How do you record GMP activities?

GMP guidelines require thorough documentation to ensure that all manufacturing activities meet legal standards. Without proper records, it becomes challenging to prove compliance during regulatory audits or inspections. Records provide accountability and traceability, which are essential for identifying and addressing potential issues. Accurate records help ensure that products meet predefined safety and quality standards. Also, proper records are crucial for issue Identification and resolution. This aids in root cause analysis and implementing corrective actions to prevent recurrence. Records provide consistency and allow continuous Improvement. This helps in refining and optimizing manufacturing processes over time.

Nowadays GMP records are kept autometically by Electronic systems (e.g., LIMS, ERP) to ensure traceability and accuracy. Also recorded through manually via comprehensive documentation, including batch manufacturing records (BMR), standard operating procedures (SOPs), and quality control records. Key elements include production steps, equipment cleaning, environmental monitoring, and personnel training logs. Data from inspections, deviations, and corrective actions are also documented. All records are securely stored for regulatory audits and product traceability, ensuring compliance with regulatory requirements.

The reasons why we must record GMP activities are diverse: - Compliance and legal evidence of what we do and how we do it. - Product safety and quality - Ease in investigations and problem-solving Trend analysis - Because it is a regulatory requirement The integrity of the GMP records are governed under the ALCOA+ rules

Periodic Reviews of GMP records are very important. By implementing periodic reviews of GMP records, organizations can not only ensure compliance and product quality but also drive continuous improvement and foster a proactive approach to risk management.

GMP records are: - What has been done (activities/actual data/result/etc.) - Required supporting data for the above item. - Who did it (Signature with date) - Reports on GMP activities/events like deviation, complaints, change control are also GMP records.

Any type of event recording or addressing is very important. Event recording under GMP is essential for ensuring product quality, regulatory compliance, traceability, and overall risk management. It plays a critical role in maintaining the integrity of the manufacturing process.

Anything that impacts the Quality and Safety of products and therefore, a potential impact on patients must be recorded. The Quality Management System (QMS) will describe it in its manuals and SOPs.

Best practices involve the use of systematic documentation aligned with regulatory standards such as FDA 21 CFR Part 11 or EU GMP Annex 11: 1. Standard Operating Procedures (SOPs): Establish SOPs for all GMP activities, ensuring uniform documentation. 2. Electronic Batch Records (EBR): Utilize EBR systems to capture real-time data and enhance accuracy. 3. FMEA (Failure Mode and Effects Analysis): Record risk assessments and preventive measures to mitigate failures. 4. CIP (Continuous Improvement Processes): Document deviations, corrective actions, and lessons learned to refine processes. 5. Timeline Analysis: Track the sequence of events for investigations and identify gaps in GMP adherence.

GMP activities must be recorded following the ALCOA+ principles: - Attributable: linked to the person/system performing the task. - Legible: readable and understandable, even after time has passed. - Contemporaneous: at the time the activity is performed. - Original: reflect the original source of information. Modifications or additions must be traceable (manually or Audit Trail). - Accurate: free from errors and exactly reflecting what happened. - Complete: All required information, including data and metadata. - Consistent: logical order in the sequence of events, standardized formats. - Enduring: durable and maintained for the required retention period. - Available and easily accessible for audits, reviews, or investigations.

The use of computerized systems, such as ERP, LIMS, DMS, MES or EBR, will always enhance compliance in recording GMP activities, as they reduce human errors, provide traceability and reliable record keeping, secure access, audit trails, robust workflows, and allow real-time monitoring and reporting. The use of tablets and mobile devices, along with GMP-compliant apps, to collect and review data, allow real-time, point-of-use data entry and review. Printed labels or tags (barcoded or RFID-enabled) and scanners, enhance traceability, reduce errors in data entry, and ensure identification through the production lifecycle. Also, the use of electronic signatures provide accountability and traceability, which is critical for GMP compliance.

Most GMP systems use username and password combinations, but these methods pose security and efficiency risks, as credentials can be easily shared or breached, compromising data integrity. Biometric e-signatures solve this by identifying users through unique physical traits, like iris or fingerprint, eliminating the need for passwords. This ensures traceability, authenticity, and boosts efficiency by reducing authentication time. It also complies with the strictest regulations, providing top-level security without added complexity. Implementing biometrics enhances compliance and confidence in record security, eliminating risks of fraud or identification errors.

A key best practice in GMP activity recording is ensuring data integrity by adhering to ALCOA+ principles, meaning data must be attributable, legible, contemporaneous, original, accurate, and accessible. This ensures traceability throughout the supply chain and record credibility. Biometric technologies are highly effective in achieving this, as they identify employees through unique traits like the iris, eliminating risks of misidentification. Biometrics simplify processes by removing password dependency, enhancing convenience, security, and reducing vulnerabilities. Implementing biometrics ensures traceability, regulatory compliance, and boosts efficiency and reliability in GMP records.

Best practices are to follow ALCOA+ principles, as well as FDA's 21 CFR Part 11 and EU GMP Annex 11. These regulations and guidelines treat the accuracy of data recorded, legibility, real-time recording, completeness, and attributability. Best practices include proper storage of documentation to prevent damage or destruction. Also, to record training and competence, maintain data integrity, follow SOPs