Problem Overview
A Good Laboratory Practice (GLP) Laboratory faced significant challenges that were highlighted during a major finding by the Medicines and Healthcare products Regulatory Agency (MHRA). The finding revealed a crucial issue within the laboratory’s Standard Operating Procedure (SOP) system, indicating that it was not under the appropriate control. This was evidenced by a staggering 79% of SOPs being outside of their review cycle of 24 months as required by the local SOP. A GLP Laboratory review performed by The Knowlogy pinpointed deficiencies with the document management process, including:
- SOPs not approved by Test Facility Management or a designated individual.
- Distribution of ink signed SOPs instead of copies of the original SOP.
- Post-dated signatures on SOPs.
- Lack of evidence for QA Review.
- Uncontrolled forms and templates as described in the SOP.
- Management of forms not meeting the OECD No. 22 Section 6.2 requirements.
Solution Implementation
The GLP Laboratory took decisive actions to address the deficiencies identified:
Review and Management of SOPs
- Periodic Review: A comprehensive review of all SOPs due for periodic review was completed in 2022, setting the next review cycle by the end of 2024. SOPs from each department were selected for quarterly reviews to evenly distribute the workload throughout the year.
- Delegated Approval: The job description was updated to delegate the approval of department-specific SOPs to appropriately qualified individuals, ensuring proper authorization.
SOP Distribution and Control
- Master SOP and Copies: Training was provided to the SOP Controller to create a master ink-signed original SOP, with photocopies distributed to departments.
- Effective Date Policy: The effective date on SOPs was changed to “1 week from the approval date” allowing adequate time for distribution before becoming effective.
- Identification of Controlled Copies: Controlled copies were made on colored paper to distinguish them from printouts or originals.
Quality Assurance and Electronic Management
- QA Review Evidence: Email correspondence and the electronic SOP with QA track changes/comments were retained electronically as evidence of QA review.
- Control of Forms and Templates: New mechanisms and processes were designed to control Forms and Templates in compliance with OECD No. 22 requirements. This included protecting electronic versions to prevent unauthorized changes and conducting risk assessments for the controlled issue of forms, addressing suitability concerns for the facility.
Outcome and Impact
The implementation of these solutions significantly improved the GLP Laboratory’s documentation control system, ensuring compliance with MHRA requirements and OECD guidelines. The laboratory’s proactive approach not only addressed the immediate issues but also set a precedent for maintaining high standards in laboratory practices. By spreading SOP reviews throughout the year, the laboratory ensured continuous compliance and minimized the risk of future findings related to SOP control.
This case study exemplifies the importance of robust documentation control in maintaining GLP compliance and highlights the effective strategies that can be employed to overcome challenges in this area. The GLP Laboratory’s commitment to quality and compliance serves as a model for other laboratories facing similar challenges.
GLP Lab Overhauls Documentation Control After MHRA Audit
Non-compliance sting: A GLP lab faced a critical finding during an MHRA audit, exposing systemic issues within their SOP system. A staggering 79% of SOPs languished beyond their 24-month review cycle, compounded by:
- Unapproved SOPs: Missing signatures from Test Facility Management or designated individuals.
- Uncontrolled Distribution: Ink-signed originals distributed instead of controlled copies.
- Time Distortion: Post-dated signatures on SOPs raising red flags.
- QA Review Mirage: No documented evidence of Quality Assurance review.
- Form Frequency: Uncontrolled forms and templates deviating from SOP guidelines and OECD No. 22 Section 6.2 requirements.
Proactive Response: The lab took decisive action to rectify these non-compliance issues:
- SOP Overhaul: A comprehensive review of all overdue SOPs was completed in 2022, with the next cycle set for 2024. Quarterly reviews were established for each department, distributing the workload evenly.
- Delegated Authority: Job descriptions were updated to delegate approval authority for department-specific SOPs to qualified personnel, streamlining the process.
- Controlled Copies: Training equipped the SOP Controller to create master, ink-signed originals. Photocopies were distributed to departments for controlled use.
- Effective Date Enforcement: The effective date on SOPs was revised to “1 week from approval date” to ensure proper distribution before implementation.
- Color-Coded Control: Controlled copies were printed on colored paper for clear differentiation from printouts or originals.
- QA Evidence Trail: Email correspondence and electronic SOPs with QA track changes/comments were electronically archived for robust review documentation.
- Content control: New mechanisms and processes were implemented to control forms and templates in accordance with OECD No. 22 requirements. This included:
- Electronic version protection from unauthorized modification.
- Risk assessments for controlled form issuance.
- Addressing suitability concerns for the facility.
These improvements significantly bolstered the lab’s documentation control system, guaranteeing adherence to MHRA regulations and OECD guidelines. Their proactive approach not only addressed the immediate audit findings but also instilled a culture of continuous compliance. Spreading SOP reviews throughout the year minimizes future non-compliance risks.
For more information on how we can help your laboratory achieve and maintain compliance with GLP standards, contact us.