by - Objective
The objective of this procedure is to provide guideline for the entry and control of data in all forms of documentation in a consistent manner that provides an acceptable state of control based on the data integrity risk, and which is fully documented with supporting rationale.
2. Scope
This SOP is applicable for all controlled documentation (online/ executed), protocols, reports for processes, equipment’s in the drug product manufacturing facility.
3. Responsibility
Head and supervisors of each department.
4. Accountability
Head Quality : For system implementation.
5. Procedure:
Data integrity refers to the completeness, consistency and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).
Data integrity requirements apply equally to manual data and electronic data.
5.1 Principles of data integrity
Systems should be designed in a way that encourages compliance with the principles of data integrity and assure the data quality. Examples include:
Access to clocks for recording timed events .
All clocks within intra/ inter departments shall be harmonized for accurate recording and for the data linkups.
Accessibility of batch records at locations where activities take place so that rough data recording and later transcription to official records is not needed.
System shall be implemented for online data reporting for data to be attributable and seems to be realization.
Control over blank paper templates for data recording.
Blank papers to be used in reporting & recording of data shall be controlled & managed by Quality Assurance.
User access rights which prevent (or audit trail) data amendments.
Audit trail means a secure, computer-generated, time-stamped electronic record that allows for reconstruction of the course of events relating to the creation, modification, or deletion of an electronic record. An audit trail is a chronology of the “who, what, when, and why” of a record.
For example, the audit trail for a High Performance Liquid Chromatography (HPLC) run could include the user name, date/time of the run, the integration parameters used, and details of a reprocessing, if any, including change justification for the reprocessing.
In view of data to prevent from being lost or obscured, Electronic Audit trail systems shall be in place.
Automated data capture or printers attached to equipment such as balances
For the data to be contemporaneously (simultaneous recording), online recording devices like Printers shall be established.
Proximity of printers to relevant activities .
For the assurance of accurate relevancy of the data, recording devices shall be adhering with the system.
Access to sampling points .Accessibility to the various Sampling Points (e.g. for water systems and compressed air system) in manufacturing and utilities operation areas shall be in ease of monitoring.
Access to raw data for staff performing data checking activities.
For the assurance of data completeness, an inspection or verification checklist shall be attached.
5.2 Metadata: Metadata is structured information that describes, explains, or otherwise makes it easier to retrieve, use, or manage data.
Metadata for a particular piece of data could include a date/time stamp for when the data were acquired, a user ID of the person who conducted the test or analysis that generated the data, the instrument ID used to acquire the data, audit trails, etc.
For eg. In reference of any weight for a reagent, following practices shall be followed:
Date /operation time/used for/ batch No. / Sign. of analyst or operator.
5.3 Archive:
Long term, permanent retention of completed data and relevant metadata in its final form for the purposes of reconstruction of the process or activity.
Archive records shall be locked such that they cannot be altered or deleted without detection and audit trail.
5.4 Backup:
A copy of current (editable) data, metadata and system configuration settings (variable settings which relate to an analytical run) shall be maintained for the purpose of disaster recovery.
There shall be a standard procedure for taking back up of all electronic data from individual instrument/equipment.
5.5 Falsification and misrepresentation of documents/data:
In case of any falsification, misrepresentation of documents/data, immediate corrective action shall be taken by the concerned employee, his / her department head and the divisional head, if required. The divisional head shall initiate necessary steps to prevent such instances in future.
Falsification and misrepresentation of the documents / data shall be considered as an offence.
Any employee involved directly or indirectly in writing, issuing or approving false documents / data or misrepresentation of documents / data shall be liable for the punishment.
The nature of punishment shall be at the discretion of the Management ranging from a Warning letter to the termination of the services depending upon the nature and severity of an offence.
5.6 Investigation after a falsification / misrepresentation occurred:
Upon the discovery that falsification and / or misrepresentation of documents / data occurred the Head of the department shall initiate an investigation to determine the depth of the infraction and the impact on product quality.
If the misrepresentation was determined to be intentional and not a one time error, the activities performed by the infringing individual one month before and one month after the incident occurred shall be investigated.
The investigation shall be extended to cover a longer period if the investigation in the first phase revealed additional infractions/deviations. This investigation shall cover a maximum period of three months from the date of the second infraction/deviations.
The Head of the department where the infraction/deviations occurred, the Head Quality Assurance / Head Operations and the head Quality shall determine the impact of the deviation on the quality of the product. If the product quality was compromised, they shall initiate an appropriate corrective action.
6. TRAINING
Trainer : Head – Quality Assurance
Trainees : Staff of all the departments
7. DISTRIBUTION
Master Copy : Quality Assurance
Controlled Copy : Quality Assurance
8. ATTACHMENT
Nil
9. REFERENCE
In-house
10. Abbreviation
| Abbreviation | Extended Form |
| EG | Engineering |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| WH | Warehouse |
| NA | Not Applicable |
| MB | Microbiology |
