Your Guide to Achieving GMP Excellence
Recall Records Recall records are documents that capture information related to the recall of products from the market due to safety concerns, quality issues, or regulatory non-compliance. These records document the entire recall process, including initiation, communication, retrieval, and resolution of recalled products. Key Components of Recall Records: Reason for Recall: Explanation of the reason…
Distribution Records Distribution records are documents that track the movement of products from the manufacturer to the end user or consumer. These records are essential for ensuring the proper handling, storage, and delivery of goods to maintain their quality and integrity throughout the distribution process. Key Components of Distribution Records: Product Details: Information about the…
Training Records Training records are documents that track the training activities of employees within an organization. These records capture details of training programs attended, skills acquired, and certifications obtained by employees. Training records are essential for ensuring compliance, assessing competency, and promoting professional development. Key Components of Training Records: Employee Information: Details of the employee…
Self-inspection reports are documents that detail the findings and outcomes of internal evaluations conducted by organizations to assess their compliance with regulations, quality standards, and best practices. These reports help identify areas for improvement, ensure adherence to guidelines, and maintain high standards of quality and safety. Key Components of Self-Inspection Reports: Scope of Inspection: Description…
Product Quality Review Reports are comprehensive evaluations of pharmaceutical products conducted periodically to ensure consistency, compliance, and continuous improvement. These reports assess the quality of products, processes, and systems to identify trends, highlight areas for improvement, and maintain product quality standards. Key Components of Product Quality Review Reports: Review Scope: Overview of the products and…
Complaint records are documents that capture information related to customer complaints, product defects, or quality issues in regulated industries. These records are used to track, investigate, and address reported concerns to ensure customer satisfaction and product quality. Key Components of Complaint Records: Complaint Details: Description of the complaint, including the nature of the issue and…
Deviation reports are documents that detail any departures from established procedures, specifications, or standards during the execution of processes in regulated industries. These reports document deviations, investigate root causes, and propose corrective and preventive actions to prevent recurrence. Key Components of Deviation Reports: Deviation Description: Explanation of the deviation, including when and where it occurred….
Change control records are documents that track and manage changes made to processes, systems, equipment, or facilities in regulated industries. These records provide a systematic approach to evaluating, documenting, and implementing changes to ensure compliance, quality, and safety. Key Components of Change Control Records: Change Request: Description of the proposed change, including the reason and…