Polestar Power Industries (Pharma Division) Pioneer Manufacturer Of Beta-Lactum & Cephalosporin

Transcription

1 Polestar Power Industries (Pharma Division) Pioneer Manufacturer Of Beta-Lactum & Cephalosporin R Polestar Power Industries (Pharma Division) Vill. Damuwala, Haripur Road, Barotiwala, Tehsi l Baddi, Distt. Solan, (H.P.) info.polestarpharma.com

2 COMPANY S CAMPUS Polestar aims to create significant impact in (Beta Lactum) providing optimal care to the patients Polestar production equipment list given below : R Tablet Section: Dry Syrup Section: I. Sifter II. Roll Compactor III. Multi mill IV. Granulator V. Vacuum tray dryer VI. Blender VII. Compression machine with metal detectors VIII. Auto-coater IX. Alu-Alu Blister packing machine X. Strip packing machine XI. Packing conveyor I. Sifter II. Multi mill III. Granulator IV. Vacuum tray dryer V. Blender VI. Automatic air jet cleaning machine VII. Automatic rotary dry syrup powder filling machine VIII. Cap sealing machine IX. Induction sealing machine X. Automatic high speed measuring cap placement machine XI. Sticker labeling machine XII. Packing conveyor Success in management requires learning as fast as the world is changing 01 10

3 Introduction Polestar is a dedicated facility for Betalactum (Oral Solid Dosage Form). The facility is designed to handle special products like Clavulanic Acid which requires low RH area. This site is located on 823 Square meters plot in three floors i.e. ground floor dedicated for store, first floor dedicated for production and second floor for QA/QC and administration. The facility includes dedicated Storage Area for Raw Materials and Packaging Materials and segregated floor for the manufacturing of Cephalosporin (Oral Solid Dosage Manufacturing). It also has a separate full-fledged utilities section. Induction Sealing Visual Inspection Compressor For analysis of products it has well equipped and self-sufficient Quality Control Laboratory with sophisticated analytical instruments like HPLC from Agilent, UV spectrophotometer and also Karl Fischer Apparatus, Stability Chambers, etc. Microbiology section is equipped with autoclave, LAFs, Zone Reader, TOC etc., The Basic Objective of the Manufacturing Facility Is: To maintain un-interrupted supply of Finished Products. Manufacturing of products as per current Good Manufacturing Practices (cgmp). Maintaining customer satisfaction with zero defects. Minimizing production wastages by following standard operating procedures (SOPs) Quality Policy: Polestar is committed to develop, manufacture and supply drug products incorporating the latest technology, compliance of regulatory requirements, consistency in quality with strong technical support surpassing the customer s expectations. Polestar believes in working as a team by commitment to adopt and implement quality management system in the organization and its continuous improvement in products and services for ultimate satisfaction of all our valued customers by involvement of all team members. BLENDER (FOR TABLETS/ DRY SYRUP) Environmental Policy Polestar is responsible manufacturer of pharmaceuticals product is committed to take adequate precautions related to environment, health and safety in developing, manufacturing, testing, storing, handling and distribution of both existing and new products and in its business. It is our policy to provide a workplace free from accidents, injuries and exposure to hazardous chemicals, conserve natural resources and prevent pollution to protect the environment. Towards this, we have set our objectives. SITE HIGHLIGHTS Clean pollution free isolated environment. Unidirectional man & material flow. Clean room systems. Access control system and door interlocking. Service area. Process wise Air Handling Units (AHU). HEPA filtered air in process area of 0.3 micron. Using the latest GMP model of machines & equipment

