Post Views: 398 In the pharmaceutical industry, Occupational Exposure Limit (OEL) refers to the maximum acceptable concentration of a hazardous substance in workplace air for
Post Views: 682 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: 1,418 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: 895 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: 4,595 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: 2,967 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: 2,251 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: 2,333 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: 2,368 A Critical Process Parameter (CPP) is a term used in pharmaceutical production for process variables which have an impact on a critical
Post Views: 1,891 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: 2,092 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: 1,734 Miscellaneous Documents in Pharma are those documents which does not comes under any dosage form and can be applied in general.
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Post Views: 2,933 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: 2,581 Microbiology Instruments Qualification plays important role in pharmaceuticals. Microbiology equipment is a large category covering all kinds of items used in microbiology
Post Views: 3,145 An “API Starting Material” is a raw material, intermediate, or an API that is used in the production of an API and
Post Views: 3,132 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: 2,507 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: 2,653 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: 2,265 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: 4,419 The pharmaceutical industry places a lot of importance on the temperature mapping study of cold chambers, incubators, warehouses, transport validation, stability chambers,
Post Views: 2,540 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: 2,621 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: 16,235 Nitrogen System Qualification plays important role in pharmaceuticals. PSA (Pressure Swing Adsorption) Based Nitrogen Plant is to produce Nitrogen gas from Atmospheric
Post Views: 4,173 Compressed air Qualification in pharma is proof that certain factors, including aerosol particle content, dew point, liquid water concentration, vapour content, oil
Post Views: 6,268 “Water” forms the most important ingredient in the pharmaceutical manufacturing process and also finds a major use in cleaning of equipment before
Post Views: 2,583 The User Requirements Specification (URS) is offered to help the user navigate the crucial aspects of fabrication, facility for installation of required
Post Views: 16,499 Manufacturing SOP in pharma, a component of the pharmaceutical business, is the process of synthesizing pharmaceutical medications on an industrial scale. A
Post Views: 11,650 Engineering SOP in Pharma is concentrated on planning, constructing, and enhancing pharmaceutical manufacturing facilities. Despite the fact that certain Pharma engineers also
Post Views: 1,899 The ISO 9001 standard for Quality Management Systems first called for manuals in pharma as part of its requirements. Top-level publications that
Post Views: 3,099 The HR SOP in Pharma (HR department) of an organisation manages human resources and handles a variety of employment-related tasks, including hiring,
Post Views: 578 One of the most significant elements of the entire medication production process is quality assurance in pharma. It will not only enable
Post Views: 18,772 Cleaning Validation goal is to guarantee that cleaning procedures are effective in removing product residue, cleaning agent residue, and live microorganisms from
Post Views: 15,779 In the pharmaceutical sector, CSV is crucial for enhancing product quality, improving process performance, and supporting high-quality goods. The primary advantage of
Post Views: 1,162 Pharmaceuticals must include quality control SOP as a crucial component. The World Health Organization (WHO) defines quality control (QC) as the total
Post Views: 1,021 When raw materials (Active & Excipients) and packing materials are received and stored under the necessary storage conditions, this is known as
Post Views: 10,511 Information technology SOP in Pharma are used in the pharmaceutical industry to generate, process, store, retrieve, and communicate many types of data
Post Views: 2,096 Utility in Pharma like WFI, RODI, Compressed Air, Nitrogen, Air Handling Units (AHU) and HVAC (Heating, Ventilation and Air Conditioning) systems support
Post Views: 25,081 In the pharmaceutical industry, quality risk assessment in pharma entails the identification of hazards as well as the investigation and assessment of
Post Views: 3,859 Process validation, according to the FDA, is “…the gathering and evaluation of data, from the stage of process design to commercial production,
Post Views: 3,220 Every workplace has a specific set of hazards, and safety SOP in Pharma can help. The pharmaceutical manufacturing sector entails a variety
Post Views: 1,892 Large volume parenteral equipments qualifications in pharma play a significant role. Injectable aqueous medication products that have been terminally sterilized (autoclaved) and
Post Views: 2,136 Form Fill Seal Equipments qualifications in Pharma are crucial. To prepare sterile items, form fill seal (FFS) technology uses automated computer control.
Post Views: 1,926 Ampoule Equipments Qualification plays important role in pharma. An ampoule, also known as an ampul or an ampule, is a tiny sealed
Post Views: 1,529 Opthalmics Equipments Qualifications are crucial in the pharmaceutical industry. Opthalmics (Eye drops) are liquid drops that are often applied in small volumes,
Post Views: 2,332 Dry Powder Injections Equipments Qualifications in pharma play a significant part in dry powder injection equipment. Dry powder injections are solid materials
Post Views: 3,415 Oral liquids in Qualifications in Pharma are crucial. Pharmaceuticals include syrup, oral suspension, oral solution, oral drop, oral emulsion, mixture, linctus, and
Post Views: 2,616 Ointments qualifications in pharma plays a significant role. Ointments are cosmetic products that are applied externally to the skin. When applied to
Post Views: 1,803 Softgel Capsules Qualifications in Pharma plays important role in pharma. A Softgel Capsules have an exterior shell made of solid material that
Post Views: 2,965 Hardgel Capsules Qualifications plays important role in pharma. Hardgel Capsules are solid dose forms that contain one or more active ingredients and/or
Post Views: 3,929 Tablets Qualifications in Pharma plays important in pharma. Tablet is an oral solid dose form for medications (OSD). Tablets are a solid
