QA is totally organized and arrangement with object of ensuring that the medicinal products produced are of the quality required for intended use. The QA system appropriates for the manufactured of medicinal products designed & developed as per GMP & GLP.

Production and control operations are clearly specified all necessary controls such as in-process, validations are carried out; finished products are correctly processed and checked.

GMP is a part of quality ensures that products are consistently produced & controlled to appropriate quality standards.

QC is a part of quality assurance concerned with specifically testing with proper documentations and list procedures in which respective tests are actually carried out.

The facility has adequate number of personnel with necessary qualification & practical experience. Organogram is available and all key personnel's job description and respective authority are displayed. The production head ensures products are manufactured & stored with proper documentation, maintenance of his department & premises. Appropriate validations are completed. Quality head is having authority to approve/ reject material / in process/ finished product by evaluation of proper documentation.


Personal hygiene, detailed hygiene programme are established which includes health, hygiene practices & clothing of personnel. All persons are going through a medical examination and are periodically checked in which infection disease, open lesions are properly advised.

The premises are designed in such a way that man movement / material movement is segregated to avoid contamination. All manufacturing areas are provided with class 100000 with positive pressure to avoid risk of cross contamination. Lighting provided is of 300 Lux. Temperature not more than 25oC.

All equipments used are logically positioned and are easy for cleaning. Cleaning procedures are established for every equipment, in cases where dust is generated are provided with RLAF.

Storage area is sufficient to allow orderly storage of various materials. We have controlled Temperature storage areas also.

QC area is separate from production area and designed to suit to carry out the operations. Separate areas are provided for chemical, instrumental & Microbiological tests. We have separate microbiological laboratory which is class 100000 and having separate area for media preparation / bioassay / MLT.

Ancillaries such as change rooms, washing & toilets are properly arrange to facilitate the movement of people.

 

Implementation of Quality Policy:

To achieve quality objective a strong Quality Assurance system has been Formulated, incorporation Good Manufacturing Practices & Good Laboratory Practices.


DESIGNING SPECIFIATIONS:

R & D Team develops specification of Raw Material , Packing Material and finished products in co- ordination with Quality Control.
As per specifications laid down Raw Material/ Packing Materials are Produced by purchase and evaluated by Q.C.


DEVELOPING FORMULATIONS:

The New formulations as well as old formulations are developed / Reviewed in R & D
After successful completion of stability test of 3 batches in R& D, The same formulation is taken for production. R& D and production Team together monitor first 3 production batches.
During the scale up process, if any changes are required, R&D & Production team confirms those changes which are then implemented and documented.


DOCUMENTATION:

R & D ensures that the manufacturing process have approved &authorized Standard Operating Procedures and all products have authorized Master formula Records.
Relevant SOPs that cover all manufacturing operations are available.

All in process checks & controls at various stages in the process of Manufacture are recorded


CALIBRATION & VALIDATION:

All manufacturing equipment & process are validated as per the Validation protocol
All testing, indicating & recording instruments are calibrated as per Protocol.


TRAINING:

The training of employees is conducted on a regular and ongoing basis


TRAINING:

Regular maintenance is given due importance & is carried out as per
Planned schedule.