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Contract Laboratory Approval Questionnaire


Sr. No.

Questions

1.0

GENERAL INFORMATION

1.1

Name and Address of Laboratory:

1.2

Contact Person:

Name:

 

Phone No.:                      Mobile No.:                     E-mail ID:

2.0

FACILITIES:

Please specify what type of analysis you are performing?

3.0

PERSONNEL:

3.1

Number of Staff:

No.

Director(s)/ responsible person of the organization:

Head/ Responsible person for Analysis:

 

Q A:

Q C:

R & D Lab:

Microbiology:

Others:

3.2

No. of Approved persons:

 


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Sr. No.

Questions

Yes

No

Comments

3.3

Do you have a written training program for analyst?

3.4

Does your training program include the following?

GLP

GMP

Job training

Safety and Environmental issues

ISO principals

3.5

Is efficiency of training regularly checked?

By examination

By any other relevant process

3.6

Are there written job descriptions for all employees?

4.0

INSTRUMENTS AND CALIBRATION:

4.1

Is there an approved preventive maintenance program for all equipment used in laboratory?

(Attach a list of Instruments)

4.2

Is SOP of all instruments present?

4.3

Is SOP of calibration of all instruments present?

4.4

Are all instruments properly calibrated and labeled?

4.5

Is there a calibration calendar maintained?

5.0

QUALITY MANAGEMENT:

5.1

What is your QA System based on?

GMP

cGMP

USFDA

ISO 9001:2000

5.2

Are you regularly inspected?

By clients

By National authority

By Foreign authority

By FDA

 

 

Sr. No.

Questions

Yes

No

Comments

5.3

Does your Laboratory have GMP/ USFDA /cGMP/ ISO approval? If Yes specify

Name of authority         Date of Certificate

 

 

 

(Attach copy of certificate)

6.0

QUALITY ASSURANCE

6.1

Is there system for rejection of sample?

6.2

Do you have specification approved by QA for working/reference standards of the product?

a.      For Physical, Chemical requirements

b.      For Microbiological requirements

6.3

Is there procedure for sample handling and its inspection regarding?

Name of customer

Sample quantity

Batch No.

Date

Product related to Pharmacopoeia

6.4

Do you use statistical method for evaluation?

Total sample received

No. of sample passed

No. of sample failed

6.5

Do you have all documented procedures for each and every step?

6.6

Are there validated:

Analytical procedure?

Cleaning procedure?

7.0

ENVIROMENT MANAGEMENT SYSTEM:

7.1

Do you have any environmental policy?

 

 

Sr. No.

Questions

Yes

No

Comments

7.2

Do you have ISO 140001 certificate?

(Attach copy)

7.3

Do you check the environmental conditions of laboratory regarding?

Temperature

Relative Humidity

8.0

WATER:

8.1

Which type of water used for analysis?

8.2

How will you check the quality of water and it is free of contamination?

 

 

Questionnaire filled by:

Name

Signature and stamp of company

 

Designation

Date:


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