Our Inspecting System

As part of the self-inspection system, the Quality Control Department performs an internal audit of the Production and Quality Control Department on a regular basis. This includes scrutiny of BMR and Quality Control reports and documents for their validity. The Quality Control Officer also performs regular inspection of the premises and facilities to ensure compliance of the same with Schedule 'M' of Drugs & Cosmetic Rules 1945.

SELF INSEPCTION AND QUALITY AUDITS.

To   find out   whether the organization and its activities comply with all aspects of GMPs in production and quality control.  To detect shortcomings in the implementation of GMPs, prepare a   report and submit to the management, so as to direct an effective follow up program.

SELF INSPECTION TEAM

A team of experts drawn from different disciplines such as quality assurance, quality control, production, engineering, general affairs should be finalized.

FREQUENCY OF SELF INSEPCTION

Self –inspection shall be conducted at reasonable intervals, but should cover an area/operation/function At least once a year or if necessary at short intervals.

LIST OF ITEMS FOR SELF INSEPCTION

The   following  items  should  undergo  self-inspection  so  as  to  ensure  GMPs  in  the  premises  as  per  WHO   requirements :

1. Personnel
2. Premises  including  personnel  facilities
3. Maintenance  of  building  and  equipment
4. Storage  of  starting  materials  and  finished  products.
5. Equipment 
6. Production  and  in-process  controls 
7. Quality  control
8. Documentation
9. Sanitation  and  hygiene
10. Validation  and  revalidation  programs
11. Calibration  of  instruments  or  measurements  systems
12. Recall  procedure
13. Complaints  management
14. Labels  control
15. result  of  previous  self –inspections  and  corrective  steps  taken 

Self –inspection   program   is  conducted  in  order  to  monitor  the  implementation  and  compliance with  current  GMPs  principles  and  to  ensure  that  the  necessary  corrective measures are taken.

PROGRAMME

1. A documented  schedule is  to  be  prepared  for  program.
2. findings  must  be  reported  to  technical  director  in  writing , who should  be responsible for  the  implementation of  the  program.
3. corrective  action  must  be  implemented.

INSPECTION

1. Shall  cover  personnel ,  premises,  equipment, documentation, QC,  distribution ,    manufacturing , complaint  record  system  and  all  other  processes and  system  covered  by GMPs.
2. It  is  to  be  performed  by  technically  qualified  and  trained  personnel  having   knowledge  in plant  operation (Quality Assurance Manager , Factory Manager and  Production Executive).
3. Must  be  performed  minimally  once  in  a  year.
4. Must  be  performed  during  period  of  activity.
5.  Records  must  be  maintained  in  accordance  to  be  procedures.

CORRECTIVE ACTION

1. Should  be  appropriate  to  correct  deficiency.
2. Must  prevent  re-occurrence 
3. Must  be  completed in  a  timely  manner.
4. It  should  be  documented  and  records  maintained .
5. Must  be  monitored (following implementation of the corrective action).

SELF INSPECTION & QUALITY AUDIT TEAM