Post Views: 3 Introduction: Electricity is a critical utility in pharmaceutical manufacturing facilities, research laboratories, and quality control environments. It powers essential systems, including production
Post Views: 12 Introduction: Filter bags are critical components used in various manufacturing processes to remove particulate matter, ensure product purity, and maintain process sterility
Post Views: 6 Printed matter on hard gelatin capsules is the text, symbols, logos, or codes applied to the capsule shell. It can be: Why
Post Views: 24 Batch Release Before QC Release (sometimes called conditional, provisional, or preliminary release) is the process of approving a batch for distribution before
Post Views: 17 Pharmaceutical companies often purchase ready-to-file dossiers (including formulation, analytical, stability, and bioequivalence data) to accelerate product launches and reduce R&D costs. While
Post Views: 8 Pharmaceutical guidelines are structured recommendations and requirements established to ensure that medicinal products are consistently produced, controlled, and distributed to the highest
Post Views: 7 This risk assessment addresses the occurrence of intermixing of flavours during the manufacturing process of [Product Name]—specifically, the unintended combination of [Flavour
Post Views: 52 Introduction: In the pharmaceutical industry, maintaining the integrity of technical processes, regulatory compliance, and product quality is essential to safeguard patient safety
Post Views: 30 Cross Contamination in microbiology refers to the unintentional transfer of microorganisms from one material, sample, culture, environment, or person to another. This
Post Views: 28 Intermixing of blister strips refers to the unintended presence of blister packs containing tablets or capsules of a different product, strength, or
Post Views: 27 1️⃣ Why Foreign Fibres are Critical References: 2️⃣ Potential Origins of Fibres in Sterile Production In theory, fibres can come from multiple
Post Views: 19 The presence of White precipitates in parenteral vials is a critical deviation from the expected appearance of the drug product. Such precipitates
Post Views: 37 The presence of black particles in ampoules is a serious quality issue in parenteral manufacturing. These particles can originate from various sources
Post Views: 28 Risk Assessment for Not Hiring IT Personnel in pharmaceutical industry for ensuring compliance, data integrity, operational efficiency, and patient safety. This risk
Post Views: 19 This document presents a Risk Assessment for Employees Not Following Hierarchy in a small pharmaceutical company.In smaller organizations, clear reporting lines and
Post Views: 15 Risk Assessment for Workers Consuming Narcotics during Duty Time Consumption of narcotics or other psychoactive substances by employees during working hours presents
Post Views: 11 Risk Assessment for Narcotic Drugs Consumption Not Updated as per the Regulatory requirements, accurate and timely recording of narcotic drug consumption is
Post Views: 24 Risk Assessment on Management Not Taking Audits Seriously and Focusing Solely on Productivity: Audits—whether internal, external, regulatory, or customer-driven—are essential mechanisms for
Post Views: 33 Risk Assessment of QMS Not Effective, an effective Quality Management System (QMS) forms the foundation of consistent product quality, regulatory compliance, and
Post Views: 25 In pharmaceutical manufacturing, the calculation of Active Pharmaceutical Ingredient (API) quantities plays a critical role in ensuring that each batch meets the
Post Views: 19 1️⃣ Hazard Description Visual inspection is a critical step for detecting: Failure to perform visual inspection can result in defective or non-compliant
Post Views: 32 Technology transfer is the formal process by which product and process knowledge developed during research and development is transferred to commercial manufacturing.
