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Introduction & Purpose
In the last two years, import ban orders have been issued by the USFDA and Canada’s Health Canada to more than 25
Indian API (active pharmaceutical ingredients) and formulations. GMP/ Quality non-compliance could be considered as a
grave threat to trip-up the Indian pharmaceutical industry, growing at a steady trot of about 15 per cent in the last few
years.
Findings of the two recent reports on compliance in the Indian pharmaceutical industry are not encouraging. While the
regulatory action is not unusual to the Indian pharmaceutical companies and the companies have also demonstrated their
capability of resolving the issues. However, in the subsequent inspections the same companies have found themselves in
deeper trouble, this raises a serious question. Why do the pharmaceutical companies find it difficult to comply with the
GMP/ Quality requirements when they know what is expected by the regulators? The simple yet complex answer to that
question is, “the shortage of skilled manpower”. Though this is not the only reason, it has been identified as a key reason
in both these industry reports.
Leading pharmaceutical companies seek to achieve and maintain world-class excellence in all aspects of pharmaceutical
quality from research and development through manufacturing. In pursuit of this goal, savvy companies continuously
strive to upgrade and improve the development and manufacturing set-up to match the standing and business
performance of the company and ensuring compliance with the dynamic regulations. Usually these efforts work for the
companies up to a certain limit, drying research pipeline and constant market pressures of product cost reduction without
compromising the product quality often results in a decision of making these highly specialized resources redundant. This
is contradicting but true to the findings of these two industry reports.
This quality staffing and structures that support the full spectrum of various functions, including research & development,
vendor qualification/ development, manufacturing process development, technology transfer, manufacturing facility &
equipment design, qualification & validation, process validation, trouble-shooting, related computer systems validation,
failure investigations, and continuous product/ process improvements is important for any company to develop &
manufacture a quality product. As all of these are cross-functional, activities developing such skill set takes enormous time
and usually this staff become liability for an organization after completion of a research/ development project(s).
With an intention to fill in this critical competence/ performance gaps RedLotus, “Pharma Technical Services” has been
formed. Along with it’s identified and qualified national as well as international associates and partners (including ex
regulatory officials) it can help pharmaceutical companies in responding to resolve with guarantee any GMP/ Quality issue
arising from a regulatory inspection, such as the USFDA warning letter and/ or prospectively work with the companies in
developing, establishing and continuously improving each element/ system (Quality, Materials, Equipment & Facility,
Production, Laboratory, Labeling & Packaging) that constitutes a reliable and robust GMP/ Quality compliance system.
According to a conservative estimates, about 25 percent of the costs of bringing a pharmaceutical product to market
comes from manufacturing expenses. By adopting optimal structures and strategies for manufacturing technical services,
companies can maximize resources while positioning the function as an improvement arm for processes across the supply
chain. RedLotus, “Pharma Technical Services” can play a critical role in ensuring that safe and efficacious products reach
the market by the most cost-effective methods possible and in guiding the companies at different stages:
(a) During the manufacturing process/ product development stage in designing and selection of right facility,
equipment & technology, their qualification, process validations, data handling, computer system & critical support
systems validation, and establishing robust quality assurance and management systems/ processes.
(b) During the regulatory approval phase in preparing for the regulatory approval inspections by performing mock
inspections, identification & resolution of GMP compliance risk/ gaps, staff training, resolution of regulatory
inspectional findings/ observations.
(c) During the commercial manufacturing phase in trouble-shooting, failure investigations, continuous process and
quality systems performance verification and improvement.
All of the above – if done well – can avoid regulatory challenges, costly product recalls and facility shutdowns.
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About us
Along with it’s identified and qualified, national as well as international associates and partners (including ex regulatory
officials) RedLotus, “Pharma Technical Services” brings in years of collective experience in the areas of a drug substance
as well as a drug product development, analytical method development & transfer, technology transfer, manufacturing,
quality assurance & control, regulatory affairs, pharmaceutical engineering qualification and validation and supply chain.
Our Vision
To be the leader in the delivery of Pharma Technical Services.
Our Mission
To contribute to our customers’ success by helping them develop deeper and better understanding of technical aspects
necessary for achieving GMP/ Quality compliance and manufacture quality products.
Our Services
QA & GMP Compliance
• Quality Management System – Design & Effectiveness Reviews
• GMP Audits – Process Design, Review & Performing (Vendors, Suppliers, Service Providers, Mock Regulatory
Inspections, Data Integrity, Sterility Assurance)
• GMP Risk/ Gap – Analysis & Mitigation Plans
• Training – GMP Compliance, QMS, Data Integrity, Special – Sterility Assurance
Regulatory
• Regulatory Filing Document – Preparation and Reviews
• Regulatory Compliance Issues – Response Strategy and Response Drafting/ Preparation/ Review, Issue Resolution &
Remediation Plan
Technical Due Diligence
• Assessment of Client Identified Target – Organization, Facilities, Systems, Products, Processes and Resources for
Capacities, Capabilities, Competence, Performance & Compliance with Current Regulations.
