V. S. International Pvt. Ltd

Transcription

1 V. S. International Pvt. Ltd Innovation in medicine Partners In human care for today and tomorrow... Unit I - Daman

2 V. S. International is a Healthcare Company with it s Corporate Head office at Mumbai, India. We are engaged in the Manufacture, Marketing and Export of Pharmaceutical Products, Healthcare Products, Medical Devices, Hospital Consumables, Laboratory Equipments & Furniture. Since our inception in 1997, we have stood for reliability, Quality and Integrity An ISO certified Company with WHO GMP certified & PIC/S compliant plant in India; we tailor our products and services to meet the ever changing demands of our wide and varied client base spread across more than 30 countries.

3 AUTHORISATIONS Manufacturing License - Valid up to 19/10/2019 Schedule M Certificate - Valid up to December 2015 WHO GMP Certificate - Valid up to March 2017

4 Awards BOI Top 100 SME Award 2012 D&B Indian Exporters Excellence Awards 2015 BOI Top 100 SME Award 2013

5 Located in the Union Territory of Daman. The location offers excellent connectivity to Maharashtra & Gujarat By road: 170 kms from Mumbai By railway: Nearest railway station is Vapi By air: Mumbai is the nearest Airport

6 Plant Layout

7 Ground Floor Packing I, Change Room & Ware house. Total Factory Area 4,000 Sq. Mtrs. First Floor Second Floor Third Floor Administrative Office, Engineering & Quality Assurance & PM Store. Production Area - Tablets & Capsules Manufacturing. HVAC & Utility Service Area. Fourth Floor Quality Control & Packing II.

8 Annual Production Capacity Capsules 150 million Tablets 1.5 billion

9 Product Therapeutic Category Anti Infective Anti Malarial Anti HIV Antipyretic & Analgesic Cardiology Diabetology Gastroenterology Gynaecology Neuropsychiatry Respiratory Vitamins & Minerals

10 Production of Oral Dosage Tablets Capsules 3 GRANULATION AREAS 500 Ltr. Fluid Bed Processor (Pam Glatt) 500 Ltr. Fluid Bed Drier & 700 Ltr. Rapid Mixer Granulator 125 Ltr. Fluid Bed Processor (Pam Glatt)

11 Manufacturing 8 Compression Blocks with high speed Compression Machine 2 Autocoaters: Ganscota 60 and Neocota 48

12 Manufacturing 3 Separate IPC Store Areas for Granules, Tablets & Capsules Fully Automatic Capsule Filing Machine, AF-90T

13 Seven Packing Lines: 2 Alu/Alu Blister Packing Machines. 3 Rotary Blister Packing Machines with Cartonator. 1 Strip Packing Machine. 1 Fully Automatic Bulk Packing Line with Cartonator. 1 Leaflet Folding Machine. All packing lines are equipped with on-line printing, on-line camera system and on-line weight check system

14 QUALITY QUALITY POLICY We are committed to maintain and review the effectiveness of the quality management system through a genuine pursuit of continuous improvement. The Company shall establish and maintain high standards of quality for its products, meeting cgmp norms Products shall be manufactured and marketed meeting all quality parameters related to identity, purity, safety and efficacy through well-defined quality assurance and validated systems. The Company shall comply and constantly update with current national and international regulations as applicable and continuously strive for achieving global standards. Continuous training shall be given to the employees in the organization to enhance their skills in performing their assigned tasks.

15 Validation Master Plan QUALITY Exceptions & Changes Management Instruments & Equipments URS Product & Process Process Validation QC Systems Quality Improvement & CAPA Quality Risk Management Design Qualification Cleaning Validation Production Systems Material Management Quality Monitoring & Review Installation Qualification Area Validation Documentation System Quality Management Commitment Quality Policy Operational Qualification Performance Qualification Facilities & Equipment Personnel & Training

