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: | |
Sr. No. | Questions | Yes | No | Comments |
3.3 | Do you have a written training program for analysts? | |||
3.4 | Does your training program include the following? | |||
GLP | ||||
GMP | ||||
Job training | ||||
Safety and Environmental issues | ||||
ISO principals | ||||
3.5 | Is the 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 the laboratory? (Attach a list of Instruments) | |||
4.2 | Is the SOP of all instruments present? | |||
4.3 | Is the 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 |
ALSO READ: Importance of Supplier Quality Questionnaires
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 a copy of the certificate) | ||||
6.0 | QUALITY ASSURANCE | |||
6.1 | Is there a system for the rejection of samples? | |||
6.2 | Do you have specifications approved by QA for the working/reference standards of the product? | |||
a. For Physical, Chemical requirements | ||||
b. For Microbiological requirements | ||||
6.3 | Is there a 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 methods for evaluation? | |||
Total sample received | ||||
No. of samples passed | ||||
No. of samples 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 | ENVIRONMENT MANAGEMENT SYSTEM: | |||
7.1 | Do you have any environmental policies? |
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 the 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? |
