Post Views: 3 Line clearance in the pharmaceutical industry is a critical process that ensures a production line is free from contaminants, previous product residues,
Post Views: 261 Regulatory affairs (RA) in pharma is a critical function that ensures pharmaceutical products meet legal and safety standards before they reach the
Post Views: 183 Supply chain management (SCM) in the pharmaceutical industry is a complex and highly regulated process that ensures the efficient flow of medicines
Post Views: 402 Pharmaceutical policies in a manufacturing plant focus on ensuring product quality, safety, compliance, and efficiency. These policies are governed by regulatory agencies
Post Views: 254 Self-inspection in the pharmaceutical industry is a critical aspect of Good Manufacturing Practices (GMP) compliance. It involves an internal audit conducted by
Post Views: 297 An Environment Monitoring System (EMS) in pharmaceuticals ensures that critical areas comply with the regulatory requirements for cleanliness, temperature, humidity, pressure, and
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Post Views: 286 A Project Validation Plan (PVP) for Quality Control (QC) facilities outlines the structured approach to ensure that the QC facilities comply with
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Post Views: 220 Pharmaceutical formulation and development involve transforming active pharmaceutical ingredients (API’s) into safe, effective, and patient-friendly medications. This process encompasses several key stages:
Post Views: 827 An Air Handling Unit (AHU) is a central component of HVAC (Heating, Ventilation, and Air Conditioning) systems. Its primary function is to
Post Views: 1,664 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: 2,743 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: 4,420 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: 2,456 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: 2,028 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: 1,501 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: 2,361 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: 2,854 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: 2,191 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: 3,990 In the pharmaceutical industry, Occupational Exposure Limit (OEL) refers to the maximum acceptable concentration of a hazardous substance in workplace air for
Post Views: 3,833 Lyophilizer Qualification in Pharma is an important aspect in pharma. Lyophilization, also known as freeze-drying, is a process used to preserve a
Post Views: 5,823 Analytical method validation in Pharma is a critical process in the development and implementation of methods used for data analysis in various
Post Views: 17,595 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: 3,974 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: 7,782 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: 3,934 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: 4,434 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: 5,622 A Critical Process Parameter (CPP) is a term used in pharmaceutical production for process variables which have an impact on a critical
Post Views: 3,351 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: 6,204 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: 3,193 Miscellaneous Documents in Pharma are those documents which does not comes under any dosage form and can be applied in general.
Post Views: 4,910 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: 5,239 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: 4,817 Microbiology Instruments Qualification plays important role in pharmaceuticals. Microbiology equipment is a large category covering all kinds of items used in microbiology
Post Views: 5,720 An “API Starting Material” is a raw material, intermediate, or an API that is used in the production of an API and
Post Views: 5,828 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: 4,234 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: 5,261 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: 4,604 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: 8,318 The pharmaceutical industry places a lot of importance on the temperature mapping study of cold chambers, incubators, warehouses, transport validation, stability chambers,
Post Views: 6,153 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: 5,375 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: 43,417 Nitrogen System Qualification plays important role in pharmaceuticals. PSA (Pressure Swing Adsorption) Based Nitrogen Plant is to produce Nitrogen gas from Atmospheric
Post Views: 8,789 Compressed air Qualification in pharma is proof that certain factors, including aerosol particle content, dew point, liquid water concentration, vapour content, oil
Post Views: 17,153 “Water” forms the most important ingredient in the pharmaceutical manufacturing process and also finds a major use in cleaning of equipment before
Post Views: 8,779 The User Requirements Specification (URS) is offered to help the user navigate the crucial aspects of fabrication, facility for installation of required
Post Views: 47,998 Manufacturing SOP in pharma, a component of the pharmaceutical business, is the process of synthesizing pharmaceutical medications on an industrial scale. A
Post Views: 29,746 Engineering SOP in Pharma is concentrated on planning, constructing, and enhancing pharmaceutical manufacturing facilities. Despite the fact that certain Pharma engineers also
Post Views: 3,895 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: 10,433 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: 2,258 One of the most significant elements of the entire medication production process is quality assurance in pharma. It will not only enable
Post Views: 55,077 Cleaning Validation goal is to guarantee that cleaning procedures are effective in removing product residue, cleaning agent residue, and live microorganisms from
Post Views: 45,238 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: 2,567 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: 25,870 Information technology SOP in Pharma are used in the pharmaceutical industry to generate, process, store, retrieve, and communicate many types of data
Post Views: 4,414 Utility in Pharma like WFI, RODI, Compressed Air, Nitrogen, Air Handling Units (AHU) and HVAC (Heating, Ventilation and Air Conditioning) systems support
Post Views: 78,033 In the pharmaceutical industry, quality risk assessment in pharma entails the identification of hazards as well as the investigation and assessment of
Post Views: 10,250 Process validation, according to the FDA, is “…the gathering and evaluation of data, from the stage of process design to commercial production,
Post Views: 8,290 Every workplace has a specific set of hazards, and safety SOP in Pharma can help. The pharmaceutical manufacturing sector entails a variety
Post Views: 3,892 Large volume parenteral equipments qualifications in pharma play a significant role. Injectable aqueous medication products that have been terminally sterilized (autoclaved) and
Post Views: 3,961 Form Fill Seal Equipments qualifications in Pharma are crucial. To prepare sterile items, form fill seal (FFS) technology uses automated computer control.
Post Views: 3,867 Ampoule Equipments Qualification plays important role in pharma. An ampoule, also known as an ampul or an ampule, is a tiny sealed
Post Views: 2,886 Opthalmics Equipments Qualifications are crucial in the pharmaceutical industry. Opthalmics (Eye drops) are liquid drops that are often applied in small volumes,
Post Views: 4,604 Dry Powder Injections Equipments Qualifications in pharma play a significant part in dry powder injection equipment. Dry powder injections are solid materials
Post Views: 6,617 Oral liquids in Qualifications in Pharma are crucial. Pharmaceuticals include syrup, oral suspension, oral solution, oral drop, oral emulsion, mixture, linctus, and
Post Views: 5,107 Ointments qualifications in pharma plays a significant role. Ointments are cosmetic products that are applied externally to the skin. When applied to
Post Views: 3,287 Softgel Capsules Qualifications in Pharma plays important role in pharma. A Softgel Capsules have an exterior shell made of solid material that
Post Views: 4,472 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: 7,617 Tablets Qualifications in Pharma plays important in pharma. Tablet is an oral solid dose form for medications (OSD). Tablets are a solid
