1.0 OBJECTIVE To laid down a procedure for raising file note. 2.0 SCOPE This procedure is applicable for the changes made having no GMP concern. 3.0 RESPONSIBILITY 3.1 Concerned department Heads to raise/initiate and Implement. 4.0 ACCOUNTABILITY 4.1 Executive Director, Quality 5.0 PRECAUTIONS 5.1 ...

1.0 OBJECTIVE To provide guidelines for the transfer of analytical methods for testing of raw materials and finished products to site laboratories where the routine testing shall be carried out including the training of the concerned chemist and proper documentation. 2.0 SCOPE This procedure is applicable ...

Objective To ensure that the area and equipment to be used for the dispensing, manufacturing and packing of products are free from remnants of previous product/batch. Scope This procedure is applicable for clearance of dispensing, manufacturing, packing area & equipments. Responsibility =>> IPQA ...

1.0 OBJECTIVE To provide a guideline for reprocessing. 2.0 SCOPE This procedure is applicable for reprocessing in tablet department at (Company Name). 3.0 RESPONSIBILITY 3.1 Production officer shall be responsible for recording the necessary details & to perform the activity as directed. 3.2 ...

Objective: To provide the guidelines for compilation of data for process parameters, assay values for actives to establish that Process performs according to design and is under control. Trend analysis data can be used to apply reduced testing in non-regulatory specifications after having established ...

Quality assurance is vital when checking whether your services, products and team procedures are in line with legal guidelines for your business. However, quality assurance is all about checking that you are consistently providing good service. Adhering to your own standards for customer experience is ...

The quality assurance process generally follows a standard ‘PDCA’ model, where a test environment includes the following steps: Plan The planning phase is where initial quality standards are developed and decisions are made. Whether you’re following a standardized framework or not, ...

Unlike quality control, quality assurance is usually focused on how processes are performed or how services are delivered. It focuses on preventing mistakes made by creating and evaluating processes, strategies and brand policies. Typically, your quality assurance function will have a “checklist” ...