IDMa-apa pharmaceutical analysts convention (pac) 2018: a Report

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IDMa-apa pharmaceutical analysts convention (pac) 2018: a Report
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
IDMa-apa pharmaceutical analysts convention (pac) 2018: a Report
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
IDMa-apa pharmaceutical analysts convention (pac) 2018: a Report
‘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
IDMa-apa pharmaceutical analysts convention (pac) 2018: a Report
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
IDMa-apa pharmaceutical analysts convention (pac) 2018: a Report
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
IDMa-apa pharmaceutical analysts convention (pac) 2018: a Report
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
IDMa-apa pharmaceutical analysts convention (pac) 2018: a Report
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
IDMa-apa pharmaceutical analysts convention (pac) 2018: a Report
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
IDMa-apa pharmaceutical analysts convention (pac) 2018: a Report
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
IDMa-apa pharmaceutical analysts convention (pac) 2018: a Report
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                                                                                                                18
20th 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                                                         19
20th 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

IDMA Bulletin XLIX (21) 01 to 07 June 2018                                                                                 21
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