• Gap Analysis – Identification of deficiencies and gaps in compliance and provision of remediation plans
• Assessment of Systems & Controls – Management Controls and Management Personnel Capabilities
Qualification and Validation
• Development – Qualification Policies, Strategy, Validation Master Plan, Qualification & Validation Protocols & Reports,
Sterility Assurance Plans, Cleaning Validation, Computer System Validation, Process Validation, Sterilization/ Bio-
decontamination Process, Media Fill, Analytical Methods (Chemistry & Microbiology).
• Reviews and Gap Analysis – Regulatory Compliance, Suitability & Adequacy, Sterility Assurance, Media Fills, Trend
Analysis, Statistical Process Analysis, Annual Product Reviews.
• Guidance & Training – Qualification & Validation, Sterility Assurance, Media Fills, Aseptic Manufacturing
• Investigations – Failures Investigation, Guidance, Reporting, Review and CAPA (product testing, stability,
environmental monitoring, market complaints, sterility, media fill etc.) and Position Papers
• Execution – Coming soon
Training
• General & Specific Training – GMP & Compliance, Qualification & Validation, Quality Management Systems,
Continuous Process Improvement, Sterility Assurance, Sterilization Processes etc.
• Custom Training – Depending upon the specific customer need.
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Design & Engineering
• Development – Conceptual Facility Design, User Requirement Specifications (Facility, Equipment & Critical Support
Systems), Factory Acceptance Testing, Facility/ Equipment Maintenance Plan and Processes, Instrument Calibration
Plan and Processes.
• Reviews and Gap Analysis – Facility Design, Equipment & Critical Support System Design and Specifications, Facility/
Equipment Maintenance Plan and Processes, Instrument Calibration Plan and Processes.
Mentoring & Advisory
• Manufacturing Philosophy and Strategies.
• Strategic advisory and/ or mentor role
• Mentor teams/ chosen professionals to meet challenges of operations and business
• Consulting role in project overviews and management
• Providing strategies for setting-up pharmaceutical business right from concept to operation.
• Operational excellence
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Founder Biography
Manish Bhatkar is an experienced pharma professional, diligent in his core functional area
(pharmaceutical technical operations) and committed to the profession. Before founding RedLotus in
2016, in his 25 years of service, he has discharged executive as well as leadership responsibilities in the
areas of design & development, manufacturing, qualification & validation, operations management,
quality assurance, quality management, audits & compliance, regulatory affairs, technology transfer,
project management, and technical consulting. He has worked in R&D, API’s, formulations and
technical consulting environments and has demonstrated equivalent capabilities in managing
manufacturing, technical as well as quality operations with ease.
He was instrumental in establishing and growing the validations & GMP compliance services business vertical for a
German pharmaceutical engineering house Pharmaplan GmbH (Now, NNE Pharmaplan) in India. As head of the Dabur
Oncology Plc. Operations, in his 5 years tenure in UK, he single handedly lead the efforts in resolving complex
technological, regulatory and GMP compliance issues (including USFDA warning letter) that resulted in making
commercial manufacturing and product supplies possible from the site. As head of Lupin Limited’ Technical Services, he
lead the mission to transform the quality mindset and culture at their Goa manufacturing facility for meeting the
exceptional and extreme Japanese quality requirements/ expectations. International experience of working in different
geographies and work cultures helped him further strengthen his technical as well as leadership skills and capabilities.
His main area of expertise is aseptic processing & areas of interests are sterility assurance, manufacturing technology,
process validation, failure investigations, trouble-shooting, continuous improvement and resolution of complex technical/
regulatory/ GMP issues. Additionally, he has lead team of experts in preparing the regulatory filings, facing GMP
inspections / audits and responding to the inspectional observations of various regulatory agencies, such as WHO, ISO,
USFDA, UK-MHRA, ANVISA, ENVIMA, Russia, Romania, Hungary, Germany etc.
Manish has worked with medium to large, well respected pharmaceutical products manufacturing and services
organizations like Dr. Reddy’s Laboratories Ltd., Lupin Limited, Dabur Oncology Plc. UK, Pharmaplan (India) Ltd., and
Zydus Cadila. He has been involved in many projects from concept design to successful delivery of commercial product to
the continuous improvement phases and also led organization(s) efforts and teams in managing and resolving regulatory
challenges like regulatory review/ inspectional observations, warning letters and consent decree.
He is a postgraduate in Pharmaceutical Sciences and an active member of professional associations like ISPE, PDA, and
IPA. In addition to being a pharma-professional he is also a regular speaker in industry & academia seminars/ conferences
and a trainer on the topics like qualification and validation, process validation, quality systems etc. He is well travelled and
has also worked on short and long international assignments particularly in the UK, USA & Japan.
