SELF-INSPECTION

STANDARD OPERATING PROCEDURES FOR SELF-INSPECTION

1-     PURPOSE:

Self-Inspection is conducted to inspect the Production Premises, The process including production and Quality Control and its compliance with Good Manufacturing Practices.

2-     RESPONSIBILITY:

The management is over all responsible to do the arrangements for self Inspection and other requirements but the responsibilities may be assigned to the Plant Manager.

3-     SELF INSPECTION TEAM:

The team responsible for Self Inspection shall consist personnel who can evaluate the implementation of Good Manufacturing Practices. The team members for Self Inspection are:-

3.1     Chief Executive.

3.2     Plant / Production Manager.

3.3     Quality Assurance / Quality Control Manager.

3.4     One director of the Company.

3.5     Accounts officer / Accountant.

4.   ITEMS FOR SELF- INSPECTION

      All main items of the Production, Quality Control and premises including building , will be inspected as per Good Manufacturing Practices requirements but the inspection standard / parameters will be decided mutually before the inspection is started. The main items for Self Inspection are as follows:

4.1          Personnel and their Hygiene;

4.2          Premises and including Personnel Facilities;

4.3          Maintenance of Buildings and Equipment;

4.4          Storage of Starting Materials and Finished Products;

4.5          Equipment and their Calibration;

4.6          Production and In-Process control procedures;

4.7          Quality Control facilities;

4.8          Documentation and Records

4.9          Sanitation and Hygiene (plant and personnel);

4.10      Validation and Verification program;

4.11      Calibration of Instruments or Measurement Systems;

4.12      Recall Procedures;

4.13      Complaints Management;

4.14      Label Control;

4.15      Results of previous Self-Inspection and any corrective steps taken.

5.  FREQUENCY OF SELF-INSPECTION:

     The frequency of Self- Inspection may be changed as per requirements, but normally it will be conducted on monthly basis.

6. PROCEDURES:

6.1     The management will call a meeting of the Self Inspection Team and the relevant personnel, where the program / schedule will be decided. The Management Coordinator will inform in writing, all the members and get their signatures.

6.2     The Self Inspection may be called on specials occasions like

6.2.1       Short Comings in GMP implementation and other processes.

6.2.2       Product Recalls.

6.2.3       Repeated Rejection in Production.

6.2.4       Addition of a New section in existing premises.

6.2.5       Inspection by the Central Licensing Board is expected/required.

6.3     A written Questionnaires will be provided to Each Member of the Team.

Each member has only to tick the relevant column.

  7. SELF INSPECTION REPORT:

The Coordinator shall collect the individual report from each member and a detailed report of Self Inspection will be prepared. The main Item of the report shall be.

7.1     Self Inspection Results (Previous)

7.2     Evaluations and Conclusions.

7.3     Recommended Corrective Action.

8. FOLLOW UP ACTION:

8.1  The Company Management shall call a meeting of the Department Heads to evaluate the Self Inspection report.

8.2    The Deficiencies / Shortcoming will be noted and the procedures to Rectify shall be discussed / decided.

8.3     A personnel from the management will be appointed to follow up the rectification program.

8.4     After a specified period, the responsible person will submit a detailed rectification program.

8.5     The Dates and Times for next routine inspection will be decided after rectification report.

8.6      The Inspection Remarks given by each member will be followed on priority basis.