US FDA / PIC approved oncology injectable facility

Sunmoon  Facility have received US FDA and Romanian PIC(s) approvals.

 

This facility was commissioned in June 2007 and many ongoing  registrations. Manufacturing capacity is 2.0 million lyophilised or liquid vials per year with batch size from 3000 vials (50 ml) to 20,000 (1ml) per day. Filling machine is from Groninger Germany with speed of 300 VPM ( 2to 10 ml) with change parts upto 60 ml.

Considering the cytotoxic nature of the products, the production unit is designed as self contained and dedicated facility isolated from other production areas.

Separate dedicated facility is provided for the manufacturing and storage of these products. This also includes the dedicated warehouse, dedicated utilities and HVAC systems. No other products are manufactured or stored in this facility. An isolator is provided in the area for handling of the cytotoxic powder. Activities such as sampling, dispensing and formulation are done under isolator.

All the contact accessories and equipments are suitably inactivated after use. Inactivation is done in place or by taking the equipment to washing area. Waste generated from the facility is collected in a separate tank, suitably inactivated and then disposed off to common effluent stream.

Separate area is provided within the facility for cleaning the external surface of vials and to remove the likely traces of cytotoxic material if any.                

Laboratories are equipped with negative pressure hood, fuming hood and personnel protective equipments for handling of cytotoxic powders and hazardous chemicals.


HVAC system controls and monitors the inside facility environmental conditions, namely temperature, RH, pressure and cleanliness as appropriate for human comfort and product/material containment. HVAC system is designed to achieve required conditions for the operation. The AHUs are segregated in to different zones. AHU zoning is done considering the criticality of operation.


Qualifications and Calibrations:


Having a well established qualification system to ensure that each piece of equipment / instrument is suitably qualified before being put in to actual use. Extent of qualification is determined based on the impact assessment.

Procedures and plans are available for the calibration of the measuring instruments. All measuring instruments are calibrated as per the predefined schedule and are identified with calibration status label.

Documentation control is the responsibility of Q.A. department. All master documents associated with products and processes are identified and controlled.

SOPs describing preparation, issue, usage, approval, review and archival of various types of documents are available. All product and process related documents are prepared as master documents which are   thoroughly reviewed and finally approved by Q.A. These documents are maintained as controlled documents and copy of master document is issued by Q.A. to the user department for the usage.

All master documents and completed manufacturing and testing records are archived in the central document storage  with Q.A. department.

Each of these documents are   periodically reviewed and records are maintained in the form of History sheets.
Records for each batch (manufactured and tested) are  maintained by Quality Assurance department which gives complete history of the manufactured batch.

Records associated with environmental monitoring, microbial monitoring of water and air, personnel monitoring records, performance of HEPA filters in the manufacturing and testing areas with the help of climet/ Met-One airborne particle counters are regularly reviewed by Q.A.

Quality of WFI (Bulk) and purified water is checked periodically. The water for injection (Bulk) is tested for endotoxins, viable count and chemical analysis daily results are recorded.

Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes a patent infringement.


Injectable facility :


A state of art injectable ( vial, ampoule and pre filled syringe including lyophilized vials).

The unit has the following capacities:

Ampoule – 75 million aseptic and terminaly streilised products

Vial - 15 million

Lyophilized - 7.5 million

Pre filled syringes - 4.5 million

Unit has following certifications:

Prequalification WHO GMP certification from WHO, GENVA

GMP certificate from Republic of Yemen. WHO GMP certification.



WHO GMP facility:


A state of art oncology injectable (liquid and lyophilized vials).

The unit has following capacity

Capacity is 2.0 million lyo or liquid vials per year .

The unit has following certifications:

WHO GMP certification

FDA certification


FDA approved solid oral oncology facility


FDA approved and schedule M compliant solid oral facility for oncology products.

The unit has a capcity of 10 million solid orals per year.

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