bilcare_gcs quality and regulatory overiew
TRANSCRIPT
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Quality & Regulatory Overview
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Quality Policy
Team Bilcare is committed to offer a wide range of Innovative Services
to the Global Pharmaceutical Industry that includes
Clinical Trial Manufacturing, Packaging Design and Development, Labeling,
Sourcing of Innovator Drug Products, IVRS/IWRS
and Storage & Distribution of Investigational Medicinal Products.
Our endeavor is to provide Credible, Safe, User-friendly, Cost effective and
Creative Solutions for ‘Clinical Trial Material Supplies’ Business,
together with the Strategic Partners and are aimed at our Customers’ Success.
Our focus on Customer Satisfaction through Consistency in Quality,
Cost and Service Standards is benchmarked against the Global best.
Excelling through continual Self Improvement is a way of life at Bilcare.
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Quality Management System
Quality Management System’s in compliance with:
cGMP: current Good Manufacturing Practices
GCP: Good Clinical Practices
GDP: Good Documentation Practices and Good Distribution Practices
GWP: Good Warehouse Practices
ISO 9001; 2008 – QMS Requirements
Annexure 13 of Orange Guide: Manufacture of Investigational Medicinal Products, EU
21 CFR part 11
PIC/S GMP Guide
Schedule M and Y: Drugs and Cosmetic act 1940 & Rules 1945, India
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Documentation Levels
Quality
Manual & SMF
VMP & SOPs
Flow Charts, Specifications
Records & Formats
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Roles and Responsibilities of Quality
Documentation Management
Quality SystemsArea / Equipments / Instruments Control
Inspection
Monitoring Batch Releases TrainingAudits – Internal/ External /Vendors
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Few important SOPs in QA
Management of SOPs
SOP Archival
Good Documentation
Practices
Deviation controlChange control
system
Complaint handling
Management of Corrective and
Preventive Actions
Quality Risk Management
Environment Monitoring
Batch Release
Training
Self inspection/ Internal Quality
Audits
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Continual Improvements
Implementation of Systems through learning from various internal and external audits
Improvements on weak areas identified from Customer feedback and complaints; and strengthening the core areas
Working on points for Improvements after every Management Reviews & MIS meets
Improve knowledge base of employees through various Internal and External Trainings, Reading, Participation in Seminars and Conferences. Investing avg. 80 hours of training per person per year
Effective Communication & Co-ordination with Employees, Management, Vendors, Service Providers & Customers to reduce any gaps
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Certification & Licenses
Local Drug Regulatory Approvals (Licenses PD-191/25 and PD-113/28, valid up-to 16th Sept 2018)
GMP Certificate issued by Local regulatory body valid up-to 16th Sept 2018
ISO 9001:2008 certified , valid up-to 18th June 2016
Scope (ISO 9001:2008)Design of Packing for Investigational Medicinal ProductsSourcing of Innovator Drugs Packaging, Labeling, Storage and Distribution of IMP’s and Innovator Drugs
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ISO & GMP Certificates
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Local Drug Regulatory Approvals
Licenses PD – 191/25 & PD – 113/28, Valid till 16th Sept 2013
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Local Drug Regulatory Approvals
Storage & Distribution License – Form 20B & NDPS License (Controlled Substances)
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Knowledge & Expertise
Regulatory Guides across the Globe
cGMP, GMP, GDP, GLP and GCP
Keeping eye on current updates on clinical trial regulation
Scientific & Legal Expertise to find legal solutions
Assurance of meeting timelines with Efficient & Effective way of handling projects
Value additions in terms of cost & technical aspects
Expert Staff - Pharma Graduates & Post Graduates, Microbiologist and Doctorates
Acquire & Develop the required Regulatory management skills for driving Clinical Trials effectively and become One Stop Shop for the CROs and Sponsors
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Regulatory Support Services
Global Clinical Trials Phase II to IV
BA/BE (Bioavailability and Bioequivalence) studies
Controlled Drug substances approvals from Central Bureau of Narcotics and State authorities
Drug Import & Export Licenses
Site endorsement and transport permit for NDPS
Shipping & Transportation Regulation
QP Audit & Batch Release Services
Liaison services with Central & State Authorities for following
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Offers Expertise in Regulatory submissions through technical domain experts
Review of Multiple documents generated before, during, & after Clinical Trials
Value additions in Study Protocols as per regulatory standards
Experience in Harmonized data in terms of content & customized format – reducing review time & duplication
Investigator’s Brochure
Clinical Trial Applications (Protocol, Ethics Committee, Amendments etc.)
Import & Export Permissions (Investigation & Comparator Drugs, Reagents etc)
Global Regulatory Services
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www.bilcareGCS.com
“Experience Bilcare - Experience World Class Services”
Chhanda DasVice President- QA & Regulatory
[email protected] Mob: + 91 992 240 8512
Bilcare Global Clinical Supplies1028, Shiroli, Rajgurunagar, Pune- 410505. India
Tel: +912135 304406 | Fax: +912135 304417