Post Views: 17 1. Identify the Critical Quality Attributes First, you must define what characteristics are critical for the product. Examples: 2. Stability Studies Shelf
Post Views: 13 Enterprise Resource Planning (ERP) is an integrated software solution that enables organizations to manage and automate core business processes within a unified
Post Views: 21 1. What is Media Fill? Media fill (Process Simulation): Regulatory Expectation: Frequency: 2. Hazard Identification Hazard: Failure to perform or complete required
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Post Views: 40 Introduction: The Acceptable Quality Level (AQL) inspection is a critical component of the quality assurance process that determines whether a batch of
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Post Views: 5 Introduction: Media fill is a simulation of the actual aseptic manufacturing process, where instead of the drug product, a nutrient-rich microbiological growth
Post Views: 5 Risk Assessment for Cleaning Validation
Post Views: 333 Checklist for Cleaning Validation
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Post Views: 530 A Risk Assessment for QC instruments in the pharmaceutical industry is critical to ensure accurate, reliable, and compliant data. The purpose of
Post Views: 485 In the pharmaceutical industry, “deviation” refers to any departure from approved processes, procedures, specifications, or expected outcomes. These deviations can occur during
Post Views: 714 Change Control in the pharmaceutical industry is a critical part of Quality Management System (QMS). It ensures that all changes to a
Post Views: 414 Pharmaceutical Artwork refers to the design and layout of packaging, labels, and informational leaflets for medicines. It plays a crucial role in
Post Views: 1,034 Line clearance in the pharmaceutical industry is a critical process that ensures a production line is free from contaminants, previous product residues,
Post Views: 762 Regulatory affairs (RA) in pharma is a critical function that ensures pharmaceutical products meet legal and safety standards before they reach the
Post Views: 483 Supply chain management (SCM) in the pharmaceutical industry is a complex and highly regulated process that ensures the efficient flow of medicines
Post Views: 1,088 Pharmaceutical policies in a manufacturing plant focus on ensuring product quality, safety, compliance, and efficiency. These policies are governed by regulatory agencies
Post Views: 988 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: 819 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: 586 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: 532 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: 2,310 An Air Handling Unit (AHU) is a central component of HVAC (Heating, Ventilation, and Air Conditioning) systems. Its primary function is to
Post Views: 1,784 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: 3,120 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: 5,254 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: 2,567 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: 2,212 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: 1,612 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: 2,532 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: 2,955 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: 2,317 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: 4,428 In the pharmaceutical industry, Occupational Exposure Limit (OEL) refers to the maximum acceptable concentration of a hazardous substance in workplace air for
Post Views: 4,469 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: 7,488 Analytical method validation in Pharma is a critical process in the development and implementation of methods used for data analysis in various
Post Views: 2,894 🚨 PRODUCT RECALL IN PHARMA A product recall is a critical GMP process used to remove a defective, potentially harmful, or non-compliant
Post Views: 23,122 Microbiology SOP in Pharma plays important role in pharmaceuticals. Microbiology is the study of microscopic living organisms, such as bacteria and fungi.
Post Views: 8,204 🏭 FACILITY QUALIFICATION IN PHARMA Facility qualification is a systematic process of verifying and documenting that the design, construction, and operation of
Post Views: 3,866 📦 Packing Materials in Pharmaceuticals 🎯 Purpose Packing materials protect drug products from: They also: 🧭 Classification of Packing Materials 1️⃣ Primary
Post Views: 3,689 Transport validation is a Good Distribution Practice (GDP) requirement. It ensures that pharmaceutical products are consistently transported under conditions that maintain their
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Post Views: 4,333 A walk-in stability chamber is a controlled environment designed to simulate specific conditions such as temperature, humidity, and light to test the
Post Views: 3,045 Microbiology data evaluation involves systematically reviewing, trending, and interpreting data generated from environmental monitoring, product testing, and utilities monitoring to ensure compliance
Post Views: 2,874 🧭 Criticality Evaluation of Instruments in Pharma ✅ What is Criticality Evaluation? Criticality evaluation is the process of assessing instruments to determine
Post Views: 2,786 ✅ What is a BMS? A Building Management System (BMS) is an integrated control system that monitors, controls, and records critical facility
Post Views: 5,067 ✅ What is ERP Validation? ERP (Enterprise Resource Planning) Validation means providing documented evidence that the ERP system: 🎯 Why is ERP
Post Views: 8,369 In general, large companies with multiple sites have one site that serves as “headquarters” for the corporation. It’s the place where (irrespective
Post Views: 3,307 QC (Quality Control) chemical testing ensures raw materials, intermediates, and finished products meet defined specifications. Adherence to Good Testing Procedures is essential
Post Views: 4,680 Job Descriptions in the pharmaceutical industry vary greatly depending on the role, but I’ll give you a clear template you can adapt
Post Views: 4,297 QC (Quality Control) chemical testing ensures raw materials, intermediates, and finished products meet defined specifications. Adherence to Good Testing Procedures is essential
Post Views: 4,677 🧪 Qualification of IPQC Instruments in Pharma ✅ What are IPQC Instruments? IPQC (In-Process Quality Control) instruments are devices used during manufacturing
Post Views: 3,091 Good Testing Procedure (GTP) for Microbiology – Introduction Microbiological testing ensures products, materials, and environments comply with quality, safety, and regulatory standards.
Post Views: 4,057 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: 4,679 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: 6,036 A Critical Process Parameter (CPP) is a term used in pharmaceutical production for process variables which have an impact on a critical
Post Views: 3,430 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: 6,880 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: 3,377 Miscellaneous Documents in Pharma are those documents which does not comes under any dosage form and can be applied in general.