16 PROCESS CONTROL FLOW Material Procurement Vendor Approval Sample Check Material Receipt & Storage Line/Area Clearance Sampling, Testing & Approval QUALITY QC Function QA Function Line/Area Clearance Dispensing Manufacturing Process with IPQC Line/Area Clearance Testing & Packing release Packing Process with IPQC Finish Product Release Finish Product Testing Finish Product Dispatch

17 QUALITY Procurement of RM / PM Sales & Distribution Process Planning Storage Quality Assurance Production Packaging Process Control Inspection & Testing

18 QUALITY Laboratory Controls System Packaging & Labeling System Quality System Production System Change Control Deviation Control Market Complaint Annual Product Review Material System Facilities & Equipment System Product Recall

19 Self Inspection System Quality Assurance Annual Calendar Trained Auditors Frequency 6 months Rationale for Audit Scope Findings of Last internal audit, External audit findings and Checklist. Documentation : Audit report, Compliance report and Summary report Handling of Complaints Established procedure Log in of the Complaint on Receipt Acknowledgement to Complainant Investigation and Report Corrective And Preventive Action (CAPA) Information to Regulatory body(s) (if applicable)

20 Annual Product Review Quality Assurance Written Procedure Process and Quality Parameters Review of : o Deviations o Regulatory Changes, Pharmacopoeia o Change in Facility / Equipment etc. Trend Analysis of Critical Parameters Recommendations Documentation : Reports with Graphical presentations Product Recall Recall Strategy Recall of products from Domestic / Export Market Investigation and Report Information to Regulatory body(s) (if applicable)

21 Quality Control Chemical Instrument Section Microbiology Lab PM Analysis

22 Quality Control Training And Analyst Qualification Storage Of Toxic Materials Equipped With Safety Equipment Safety Shower Eye Wash fountain Gloves, Masks & Goggles Fume Hood Defined Responsibilities Documentation Raw Data Sheet, Sampling Procedure, Testing Procedure

23 Stability Study Program Quality Control Accelerated Storage Condition 40 ± 2 C & 75 ± 5% RH Long Term Storage Condition 30 ± 2 C & 65 ± 5% RH Long Term Storage Condition 30 ± 2 C & 75 ± 5% RH Conditions For Stability Study Change in Formulation/Process Change in Primary Pack Change in Manufacturing Location Change in source of API Routine study

24 Quality Control Raw Materials Packaging Materials APIs 100% Sampling Primary PM Inhouse sampling procedure Excipients Statistical Sampling Secondary / Tertiary PM Inhouse sampling procedure Retention Period Up to 12 months after expiry Retention Period - Up to release of PM, Printed PM in report

25 Objectives Type Topics Training Improving Knowledge & Skill Induction Identified by HOD s Improving cgmp compliance Annual Training cgmp, SOP, Validation Developing Positive attitude SOP Training Based on Audit findings On-Job Training Safety, Environment & Health Unit Operations, Technical Skills

26 Safety Personal Protective Equipment Sophisticated Fire Fighting System Safety Showers First Aid Kits Eye wash fountains

27 Utilities THERMIC FLUID HEATER AIR COMPRESSOR DG SET Capacity: KCAL/HR Capacity: 283 CFM Capacity: 625 KVA

28 Manufacturing : 21 AHU (Class 1 Lac) Microbiology Department : 01 AHU (Class 1 Lac)

29 Purified Water System

30 ETP Diagram

31 Managing Director ORGANOGRAM Director - Technical Manager - QA GM Plant Operations Sr. Manager - Production Planning Head - QC Head HR & Admin Head - Production Head - Packing Head - Engineering Head - Stores Engineer - IT Executives Section Head Microbiologist Instrumental Analyst Chemical Analyst HR Assistant Executives & Machine Operators Executives & Machine Operators Junior Engineers Executives

32 THANK YOU! Registered Office: V. S. INTERNATIONAL PVT. LTD. A-204, Neelam Center, Hind Cycle Road, Worli, Mumbai Phone: Fax: Plant : V. S. INTERNATIONAL PVT. LTD. Plot no. 17& 18, Golden Industrial Estate, Somnath Road, Dabhel Daman (UT) Phone: / 788 Telefax: