OBJECTIVE:
The objective of this policy is to assure that the data produced accurately reflects the outcome of process/tests performed during manufacturing, testing, release and distribution of drug products and have been produced in bias free environment.
SCOPE:
This policy is applicable to all personnel involved directly or indirectly in current Good Manufacturing Practices activities at {Company Name} This policy is also applicable to external service providers involved in current Good Manufacturing Practices activities.
DEFINITIONS:
Data Integrity: The extent to which all data are complete, consistent and accurate throughout the data lifecycle.
Accurate: A qualitative assessment of correctness or freedom from error or magnitude of error.
Trustworthy: Ensuring data trustworthiness and reliability, as related to security of the information/data
DOCUMENTATION REQUIREMENTS:
Procedure on ‘Data Integrity and Technical Ethics Monitoring’.
Data Integrity and Technical Ethics Agreement.
POLICY
Principles
Organization provides high quality products to its customers and considers the protection of the patient as a primary guiding objective in decision making throughout the product lifecycle.
Employees who are directly or indirectly involved in current Good Manufacturing Practices activities must understand and adhere to the company’s commitment to Data Integrity, Technical Ethics and Quality Standards.
The external service providers involved in current Good Manufacturing Practices must also understand and adhere to the Data Integrity requirements.
Data Integrity requirements apply equally to manual (paper based) and electronic data.
The inherent risks to data integrity may differ depending upon the degree to which data (or the system generating or using the data) can be configured.
Breaches to Data Integrity are independently evaluated and authenticated by an Independent Data Review Group.
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/data-integrity-and-technical-ethics-policy/
Elements of Data Integrity and Technical Ethics includes:
Training on Data Integrity and Technical Ethics:
Training on Data Integrity and Technical Ethics shall be provided for employees.
The Data Integrity and Technical Ethics training shall include the need for honesty and full disclosure in all reporting and record-keeping.
The organization’s commitment to Data Integrity and Technical Ethics shall be discussed during such trainings and the trainee shall understand that breach to data integrity will be investigated and consequences of violation results in disciplinary action.
Data Integrity and Technical Ethics Agreement:
Employees shall endorse the Data Integrity and Technical Ethics Agreement.
The agreement shall state that the employees shall 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 endorsing the agreement, the senior management staffs acknowledge their duties in upholding the spirit and intent of the data integrity system and in effectively implementing the specific requirements of the policy.
External Service Providers shall also endorse a separate Data Integrity Agreement.
Data Integrity Monitoring:
Data Integrity Monitoring shall be conducted as per documented procedures. The monitoring shall be aimed at Identification, Reporting, Containment, Investigation, CAPA (including Action and Disciplinary Action), Continuous monitoring and Improvement of data integrity.
Data shall be maintained accurately and consistently over the entire data life cycle. The sources for identification of suspected breach to Data integrity shall include Routine Quality Reviews, Independent reviews, Internal Audits, External Audits and Quality Compliance Hotline.
The monitoring program shall primarily focus on review of critical systems, methods, records/data (paper based or electronic) in laboratory, manufacturing, and those associated with Non-Conformances, OOS Investigations, Complaints, FARs, etc.
Reporting of suspected breach to data Integrity:
A process nonconformance shall be initiated for any suspected Breach to Data Integrity issue as per applicable procedure.
Investigation and CAPA (including Action and Disciplinary Action):
An investigation shall be conducted on the breach to data integrity issue by a Team.
The suspected breach to data integrity issue shall be evaluated for any willful miss statement, misrepresentation, manipulation, adulteration, rewriting, hiding, replacing of quality related documents, materials, activities or equipments in order to give an item the appearance of GMP compliance or negligence or work pressure or unintentional errors.
The Independent data review group (Data Integrity Cell) shall independently evaluate and authenticate the suspected breach to data integrity, proposed actions and/or disciplinary actions and clarify the legitimate practices, where necessary.
The breach to data integrity issues shall be categorized and disciplinary actions shall be initiated, as appropriate.
The identified confirmed breach to data integrity issue shall be immediately escalated to the Data Integrity Steering Committee.
A detailed investigation shall be conducted for identifying the root cause(s) and propose corrective action to avoid reoccurrence of the issues.
Continuous Monitoring and Improvement of Data Integrity:
Monitoring shall focus on identification of control measures/improvements required to improve Data Integrity.
Recurring Breach to Data Integrity events and status of actions shall be escalated to Data Integrity Steering Committee.
The Data Integrity Steering Committee shall periodically assess the health of Data Integrity controls and monitoring tools. The committee shall provide necessary support to initiate/develop the controls and measures to improve of data integrity.
REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New policy introduced | Not Applicable | To Be Written Manual |
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/data-integrity-and-technical-ethics-policy/
