The purpose of this SOP is to define the procedure for review the draft BMR and BPR prior to final approval. Also this SOP shall be applicable for review of executed BMR/BPR prior to final release of batches.
This standard operating procedure (Change Control Procedure) defines the requirements to ensure changes to systems (including equipment and utilities), products, processes, procedures, and documents that could impact product quality/compliance are evaluated, documented, and approved prior to implementation and closure.
This Standard Operating Procedure (SOP) provides the requirements for identification, evaluation, implementation, effectiveness monitoring, closure, and documentation of Corrective Actions and Preventive Actions (CAPA). The CAPA system is designed to address continuous improvement of Quality Systems.
This procedure is applicable for the different types of training as listed below: Induction training Job-specific department training Unplanned training On the-Job Training (OJT) Classroom Training External training Retraining This SOP covers training activities for personnel, whose roles and responsibilities could affect the SISPQ of the Product.
This SOP is applicable for deviation/incidents from cGxP, approved specifications and/or any established procedures including but not limited to Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), Breakdowns, facilities, storage, distribution, manufacturing, testing, packaging, warehouse and distribution of drug products intended for use in humans, as well as drug substances.
To define the procedure for carrying out internal audits (Self-inspection) for systemic examination of quality systems and processes to verify compliance with applicable regulatory cGMP requirements, to improve the system and to determine the effectiveness in meeting specified objectives.
This SOP (Master Batch Record) applies to Master Batch Records for biological products, drug substances, drug products, bulk products, intermediates, and medical devices for which specific requirements must be enumerated in Service, Technical, and/or Quality Agreements.
This SOP provides guidance to evaluate the potential of the proposed new product for cross-contamination and assessment of the containment approach required to manufacture the new product at Manufacturing and Packaging Facilities
This procedure is to ensure that the manufacture of all finished drug products and Active Pharmaceutical Ingredients is accompanied by risk-based approaches and controls which are designed, implemented, maintained and monitored to manage the risk of Cross-Contamination, to a pre-defined, scientifically derived level of acceptability which meets current regulatory agency expectations and ensures patient safety and to prevent Mix-ups and…
Technology transfer: Technology transfer/product transfer is a complete documented process that covers the detailed documentation for manufacturing and dispatch of the product(s), received from the Transferring Unit (R&D of a new or existing product from a particular site) with manufacturing, packaging and analytical details