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What is eBMR and BMR as per PICS guideline? What is BMR? As per PICS guidelines, Batch production records should be prepared for each intermediate and API and should include complete information relating to the production and control of each…
` Quality Management System (QMS) as per ICH, WHO, and ISPE Guidelines Introduction to Quality Management System (QMS) A Quality Management System (QMS) is a comprehensive framework of policies, procedures, processes, and resources that ensures pharmaceutical companies consistently produce high-quality…
Look into HVAC in GMP as per WHO Introduction to HVAC Systems in Pharma GMP In pharmaceutical manufacturing, precision, quality, and compliance are paramount. Ensuring the integrity of medicinal products throughout their lifecycle requires meticulous attention to detail in every…
Introduction to Clean Rooms and Controlled Environments Clean rooms and controlled environments are specialized areas designed to maintain stringent levels of cleanliness, control various environmental parameters, and minimize contamination risks. They find applications across a wide range of industries such…
Differential Pressure: Differential pressure control involves maintaining specific pressure differentials between different areas within a pharmaceutical facility. It is used to control the flow of air and prevent cross-contamination between areas of varying cleanliness requirements. Positive pressure differentials are employed…
GMP Environmental control (Temperature, Humidity, Air Quality) as per guidelines Introduction of GMP Environmental control (Temperature, Humidity, Air Quality) Environmental control in pharmaceutical Good Manufacturing Practice (GMP) refers to the measures and practices implemented to maintain appropriate and controlled environmental…
Facility design and layout 1) Location and Surroundings 1.1) Preferred Location: The premises should ideally be situated in an industrial area and, under no circumstances, in residential or commercial zones. 1.2) Surrounding Environment: The premises should be located in an…
Introduction Compliance and enforcement play crucial roles in ensuring the implementation and adherence to Good Manufacturing Practices (GMP) within the manufacturing industry. GMP is a set of guidelines and regulations that govern the production, testing, and quality control of pharmaceuticals,…
1. Understanding Why GMP Compliance is Incumbent: To illustrate the importance of GMP compliance in Pharmaceuticals, let us consider a scenario involving a sterile area. Suppose there are several stages involved in producing a batch of medicine, such as sourcing…
Introduction Linseed, also known as flax or flaxseed, is a plant that belongs to the genus Linum and the family Linaceae. It is cultivated for its seeds, which are rich in oil and fiber, and for its stems, which are…
