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Chemical SOP
Microbiology SOP
Warehouse SOP
Manufacturing SOP
Information technology SOP
Post Views: 123,490
Hormones in Pharma
Documents

HORMONES IN PHARMA

Post Views: 1,358 A Hormone is defined as a chemical released by a cell or a gland in one part of the body that sends out

HAZARD IDENTIFICATION AND RISK ASSESSMENT
Safety

HAZARD IDENTIFICATION AND RISK ASSESSMENT (HIRA)

Post Views: 2,032 HIRA (Hazard Identification and Risk Assessment) is a structured method for detecting and evaluating hazards in process facilities/systems. HIRA detects potential risks that

Engineering

PREVENTIVE MAINTENANCE IN PHARMA

Post Views: 2,756 Preventive Maintenance is performed when the equipment is in working condition and satisfactorily produces a desired output within the capacity. Preventive Maintenance in

Documents

USER REQUIREMENT SPECIFICATION FOR OPHTHALMIC

Post Views: 2,093 A User Requirement Specification (URS) is a formal document that outlines the needs of a user for a system, product, or service. In the

User Requirement Specification for Ampoules
Documents

USER REQUIREMENT SPECIFICATION FOR AMPOULES

Post Views: 1,660 The URS is a definition of requirements to fulfil the demands of the process from the Users’ point of view. The success of

Oncology in Pharma
Documents

ONCOLOGY IN PHARMA

Post Views: 1,173 Oncology in the pharma industry is the development and manufacturing of cancer treatments. The term “Oncology” comes from the words “Onco” which means bulk,

User Powder Injection for Dry Powder Injection
User Requirement Specification

USER REQUIREMENT SPECIFICATION FOR DPI

Post Views: 1,883 A User Requirement Specification for DPI is a formal document that defines the requirements for using a system in a regulated environment, such

URS FOR OINTMENTS
Documents

USER REQUIREMENT SPECIFICATION FOR OINTMENTS

Post Views: 2,413 A User Requirement Specification Ointments is a document that defines the procurement requirements for equipment. It’s usually written early in the validation process,

Documents

PLACEBO

Post Views: 1,913 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

Qualification

OCCUPATIONAL EXPOSURE LEVEL (OEL) IN PHARMA

Post Views: 2,960 In the pharmaceutical industry, Occupational Exposure Limit (OEL) refers to the maximum acceptable concentration of a hazardous substance in workplace air for

Lyophilizer Qualification in Pharma
Qualification

LYOPHILIZER QUALIFICATION IN PHARMA

Post Views: 2,992 Lyophilizer Qualification in Pharma is an important aspect in pharma. Lyophilization, also known as freeze-drying, is a process used to preserve a

Analytical Method Validation
Documents

ANALYTICAL METHOD VALIDATION IN PHARMA

Post Views: 4,068 Analytical method validation in Pharma is a critical process in the development and implementation of methods used for data analysis in various

Articles

ACTIVITIES & THEIR FREQUENCIES

Post Views: 1,901 ACTIVITIES TEST FREQUENCY REFERENCE Instrument Calibration As per SOP Yearly (±30 days) As per SOP Type A Cleaning Visual Inspection Batch to

Documents

MICROBIOLOGY SOP IN PHARMA

Post Views: 11,505 Microbiology SOP in Pharma plays important role in pharmaceuticals. Microbiology is the study of microscopic living organisms, such as bacteria and fungi.

Documents

PHARMA BOOKS

Post Views: 3,211

Stability Chamber
Documents

STABILITY CHAMBER IN PHARMA

Post Views: 3,268 A walk-in stability chamber is a controlled environment designed to simulate specific conditions such as temperature, humidity, and light to test the

CQA
Documents

CORPORATE QUALITY ASSURANCE (CQA) SOP IN PHARMA

Post Views: 6,021 In general, large companies with multiple sites have one site that serves as “headquarters” for the corporation. It’s the place where (irrespective

Documents

USER REQUIREMENT SPECIFICATION FOR INJECTABLE

Post Views: 3,478 The User Requirements Specification describes the business needs for what users require from the system. User Requirements Specifications are written early in the

Documents

STABILITY IN PHARMA

Post Views: 3,879 Stability testing is utilized to determine if the quality of a drug substance or drug product is altered over time by various environmental

Documents

MEDIA FILL IN PHARMA

Post Views: 4,452 A “media fill” (sometimes known as a “process simulation”) is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium

Miscellaneous Documents
Documents

MISCELLANEOUS DOCUMENTS IN PHARMA

Post Views: 2,726 Miscellaneous Documents in Pharma are those documents which does not comes under any dosage form and can be applied in general.

