Procedure For action to be taken during spillage /breakage of materials

1.0    OBJECTIVE

• To lay down procedure for action to be taken during spillage /breakage of materials.

• SCOPE

2.1   This procedure is applicable to Warehouse and Quality Control departments for equipment cleaning and operation at pharmaceutical company.

• RESPONSIBILITY
  • Warehouse Chemist concerned department – To clean equipment after use and to operate equipment carefully.
  • Officer/Executive-IPQA- To verify cleaning operation and collection of sample at defined intervals, wherever applicable.
• ACCOUNTABILITY
  • Manager-Warehouse
  • Manager-Quality Assurance
• PROCEDURE

    5.1        For Solid Material / Waxes

5.1.1     If any spillage / breakage is occurred, Store person shall segregate or shift other surrounding materials to avoid contamination.

5.1.2     Store person shall intimate to QA person about the incidence for corrective action.

5.1.3     With the help of vacuum cleaner or nylon broom, spilled material shall be collected by Store person by taking sufficient safety precautions before cleaning the area (i.e., wear safety goggles, nose mask, hand gloves, safety shoes etc.).

5.1.4     Transfer the contents of affected container or bag to another good and cleaned container or bag (if possible).

5.1.5     Weigh and note the quantity of the spilled material and destroyed as per SOP in presence of QA person. With approval of HOD QA/QC and Unit Head, and the same   Qty is to be deducted from the SAP and from respective bin-card.

5.1.6      Note the cause of accident and take appropriate corrective action to avoid recurrence of such incident.

5.2    For Liquids Materials like oil / acids 

5.2.1 For oil spillage or leakage, cover the area with the help of dry sand to avoid further spread out.

5.2.2 With the help of nylon broom, collect the affected sand and discard in a waste bin which further disposed off in a ETP.

5.3    For Solvent

5.3.1 In case of spillage or leakage of solvent, immediately open the windows and doors (if possible) for proper ventilation.

5.3.2 Store person shall restrict the area for minimum man movement.

5.3.3 Mop the area as per the SOP with all safety precautions like wearing nose mask and safety goggles and discard the spilled solvent in the ETP.

5.3.4      Transfer the contents of affected container or drum to another good and cleaned container or drum (if possible).

5.3.5      Weigh and note the quantity of the spilled material and destroyed as per SOP in presence of QA person.

5.3.6      With approval of manager QA/QC and Unit Head, and the same Qty is to be deducted from the SAP/laser or respective system.

5.3.7      Note the cause of accident and take appropriate corrective action to avoid recurrence of such incident.

• ABBREVIATIONS

6.1    SOP      –   Standard Operating Procedure.

6.2   QA        –   Quality Assurance.

7.0    FORMAT

8.0    DISTRIBUTION LIST

Procedure for review, audit and storage of batch records and testing records