Self Inspection Check List (Personnel and Administration)

Annexure –  VII Self Inspection Check List (Personnel and Administration)

Sr. No.	Check Points	Yes / No	Remarks
General :
1	Are objective and principles of cGMP understood and applied?	Yes / No
2	Does each section have relevant standard operating procedures [SOPs]?	Yes / No
3	Are training conducted as per training programme? Check the record available and updated.	Yes / No
4	Is every person aware of company's quality policy	Yes / No
Cleaning and General housekeeping
1	Is cleaning done regularly?	Yes / No
2	Cabinet and cupboards are arranged properly.	Yes / No
3	Check the housekeeping, cleaning of followings a.         Floors, walls etc. b.         Working Table. c.         Racks.	Yes / No
Other records
1	Do you have written well defined procedure for insects, Rodents & Pest control in Place	Yes / No
2	Check if the Pest control is performed by agreement with the agency?	Yes / No
3	Do you have well defined procedure for maintaining Hygiene & Health requirements of personnel engaged in manufacturing / Processing / Packing etc.	Yes / No
4	Check if the Health records of the Personnel are maintained as per the SOP.	Yes / No
5	Are the written procedures defined for the Proper dress & sanitation responsibilities of the personnel working in factory premises?	Yes / No
6	Check that the Annual training records & Induction training records are well maintained and complete.	Yes / No
7	Is there written procedure available for: i) Collection & disposal of waste & rejected material. ii) Sewage & refuge from manufacturing area	Yes / No
8	Security system
9	Alarm system	Yes / No
10	Fire extinguisher	Yes / No
11	Safety helmets	Yes / No
12	Safety shoes	Yes / No