CHAPTER 3

PREMISES

GENERAL CONDITIONS

REF:

WHO 32

YES

NO

1

Section

11.1

Is the building exterior in good conditions?

2

Section

11.2.

Are there any sources of environmental contamination in the area surrounding the building?

2.1

Section11.2

If "YES", are protective measures undertaken?

3

Section

11.2.

Are the free and non productive areas belonging to the company in good clean and orderly conditions?

4

Section

11.2.

Are the roads leading to the building tarred and/or built so that dust from the road is not a source of contamination inside the plant?

5

Section

11.6

Is there any protection against the entry of rodents, insects, birds and other animals?

6

Section

14.46(f)

Is there a written pest control program with its respective records?

7

Section

14.46(f)

Is there a SOP for pest control?

7.1

Does the SOP indicate the substances used for pest control?

7.2

Does the Regulatory Authority authorize the used substances?

8

Section

4.1

Does the SOP ensure the avoidance of contamination of starting materials, packaging materials, in process-products and finished products with rodenticides and/or fumigant agents?

REF:

WHO 32

PREMISES

GENERAL CONDITIONS

YES

NO

9

Sections

11.1;11.2

And 11.21

Is the flow of personnel and materials such that they prevent product contamination?

10

Are corridors free of in-transit materials?

11

Sections

11.5 and11.26

Are air conditioning and/or ventilation systems for each area in accordance with the operation to be carried out?

12

Section11.5

Are visible electric installations in good conditions?

13

Section

12.4.

Are water, gases, electricity, steam, compressed air and other gas pipelines identified?

14

Does the company comply with the national legislation on fire control and prevention?

15

Sections

13.38

13.39

Are there SOPs for waste classification and treatment?

Are they followed (or complied with)?

16

Sections

13.38 and

13.39

Is waste treatment undertaken in the premises?

16.1

Sections

13.38 and

13.39

If "YES", is there a specific area for waste treatment, completely separated from manufacturing areas?

REF:

WHO 32

ANCILLARY AREAS

YES

NO

1

Section11.8

Are there general change rooms in the plant?

2

Section

11.8.

Are toilets, change rooms and showers separated from manufacturing areas?

 Are they of easy access, and in good condition with respect to cleanliness, sanitation, order and conservation?

 Are they adequate for the number of users?

3

Section

11.7

Are the dining room, social areas and cafeteria (rest and snacks) separated from production areas?

4

Sections

10.21 and

10.23.

Are plant staffs (temporary and permanent) provided with proper working clothes for each area, including protective coverings to avoid direct contact with products and to protect themselves?

5

Are there SOP’s for washing uniforms separately depending on the type of area (sterile, non sterile, maintenance, special products)?

6

Is there a laundry area for uniforms which is separate from production areas?

7

If an outside laundry facility is used, are personnel and the person responsible instructed about the corresponding SOP?

7.1

Are there instruction records?

7.2

Is this outside laundry facility periodically audited?

7.3

Are there audit records?

REF:

WHO 32

MAINTENANCE

YES

NO

8

Section

11.9.

Are the maintenance areas physically separated from production areas?

9

Is there a SOP of the use, cleaning and maintenance of different service generated equipment?

10

Are there preventive maintenance programs for equipment and critical support systems?

Are performance records for this preventive maintenance program kept?

11

Sections

18.18 and

12.11

Is equipment identified as out-of-service or in reparation identified as such?

 Are they removed from production areas as soon as possible?

12

Section

14.46 (c)

Is there a preventive maintenance program for the premises?

Are there performance records for this preventive maintenance program?

13

Section

14.47 (c)

Are records of the usage of critical equipment showed?

14

Section

12.1

Is there a preventive maintenance program for quality control equipment?

Is there a performance record for this preventive maintenance program?

REF:

WHO 32

GENERAL SERVICES

YES

NO

15

Section 15.11

Is there a pure steam generator, if necessary?

16

Section

15.11

Is there a compressed air generator free of oil, if necessary?

17

Sections

15.17

Is there an electricity generator for the maintenance of critical systems and processes to be used in case of problems with the electricity supply occur?

18

Section

11.2

Are the system generators for different services separated from production areas?

19

Do they use gases that will be in direct contact with products?

19.1

Are gas piping and valves in good conditions and are they dedicated for each gas?