sop for data integrity
OBJECTIVE
The purpose of the Data Integrity Standard Operating Procedure (SOP) is four-fold:
1.1.1 To describe the laboratory’s data integrity system,
1.1.2 To emphasize the paramount importance of ethics in the performance of all analytical work,
1.1.3 To obtain the commitment of laboratory staff to the principle that all analyses shall be performed in a controlled and documented manner, and
1.1.4 To ensure that laboratory staff consistently meet the specific ethical requirements defined in this data integrity plan.
SCOPE
This procedure applies to all analyses and activities performed within the laboratory and various activities performed in Production, Store, Human Resource, IT, Maintenance and Quality Assurance Department at
RESPONSIBILITY
Head Quality Assurance:
3.1.1 To support and provide initial data integrity training and on-going annual training to all departmental heads and staff.
3.1.2 To ensure that only staff who sign the ethics agreement are allowed to work in the department.
Head HR:
3.2.1 To prepare and maintain the ethics agreement of each employee.
Quality Assurance Officer & IT Officer:
3.3.1 To perform in-depth review of laboratory reports and the data used to support them on a monthly basis.
3.3.2 To perform in-depth review of Production, HR, IT, Store, Maintenance and QA Department on monthly basis.
3.3.3 To prepare a summary of plan updates, on-going ethics/data integrity training and data integrity investigations to the senior management. The summary shall cover the time period since the last on-site assessment
3.4 Senior Management:
3.4.1 To review summary of plan updates, on-going ethics/data integrity training and data integrity investigations provided by QA Officer and IT Officer.
3.4.2 To take actions on employee who is not following the specific ethical requirements defined in this data integrity plan.
ACCOUNTABILITY
4.1 Department Head
4.2 Head Quality
PROCEDURE
5.1 Ethics Training:
5.1.1 Ethics training is a required part of new employee orientation.
5.1.2 Ethics training to be provided on an annual basis for all staff by respective Head of Department. Initial training during orientation includes the overall organizational mission and its relationship to the absolute need for honesty and full disclosure in all analytical reporting and record-keeping.
5.1.3 The initial orientation to be immediately followed-up by respective Head of Department/Designee with the specifics of the data integrity plan. Examples are described that illustrate unethical behavior and ethical behavior related to laboratory data/other activities data manipulation.
5.1.4 The organizations response to infractions of the data integrity plan will be discussed and the trainee shall understand that infractions will be investigated in a detailed way. The consequences to an employee found to be in violation of the data integrity plan may result in immediate termination, debarment, and/or civil/criminal prosecution. Confidentiality is assured during this process.
5.2 Ethics Agreement:
5.2.1 Following initial ethics training, employee shall sign a written ethics agreement. HOD of respective department and HR Head shall also sign the agreement. The agreement states that the signers will not engage in any unethical practices with respect to data integrity nor will they tolerate improper behavior in others if it is observed or suspected. By signing, HOD acknowledge their duties in upholding the spirit and intent of the data integrity system and in effectively implementing the specific requirements of the plan.
Monitoring:
Data integrity review schedule to be prepared by QA covering all departments and accordingly data integrity to be verified in coordination with IT Officer.
The purpose of the review is to verify that all data integrity requirements are met. Therefore the QA Officer and IT Officer
shall have an in-depth understanding of typical inappropriate analytical behavior and be trained in the data integrity system
Data integrity review:
5.3.3.1 Reports and the data used to support them are randomly selected by the Quality Control Officer and IT Officer for auditing. Quality Assurance Officer and IT Officer to audit 5 % or 5 data packages, whichever is more in every month of all department.
5.3.3.2 In QC, unknown reference samples may be submitted for analysis as real samples by the QA Officer,
(Unknown to the analyst) as part of any project or event Data and results of the reference sample are reviewed by the QA Officer to verify that all data integrity requirements are met.
QA Officer and IT Officer to discuss the data integrity review findings with Head of respective department and Head QA. QA Officer and IT Officer to prepared data integrity report as per Format No.: for ‘Data integrity review report’ and the same shall be forwarded to concerned department, Head QA and senior management.