Manufacturing in Pharma
Documents

BATCH MANUFACTURING & PACKING RECORDS

Post Views: 3,458 Pharmaceutical formulation is the process of combining various chemical substances with the active drug to form a final medicinal product, which is

Site Acceptance Test (SAT)
Qualification

SITE ACCEPTANCE TEST (SAT)

Post Views: 4,441 All criticalities emerged during the FAT exercise are then checked again at the final site, after installation and verification; additional test cases may

Microbiology Instruments Qualification
Microbiological Validations and Qualifications

MICROBIOLOGY INSTRUMENTS QUALIFICATION

Post Views: 4,045 Microbiology Instruments Qualification plays important role in pharmaceuticals. Microbiology equipment is a large category covering all kinds of items used in microbiology

API Qualifications
Qualification

API QUALIFICATIONS IN PHARMA

Post Views: 4,916 An “API Starting Material” is a raw material, intermediate, or an API that is used in the production of an API and

Qualification

AEROSOLS QUALIFICATIONS IN PHARMA

Post Views: 3,862 Pharmaceutical Aerosols are pressurized dosage forms containing one or more active ingredients which upon activation emit a fine dispersion of liquid and/or

Factory Acceptance Test
Qualification

FACTORY ACCEPTANCE TEST (FAT)

Post Views: 4,388 In the world of Pharmaceuticals, a Factory Acceptance Test (FAT) is simply a series of test for a newly manufactured equipment. With a Factory

URS for Microbiology

USER REQUIREMENT SPECIFICATION FOR MICROBIOLOGY

Post Views: 3,890 The User Requirement Specification for Microbiology (URS) is offered to help the user with the crucial facets of fabrication, facilities for installing

Hold Time Study in Pharma
Documents

HOLD TIME STUDY IN PHARMA

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

Microbiological Validations and Qualifications
Microbiological Validations and Qualifications

MICROBIOLOGICAL VALIDATIONS AND QUALIFICATIONS

Post Views: 4,823 In the domain of microbiology, the process by which it is proven by laboratory tests that a method’s performance characteristics satisfy the

IPQA instruments in Pharma
IPQA

SOP FOR IPQA INSTRUMENTS IN PHARMA

Post Views: 4,477 By evaluating the tests for weight variation, hardness, and friability, for example, IPQA Instruments in Pharma assess the test results from in-process

Nitrogen System Generation and Distribution Qualification
Nitrogen Qualification

NITROGEN SYSTEM QUALIFICATION

Post Views: 34,886 Nitrogen System Qualification plays important role in pharmaceuticals. PSA (Pressure Swing Adsorption) Based Nitrogen Plant is to produce Nitrogen gas from Atmospheric

Compressed Air System Qualification in Pharma
Compressed Air

COMPRESSED AIR QUALIFICATION IN PHARMA

Post Views: 6,938 Compressed air Qualification in pharma is proof that certain factors, including aerosol particle content, dew point, liquid water concentration, vapour content, oil

Water System Qualification in Pharma
Water System Qualification in Pharma

WATER SYSTEM QUALIFICATION IN PHARMA

Post Views: 12,154 “Water” forms the most important ingredient in the pharmaceutical manufacturing process and also finds a major use in cleaning of equipment before

User Requirement Specification
User Requirement Specification

USER REQUIREMENTS SPECIFICATION IN PHARMA

Post Views: 5,884 The User Requirements Specification (URS) is offered to help the user navigate the crucial aspects of fabrication, facility for installation of required

Engineering SOP in Pharma | Water System Validation | Compressed Air | Nitrogen | Pure Steame
Engineering

