GLP Compliance - Center for Biopharma Analysis

CBA facility is set up as a GLP compliant facility to offer high quality analytical characterization services. The processes are devised following the OECD guidelines. CBA will soon be submitting an application for GLP certification to NGCMA.

This checklist is meant to provide a quick look at the GLP compliant processes followed at CBA.

S. No.	Requirement	Yes/In progress
Organization and Laboratory Personnel
1	Does an organizational chart exist for CBA?	Yes
2	Is there a training and evaluation plan for all personnel aligned to the job description?	Yes
3	Have personnel received health/safety training?	Yes
4	Is there a process to report incidents and deviations?	In progress
5	Are external Vendors qualified before engagement?	Yes
Quality Assurance Program
6	Is there a Quality Assurance Unit?	Yes
7	Is the Quality Assurance Unit independent from the personnel engaged in the study?	Yes
8	Does the Quality Assurance Unit perform audits and report the results to the Laboratory Management?	In progress
Standard Operating Procedures
9	Is there a current index listing of the SOPs available?	Yes
10	Is there a schedule for review of the SOPs?	Yes
11	Are the SOPs in locations where they are used?	Yes
12	Are there SOPs for reporting deviations and CAPAs?	Yes
13	Is there a change control system for SOP/methods?	Yes
Facility
14	Is the access control to the facility?	Yes
15	Is there sufficient segregation between areas marked for storage of chemicals, archiving records, equipment, and sample preparation?	Yes
16	Is there a system to code test samples and reference samples and prevent cross contamination?	Yes
17	Is there safety equipment (e.g., showers, eyewash stations) available? Is the safety equipment maintained?	Yes
18	Are there environmental controls within the laboratory and are the controls monitored?	Yes
19	Is there a power back up provision at the facility?	Yes
Equipment
20	Are the equipment uniquely identified with a defined identification number?	Yes
21	Are the equipment manuals and SOPs available for ready reference?	Yes
22	Are there log books for each equipment that include a chronological record of use?	Yes
23	Equipment calibration and/or preventative maintenance schedules have been established and are being followed and documented	In Progress
24	Is system access limited to authorized individuals only?	Yes
Documentation
25	Are Good Documentation Practices followed?	Yes
26	Is raw data recorded in lab notebooks or electronically and is controlled?	Yes
27	Is there a SOP that outlines the content of the final report?	Yes
28	Is there a dedicated facility/area for the archival of records?	Yes
	Is there a method of electronic data archive?	In progress
Samples/Reagents/Chemicals/ Methods Control
29	Is the sample receipt area maintained separate from the sample processing area?	Yes
30	Is there an SOP that outlines how reagents are labelled, how expiration dates are established?	Yes
31	Are there validated methods and acceptance criteria for each test method?	In progress
Computer Systems
32	Are changes to computer systems controlled and documented?	In progress
33	Are records of hardware maintenance and repairs maintained?	Yes
34	Are computers backed up routinely to prevent loss of data? Is there a backup log?	Yes
35	Are there a computer validation master plan and/or SOPs?	In progress

References:

The OECD Principles of Good Laboratory Practice (as reviewed in 1997), No. 1, OECD series on Principles of Good Laboratory Practice and Compliance Monitoring (ENV/MC/CHEM (98)17).
International Organization for Standardization. (2017). ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories. (NABL certification)
http://www.mcrhrdi.gov.in/drugs/checklist/Schedule%20%20L%201%20-Final.pdf