All data integrity incidents to be documented, including investigative findings as per SOP No.: for “Handling of Non-compliance”. Corrective and preventive actions to be taken as per SOP No. for “Corrective Action and Preventive Action”. Based on the root – cause identified, Senior Management in coordination with concerned HOD and Head QA shall take action on employee who is not following the specific ethical requirements defined in this data integrity plan.
Note: Agreement from each individual employee for Data Integrity Ethics shall be taken by HR department after induction training. Refer Format No.
TRAINING
6.1 Trainer – Head-Quality.
6.2 Trainee – All Concern Person.
6.3 Period – One hour or as per required.
DISTRIBUION
7.1 One set of master copy & controlled copy submitted the quality assurance department.
ENCLOSURE
8.1 Data Integrity Review Report
8.2 Data Integrity Review Schedule
8.3 Data Integrity Agreement
ABBREVIATIONS
9.1 SOP : Standard Operating Procedure
9.2 QA : Quality Assurance
9.3 QC : Quality Control
9.4 HR : Human Resource
9.5 IT : Information Technology
9.6 MS : Maintenance
9.7 WH : Warehouse
9.8 HOD : Head of Department
DOCUMENT CHANGE HISTORY
| Revision | Reason for Revision | Effective Date |
| 00 | New SOP |
DATA INTEGRITY REVIEW REPORT
| Sr. No. | Data Checked | Personnel involved in activity | Observation |
|
|
DATA INTEGRITY AGREEMENT
Employee Name:
Designation:
Employee Code:
Date of Joining:
I hereby declare that data integrity requirement of ABC Pvt. Ltd. is explained to me and I shall follow it strictly.
- I will not share company’s confidential data during and after my service.
- I will not share my password, log in ID with any one.
- All data entry will done timely.
- I will not alter any data for its accuracy and correctness.
- I shall follow specification and SOP strictly.
- I will not manipulate equipment and instrument to get the desired results.
- I will bring into the notice and supervisors if any discrepancy observed.
Sign/Date:
Online Rejection in parenteral
Receipt of Batch from Production to Packing Department
sop for for Spillage Handling in parenteral area
sop for calibration of vessels with dipstick
sop for Cleaning of Bins and Containers
cip of mixing vessel and holding vessel
sop for Cleaning of Ampoule Filling and Sealing Machine
sop for Fogging in Sterile and Non Sterile Area
sop for for Filtration of Bulk Solution
sop for fumigation in production area
sop for post cleaning after media fill
sop for cip of mixing vessel mixing mobile vessel and holding vessel
sop for De-Bagging of Three Piece Vial Dropper Caps
sop for calibration and verification of check weigher
sop for Batch number and Manufacturing and Expiry Date Coding System
standard operating procedure machine history file
sop for operation and cleaning of Hand coder
sop for Cleaning and Handling and Silicone Tubes
sop on operation and cleaning of coating pan
sop for Operation of cleaning of pipe lines
sop for operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
sop for monitoring of reprocessing of products
sop for in-process control on liquids orals
sop for in process controls on tablets capsules packaging line
sop for Issuance retrieval and destruction of BMR and analytical records
sop for in process controls during granulation compression coating inspection
sop for Cleaning of Blister packing machine
sop for for charge hand over between the shifts
Performance requalification report of visual inspectors
sop for Cleaning and operation of ROPP caps inspection table
sop for usage and destruction of filter pad and cartridge filter
sop for cleaning and storage of transfer pipe
sop for Cleaning and operation of labeling machine
Cleaning and operation of the mono block filling and sealing machine
sop for Cleaning and operation of empty bottle inspection table
sop for Cleaning and operation of filter press
sop for cleaning and operation of liquid transfer pump and line
sop for cleaning and operation of storage vessels
sop for cleaning and operation of sugar syrup manufacturing vessel
sop for cleaning issuance and retrieval of accessories and change parts
sop for Cleaning and operation of visual inspection conveyor belt
sop for Cleaning and operation of spray gun and assemble
sop for Fogging in Aseptic and Non Aseptic Area