Quality Assurance

OPENING AND CLOSING OF THE DEPARTMENT

OPENING AND CLOSING OF THE DEPARTMENT

PROCEDURE

Opening of department

Collect the keys from the security gate and enter the detail in register.

Switch on the lights located at the entry of the department.

Check that the seal on the main door of the department is intact & only then open the department. (If applicable)

Keep the main key at designated place & collect other keys of different area.

Open each section of the department. Switch on the lights.

After opening of each area, keep all the keys respectively at designated place.

Intimate to maintenance department for air handling unit starting.

Early in the morning before the day’s work starts, the warehouse shall be check the daily record for department cleanliness and also check all warehouse area visually, any abnormal observations or deviations must be given in writing to the plant head.

Closing of the department

Switch OFF the exhaust system of the department.

Switch OFF the switches of all the equipment.

Check that the water taps are closed properly (if applicable).

Check that the compressed air valves are closed properly & indicator shows 0 reading (if applicable).

Check that all balances are switched OFF.

Switch OFF all the lights of cubicles.

Switch of the computer.

Intimate Maintenance department to switch OFF AHU.

Lock all internal room and keep the all keys at designated place

Lock the department.

Switch OFF the lights located at the entry of the department.

Opening and Closing of Finished Goods Store

Collect the main key of door from the internal keyboard of the department.

Check that the seal on the main door of the finished goods store is intact & only then open the department other than immediate inform to plant head for necessary action.

Switch on the lights located at the department.

Take the main key of the department and lock the door.

Seal the door.

Switch OFF the lights located at the department.

Hand over the keys at the department head.

Alvina

Alvina is the Author and founder of Guidelinepharma, she is a pharmaceutical professional having more than 20 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, and Nectar life Science Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube