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October 15, 2024
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Chemical SOP
Microbiology SOP
Warehouse SOP
Manufacturing SOP
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Post Views: 1,232 A Hormone is defined as a chemical released by a cell or a gland in one part of the body that sends out
Post Views: 1,830 HIRA (Hazard Identification and Risk Assessment) is a structured method for detecting and evaluating hazards in process facilities/systems. HIRA detects potential risks that
Post Views: 2,436 Preventive Maintenance is performed when the equipment is in working condition and satisfactorily produces a desired output within the capacity. Preventive Maintenance in
Post Views: 1,966 A User Requirement Specification (URS) is a formal document that outlines the needs of a user for a system, product, or service. In the
Post Views: 1,515 The URS is a definition of requirements to fulfil the demands of the process from the Users’ point of view. The success of
Post Views: 1,073 Oncology in the pharma industry is the development and manufacturing of cancer treatments. The term “Oncology” comes from the words “Onco” which means bulk,
Post Views: 1,709 A User Requirement Specification for DPI is a formal document that defines the requirements for using a system in a regulated environment, such
Post Views: 2,221 A User Requirement Specification Ointments is a document that defines the procurement requirements for equipment. It’s usually written early in the validation process,
Post Views: 1,756 A placebo is a “physiologically inert substance or sham intervention (psychological, physical or mechanical) which produces beneficial effects independent of any direct therapeutic effects”. The
Post Views: 2,569 In the pharmaceutical industry, Occupational Exposure Limit (OEL) refers to the maximum acceptable concentration of a hazardous substance in workplace air for
Post Views: 2,680 Lyophilizer Qualification in Pharma is an important aspect in pharma. Lyophilization, also known as freeze-drying, is a process used to preserve a
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Post Views: 3,670 Analytical method validation in Pharma is a critical process in the development and implementation of methods used for data analysis in various
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Post Views: 1,749 ACTIVITIES TEST FREQUENCY REFERENCE Instrument Calibration As per SOP Yearly (±30 days) As per SOP Type A Cleaning Visual Inspection Batch to
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Post Views: 10,443 Microbiology SOP in Pharma plays important role in pharmaceuticals. Microbiology is the study of microscopic living organisms, such as bacteria and fungi.
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Post Views: 3,014 A walk-in stability chamber is a controlled environment designed to simulate specific conditions such as temperature, humidity, and light to test the
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Post Views: 5,436 In general, large companies with multiple sites have one site that serves as “headquarters” for the corporation. It’s the place where (irrespective
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Post Views: 3,319 The User Requirements Specification describes the business needs for what users require from the system. User Requirements Specifications are written early in the
Post Views: 3,665 Stability testing is utilized to determine if the quality of a drug substance or drug product is altered over time by various environmental
Post Views: 4,086 A Critical Process Parameter (CPP) is a term used in pharmaceutical production for process variables which have an impact on a critical
Post Views: 2,875 Every activity in Pharma have some frequencies whether it is revision of documents, qualification, validation, stability, Re-testing etc. While Acceptance criteria means numerical
Post Views: 4,039 A “media fill” (sometimes known as a “process simulation”) is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium
Post Views: 2,591 Miscellaneous Documents in Pharma are those documents which does not comes under any dosage form and can be applied in general.
Post Views: 3,265 Pharmaceutical formulation is the process of combining various chemical substances with the active drug to form a final medicinal product, which is
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Post Views: 4,195 All criticalities emerged during the FAT exercise are then checked again at the final site, after installation and verification; additional test cases may
Post Views: 3,809 Microbiology Instruments Qualification plays important role in pharmaceuticals. Microbiology equipment is a large category covering all kinds of items used in microbiology
Post Views: 4,639 An “API Starting Material” is a raw material, intermediate, or an API that is used in the production of an API and
Post Views: 4,594 Dry powders for oral suspension are powder mixtures that require the addition of water (reconstitution) at the time of dispensing and are mostly
Post Views: 3,671 Pharmaceutical Aerosols are pressurized dosage forms containing one or more active ingredients which upon activation emit a fine dispersion of liquid and/or
Post Views: 4,050 In the world of Pharmaceuticals, a Factory Acceptance Test (FAT) is simply a series of test for a newly manufactured equipment. With a Factory
Post Views: 3,655 The User Requirement Specification for Microbiology (URS) is offered to help the user with the crucial facets of fabrication, facilities for installing
Post Views: 2 During Hold Time Study in Pharma, Good manufacturing practices (GMP) require that arrangements should be made to ensure that the dispensed raw
Post Views: 6,565 The pharmaceutical industry places a lot of importance on the temperature mapping study of cold chambers, incubators, warehouses, transport validation, stability chambers,
Post Views: 4,439 In the domain of microbiology, the process by which it is proven by laboratory tests that a method’s performance characteristics satisfy the
Post Views: 4,103 By evaluating the tests for weight variation, hardness, and friability, for example, IPQA Instruments in Pharma assess the test results from in-process
Post Views: 31,738 Nitrogen System Qualification plays important role in pharmaceuticals. PSA (Pressure Swing Adsorption) Based Nitrogen Plant is to produce Nitrogen gas from Atmospheric
Post Views: 6,446 Compressed air Qualification in pharma is proof that certain factors, including aerosol particle content, dew point, liquid water concentration, vapour content, oil
Post Views: 11,035 “Water” forms the most important ingredient in the pharmaceutical manufacturing process and also finds a major use in cleaning of equipment before
Post Views: 5,294 The User Requirements Specification (URS) is offered to help the user navigate the crucial aspects of fabrication, facility for installation of required
Post Views: 30,792 Manufacturing SOP in pharma, a component of the pharmaceutical business, is the process of synthesizing pharmaceutical medications on an industrial scale. A
Post Views: 21,291 Engineering SOP in Pharma is concentrated on planning, constructing, and enhancing pharmaceutical manufacturing facilities. Despite the fact that certain Pharma engineers also
