrive at 21 st Pharmaceutical Analysts’ Convention (PAC)
a true preventive action and thus miss an opportunity of 2019 will be held in April 2019 which was met with a loud
applause and gusto by all the participants, exhibitors and
providing benefit of continual improvement to the patients,
organisers.
employees and the organization”.
l l l
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