4 Design to prevent external contamination. All windows and doors are of double glazed PU (Poly Urethane) painted, flush type having view panel of glass. All critical areas are maintained as per process requirement. The flooring of critical areas has self-leveling PU flooring. Covings with PU & Epoxy are provided on all sides of the walls in all areas. AHUs have PRE-FILTER (10µ), FINE FILTER (5µ) & HEPA FILTER (0.3µ) with 99.97% Efficiency of retaining 0.3µ and above particulate matter. Terminal HEPA filters installed in all critical area AHUs. Class 100,000 maintaining for (OSD manufacturing area). Temperature, Relative Humidity & pressure differential are maintained as per requirement. Regular validation frequency to monitor the performance. PRODUCT LIST Quality Assurance 1 Separate QA department provided from quality control & production Department. 2 Separate IPQA office provided in production area for IPQA ch e cksample collection, release of products, validation sample collection & cgmp compliance. 3 Written procedure for issuance of controlled copy of all documents in company premises and uncontrolled copy to out-side, the total documents are controlled by QA. (TABLET CEPHALOSPORIN) 4 Adequate controls on semi finish products, finish products, finish products release and other control for calibration & validation. 1 Cefixime DT (50mg, 100mg & 200mg, 200 Coated & with Lactic Acid Bacillus) 2 Cefixime & Potassium Clavulanate (162.5mg & 325mg) 3 Cefixime & Ofloxacin, Cefixime & Azithromycin & Cefixime & Ornidazole 4 Linzolid 600mg & Cefixime 200mg 5 Cefpodoxime 50mg, 100mg & 200mg 6 Cefpodoxime & Ofloxacin, 7 Cefpodoxime & Potassium Clavulanate, Cefpodoxime & Azithromycin 8 Cefuroxime Axetil 250mg & 500mg 9 Cefuroxime Axetil & Potassium Clavulanate (250mg mg, 250mg + 125mg & 500mg + 125mg) Film Coated 10 Cefadroxil (250mg DT & 500mg Coated) 11 Cefadroxil 500mg & Potassium Clavulanate 125mg 12 Cephalexin 250mg DT 13 Cefdinir 300mg (TABLET BETALACTUM) Amoxycillin Range 1 Amoxycillin & Potassium Clavulanate (228.5mg, 375mg, 625mg & 1000mg) Amoxycillin 500mg, Potassium Clavulanate 125mg & Lactic Acid Bacillus 60 million 2 spores Regular self -inspection (AUDIT) program by audit team through controlling of QA department. All QMS related documents like handling of market complaints, Change Control, Deviation, OOS etc. available with QA. Adequate area under lock & key for storage master documents, obsolete documents & filled documents and only authorized persons are allowed in this area. Store Details: Records are kept in a manner permitting trend evaluation. Adequate controlled area designed with sufficient space for various category of material and s eparate area provided for: Raw Material Packing Material Sampling area (API & Excipients Sampling Under RLAF) Dedicated dispensing area for API & Excipients (Dispensing Under RLAF) Finished Goods Separate area provided for quarantine, under-test, approved & reject material

5 Quality Control Separate area provided from manufacturing department, having the qualified & experienced staff. Adequate area having the required storage condition provided for keeping the reference sample. The quality control department, conducted the stability studies of the products to ensure their shel f life and adequate area provided for accelerated & long term stability study. All the instruments are calibrated in house & outside party as per requirement. Major Equipment's Available: HPLCs, TOC Analyzer, Dissolution Apparatus, U V -Visible Spectrophotometer, KF Titrator, Autoclave, Incubators, Stability Chambers. All Other Laboratory Equipment's used in Qualitative & Quantitative Analysis Following Sections Are Available: Chemical Lab Instrumental Lab Microbiology Lab Stability Area (DRY SYRUP CEPHALOSPORIN) 1 Cefpodoxime Oral Suspension 25mg, 50mg & 100mg Cefpodoxime & Potassium Clavulanate Oral Suspension 50mg mg & 100mg mg 3 Cefixime 25mg, 50mg & 100mg 4 Cefixime & Potassium Clavulanate 50mg mg & mg 5 Cefixime 50mg & Ofloxacin 50mg 6 Cefuroxime Axetil 125mg 7 Cefuroxime Axetil 125mg & Potassium Clavulanate 31.25mg 8 Cefdinir Oral Suspension 125mg 9 Cefprozil for Oral Suspension 125mg 10 Cefaclor Oral Suspension 50mg 11 Cefaclor Oral Suspension 125mg 12 Cephalexin Oral Suspension 100mg 13 Cephalexin Oral Suspension 250mg 14 Cefadroxil 100mg (DRY SYRUP BETALACTUM) Amoxycillin Range 1 Amoxycillin & Potassium Clavulanate (228.5mg & 457mg) We make a living by what we get, But we make a Life by what we give

6 CLIENTS LIST Polestar works with more than 100 clients, name of some important party working with us along with their logo given below : Production Equipment Our Production Equipment For Manufacturing Of Tablets, Dry Syrup (Beta Lactum) & Including Combinations of Potassium Clavulanate. Some Pictures of equipments : INDOCO REMEDIES LIMITED (LOAN LICENSE) VACUUM TRAY DRYER TABLET COMPRESSION MACHINE TABLET COATING MACHINE AIRJET BOTTLE CLEANING MACHINE Trust Takes Years To Build Second To Break And Forever To Repair 05 06