11-03-2014, 03:25 PM
HAB Pharmaceuticals & research Itd
Pharmaceuticals & research.doc (Size: 155 KB / Downloads: 32)
Introduction
Quality is the hallmark of the HAB. At every stage of production from raw meterial of finished products, heighest standard of quality should be ensured with the help of state. Of the- art equipment & trained personal. Likewise to earn enormous goodwill & trust, company maintains an efficient Quality Control Department, It has three wings;-
a) Microbiology section.
b) Analytical section.
c) Packaging section.
The training was concerned with the tests routinely in the QC section. These tests ensure the quality of the product of the Company. Through the production the products & their materials are subjected to different types of tests at four broadly distinctive levels;-
Raw material.
Packaging materials.
Intermediate products.
Finished products.
Moreover, three types of water like potable water, purified water & for injection are used in different industrial purposes including cleaning & manufacturing. So it is necessary to check & control the pathogenic organisms according to the purpose of use.
Air is another factor rather good rather good transmitter of microbes. So, to keep the environment of microbiology laboratory asenic air sampling is routinely done in the section & suitable measures are taken when required.
Ongoing tests done & apparatus used in QCare tabulated in next page.
Installation Qualification
Installation qualification consists of documented verification that all key aspects of the dissolution apparatus are in working condition and have been properly installed in accordance with manufacturer’s specifications in the proper operating environment. The intallation qualification
of a dissolution apparatus should include the following verifications;
Prevantive Qualification
Installation qualification consists of docemented varificaton that all key aspects of the dissolution apparatus are in working condition and have been properly installed in accordance with manufacture’s specification in the proper operating environment. the installation
of a dissolution apparatus should incclude the follwing varification:
prevactive maintence
the installation qualification should document that the dissolution apparatus in enrolled in a prevntive maintenance program to assure that the system continues to operate properly and no component part of the system become incomes inoperable to wear and use.
Calibration
The installation qualification should document that specific devices contained within the dissolution apparatus (e.g., speed, time,and temperature displays) have been calibrated to traceable standards. Documentation should include the date calibration was performed and when calibration is due.
SOPs
the installation qualification should document that all SOPs pertaining to the dissolution apparatus are approved and in place. Applicable SOPs may include preventive maintenance, calibration, document archival, and equipment logbool usage.
Utilities
The installation qualification should the manufacturer’s specification for required utilities and varify that the appropriate utilites are available for the system.For example, utility varification may include confirming that the appropriate electrical power requirements
(voltage, amperage, safety cut-offs) are documented and comply with manufacturar’s specifications.