Post Views: 7,398 Pharmaceutical formulation is the process of combining various chemical substances with the active drug to form a final medicinal product, which is
Post Views: 5,442 Introduction: This User Requirement Specification (URS) defines the requirements for the selection, procurement, installation, qualification, and use of chemical instruments intended for
Post Views: 5,459 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: 5,258 Microbiology Instruments Qualification plays important role in pharmaceuticals. Microbiology equipment is a large category covering all kinds of items used in microbiology
Post Views: 6,110 An “API Starting Material” is a raw material, intermediate, or an API that is used in the production of an API and
Post Views: 6,060 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: 4,282 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: 5,620 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: 5,185 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: 8,923 The pharmaceutical industry places a lot of importance on the temperature mapping study of cold chambers, incubators, warehouses, transport validation, stability chambers,
Post Views: 7,119 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: 5,688 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: 44,629 Nitrogen System Qualification plays important role in pharmaceuticals. PSA (Pressure Swing Adsorption) Based Nitrogen Plant is to produce Nitrogen gas from Atmospheric
Post Views: 10,128 Compressed air Qualification in pharma is proof that certain factors, including aerosol particle content, dew point, liquid water concentration, vapour content, oil
Post Views: 20,454 “Water” forms the most important ingredient in the pharmaceutical manufacturing process and also finds a major use in cleaning of equipment before
Post Views: 10,917 The User Requirements Specification (URS) is offered to help the user navigate the crucial aspects of fabrication, facility for installation of required
Post Views: 57,347 Manufacturing SOP in pharma, a component of the pharmaceutical business, is the process of synthesizing pharmaceutical medications on an industrial scale. A
Post Views: 32,594 Engineering SOP in Pharma is concentrated on planning, constructing, and enhancing pharmaceutical manufacturing facilities. Despite the fact that certain Pharma engineers also
Post Views: 4,350 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: 13,108 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: 7,775 One of the most significant elements of the entire medication production process is quality assurance in pharma. It will not only enable
Post Views: 61,324 Cleaning Validation goal is to guarantee that cleaning procedures are effective in removing product residue, cleaning agent residue, and live microorganisms from
Post Views: 48,588 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: 8,112 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: 26,868 Information technology SOP in Pharma are used in the pharmaceutical industry to generate, process, store, retrieve, and communicate many types of data
Post Views: 4,806 Utility in Pharma like WFI, RODI, Compressed Air, Nitrogen, Air Handling Units (AHU) and HVAC (Heating, Ventilation and Air Conditioning) systems support
Post Views: 91,321 In the pharmaceutical industry, quality risk assessment in pharma entails the identification of hazards as well as the investigation and assessment of
Post Views: 12,420 Process validation, according to the FDA, is “…the gathering and evaluation of data, from the stage of process design to commercial production,
Post Views: 9,536 Every workplace has a specific set of hazards, and safety SOP in Pharma can help. The pharmaceutical manufacturing sector entails a variety
Post Views: 4,072 Large volume parenteral equipments qualifications in pharma play a significant role. Injectable aqueous medication products that have been terminally sterilized (autoclaved) and
Post Views: 4,192 Form Fill Seal Equipments qualifications in Pharma are crucial. To prepare sterile items, form fill seal (FFS) technology uses automated computer control.
Post Views: 4,088 Ampoule Equipments Qualification plays important role in pharma. An ampoule, also known as an ampul or an ampule, is a tiny sealed
Post Views: 2,998 Opthalmics Equipments Qualifications are crucial in the pharmaceutical industry. Opthalmics (Eye drops) are liquid drops that are often applied in small volumes,
Post Views: 4,984 Dry Powder Injections Equipments Qualifications in pharma play a significant part in dry powder injection equipment. Dry powder injections are solid materials
Post Views: 7,217 Oral liquids in Qualifications in Pharma are crucial. Pharmaceuticals include syrup, oral suspension, oral solution, oral drop, oral emulsion, mixture, linctus, and
Post Views: 5,552 Ointments qualifications in pharma plays a significant role. Ointments are cosmetic products that are applied externally to the skin. When applied to
Post Views: 3,441 Softgel Capsules Qualifications in Pharma plays important role in pharma. A Softgel Capsules have an exterior shell made of solid material that
Post Views: 4,691 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: 8,845 Tablets Qualifications in Pharma plays important in pharma. Tablet is an oral solid dose form for medications (OSD). Tablets are a solid
