MINESH KALYAN
Title / Position: Pharmaceutical GDP Consultant RP/RPi E-mail Address: mineshkalyan@pharmasphere.co.uk Telephone: +447396530015 Website URL: https://pharmasphere.co.uk/ Social Media Profiles: linkedin.com/in/minesh-kalyan- a4a3888a Location: United Kingdom Languages spoken: English, Gujarati, Hindi, Punjabi Geographic Areas Covered: UK, EU Name of Firm: Pharmasphere Ltd No. of Practising Consultants: 1
Educational / Professional Background
Academic Qualifications (degrees, diplomas, etc.)
Bachelor of Science (Hons) in Chemistry - De Montfort
University, Leicester, England.
Certifications and Accreditations relating to
Pharmaceutical Good Distribution Practice (GDP)
GDP Responsible Person (RP) Cogent Gold Standard
Membership of relevant professional organizations or
associations
Member Of The Royal Society of Chemistry (MRSC); Member of
The Pharmaceutical Quality Group (PQG); GDP-UCI.
Involvement in GDP-UCI
Member of Audit & Certification Primary Workgroup
Member of GDP Knowledge Bank WorkGroup
Professional Skills, Experience and Expertise
No of years of experience in Pharmaceutical Good
Distribution Practice (GDP)
12
Previous Companies worked for in the Pharmaceutical
Industry
PASAB Ltd; Walgreens Boots.
Specific areas of specialism or particular experience
Auditing, QA consultancy Remediations Deviations and CAPA
Risk assessment.
Familiarity with Specific Regulatory Frameworks and
Guidelines
MHRA and GDP Green Guide.
Relevant Training or Courses Attended
Several courses on GMP, GDP and Auditing; RPi Training Seer
Pharma; RP Forum PQG; MHRA & Seer Pharma Symposia.
Software or Technical Skills related to
Pharmaceutical Supply Chain Management
Extensive experience in inventory management systems, QMS
software, data analytics, reporting tools, ERP systems, and
RFID/Barcode technology.
Client Testimonials / References
Professional references
Available on request.
References or links to case studies / past projects
Contract Responsible Person on different clients WDA(H) - Design,
implement, & maintain Quality Management System (QMS).
Designed audits to cover all aspects of GDP.
Conducted GDP audits for a wide range of wholesalers. Providing
GDP training. Completing due diligence and bona fide checks for
wholesalers.
Specializing in identifying gaps in GDP compliance, then completing
quality risk management, and change control. GDP transportation
validation. WDA(H) Remediation.
Other Information
In their own words:
“A dynamic and resourceful GDP specialist. Proficient in ensuring GDP compliance standards are met. Exceptional interpersonal communication skills with proven ability to build and maintain long-lasting working relationships with key stakeholders”
Good Distribution Practice - Universal Compliance Initiative
GDP CONSULTANTS
