ABC Healthcare (Symbolic name) is a dedicated facility for Manufacturing Antibiotic Cephalosporin (Oral Solid Dosage Form- Tablet & Dry Syrup). The facility is WHO-GMP Certified. The facility is designed to handle special products Cephalosporin.
Our plant is brand new and made as per the international guidelines. And we are ready for various international audits from various countries
Our Pre-Formulated Intermediates:–
1] Cefuroxime Axtel Taste Masked Granules for Oral Suspension USP
2] Cefixime Trihydrate Taste Masked Granules for Oral Suspension USP
3] Cefpodoxime Proxetil Taste Masked Granules for Oral Suspension USP
4] Cephalexin Monohydrate Taste Masked Granules for Oral Suspension USP Etc.
This site is the area on 220000 Square feet plot and plant constructed in 36000 square feet, on ground floor production area, raw material stores, and finished goods stores. And on the first floor QA/QC department. The facility includes a dedicated Storage Area for Raw Materials and Packaging Materials. ABC Healthcare is also has a separate F & D area.
For analysis of products, it has well equipped and self-sufficient Quality Control Laboratory with sophisticated analytical instruments like brand new latest HPLC from Shimadzu- P Series, UV spectrophotometer and also Karl Fischer Apparatus, Stability Chambers, etc. Microbiology section is 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) & as per WHO Standard.
- Maintaining customer satisfaction with zero defects.
- Minimizing production wastages by following standard operating procedures (SOPs)
- ABC Healthcare 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.
- ABC Healthcare 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.
ABC Healthcare is the responsible manufacturer of pharmaceuticals products is committed to taking adequate precautions related to the environment, health, and safety in developing, manufacturing, testing, storing, handling, and distributing 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.
- 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.
- 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 manufacturing areas has 3mm epoxy 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.
|Tablet Section||With a Manufacturing capacity of 6 Lakh per shift.|
|Dry Syrup Section||With the Manufacturing capacity of 15000 bottles with 30ml capacity per shift.|
The adequate controlled area designed with sufficient space for various categories of the material and separate 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.
Production Equipment’s Tablet Section:
|SR. NO.||Name of Machine||Quantity.|
|4||Double Stirrer Oscillating Granulator||1|
|7||DB Tooling Compression machine||1|
|8||Tablet Metal Detector||1|
|10||Alu-Alu Blister packing machine||1|
Dry Syrup Section Machinery:
We are handling Glass as well as HDPE bottles. List of machinery in the dry section.
|SR. NO.||Name of Machine||Quantity.|
|2||Automatic air jet cleaning machine||1|
|3||Bottle visual pre inspection conveyor||1|
|4||Automatic Two Head Auger Fully Auto Powder filling machine||1|
|5||Fully Automatic Single Head ROPP/Screw capping machine||1|
|6||Fully auto measuring cup Placing & Pressing Machine||1|
|7||Fully auto measuring cup Placing & Pressing Machine||1|
|8||Induction sealing machine||1|
|9||Automatic high-speed measuring cap placement machine||1|
|10||Sticker labeling machine||1|
- Separate QA department provided from quality control & production Department.
- Separate IPQA office provided in production area for IPQA checks, sample collection, release of products, validation sample collection & cGMP compliance.
- 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.
- Adequate controls on semi finish products, finish products, finish products release and other control for calibration & validation.
- 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.
- Records are kept in a manner permitting trend evaluation.
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- 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 shelf life and adequate area provided for accelerated & long-term stability study.
- All the instruments are calibrated in house & outside party as per requirement.
Following Sections Are Available:
- Chemical Lab
- Instrumental Lab
- Microbiology Lab
- Stability Area
Major Equipment’s Available:
HPLCs, TOC Analyzer, Dissolution Apparatus, UV-Visible Spectrophotometer, Karl Fisher Titrator, Autoclave, Incubators, Stability Chambers, etc.
All Other Laboratory Equipment’s used in Qualitative & Quantitative Analysis
For more details please call or Whatsapp on 9812446733
The author has 20 years of experience in the Pharmaceutical Manufacturing Companies. Have exposure to all audit documents for WHO-GMP, PIC/S, USFDA, Export documents, US-FDA documents, Validation of Pharma machinery, and Quality Control Instruments. Expert in Pharma Plant Setup and sale and acquisition of running pharma company.