ENGINEERING SOP IN PHARMA

Post Views: 23,300 Engineering SOP in Pharma is concentrated on planning, constructing, and enhancing pharmaceutical manufacturing facilities. Despite the fact that certain Pharma engineers also

Manuals
Manuals

MANUALS IN PHARMA

Post Views: 3,156 The ISO 9001 standard for Quality Management Systems first called for manuals in pharma as part of its requirements. Top-level publications that

Human Resource
Human Resource (HR)

HR SOP IN PHARMA

Post Views: 7,026 The HR SOP in Pharma (HR department) of an organisation manages human resources and handles a variety of employment-related tasks, including hiring,

Quality Assurance
QUALITY ASSURANCE

QUALITY ASSURANCE IN PHARMA

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

Cleaning Validation
Cleaning Validation

CLEANING VALIDATION

Post Views: 41,433 Cleaning Validation goal is to guarantee that cleaning procedures are effective in removing product residue, cleaning agent residue, and live microorganisms from

computer system Validation
Software Validation

COMPUTER SYSTEM/PLC/SCADA VALIDATION

Post Views: 35,293 In the pharmaceutical sector, CSV is crucial for enhancing product quality, improving process performance, and supporting high-quality goods. The primary advantage of

Quality Control
Quality Control

QUALITY CONTROL SOP

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

Warehouse sop in pharma
WAREHOUSE

WAREHOUSE SOP IN PHARMA

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

Information Technology
Documents

INFORMATION TECHNOLOGY SOP IN PHARMA

Post Views: 20,597 Information technology SOP in Pharma are used in the pharmaceutical industry to generate, process, store, retrieve, and communicate many types of data

Utility
Utility

UTILITY IN PHARMA

Post Views: 3,647 Utility in Pharma like WFI, RODI, Compressed Air, Nitrogen, Air Handling Units (AHU) and HVAC (Heating, Ventilation and Air Conditioning) systems support

Quality Risk Assessment
Quality Risk Assessment

QUALITY RISK ASSESSMENT IN PHARMA

Post Views: 56,547 In the pharmaceutical industry, quality risk assessment in pharma entails the identification of hazards as well as the investigation and assessment of

Process Validation
Documents

PROCESS VALIDATION

Post Views: 7,404 Process validation, according to the FDA, is “…the gathering and evaluation of data, from the stage of process design to commercial production,

SAFETY
Safety

SAFETY SOP IN PHARMA

Post Views: 6,112 Every workplace has a specific set of hazards, and safety SOP in Pharma can help. The pharmaceutical manufacturing sector entails a variety

LVP
Large Volume Parenteral

LARGE VOLUME PARENTERAL EQUIPMENTS QUALIFICATIONS IN PHARMA

Post Views: 3,349 Large volume parenteral equipments qualifications in pharma play a significant role. Injectable aqueous medication products that have been terminally sterilized (autoclaved) and

Form Fill Seal
Form Fill Seal

FORM FILL SEAL EQUIPMENTS QUALIFICATIONS IN PHARMA

Post Views: 3,469 Form Fill Seal Equipments qualifications in Pharma are crucial. To prepare sterile items, form fill seal (FFS) technology uses automated computer control.

Ampoules
Ampoules

AMPOULE EQUIPMENTS QUALIFICATION

Post Views: 3,247 Ampoule Equipments Qualification plays important role in pharma. An ampoule, also known as an ampul or an ampule, is a tiny sealed

Opthalmics
Opthalmics

OPTHALMICS EQUIPMENTS QUALIFICATIONS

Post Views: 2,449 Opthalmics Equipments Qualifications are crucial in the pharmaceutical industry. Opthalmics (Eye drops) are liquid drops that are often applied in small volumes,

Oral Liquid
Documents

ORAL LIQUIDS QUALIFICATIONS IN PHARMA

Post Views: 5,637 Oral liquids in Qualifications in Pharma are crucial. Pharmaceuticals include syrup, oral suspension, oral solution, oral drop, oral emulsion, mixture, linctus, and

Ointment
Ointments

OINTMENTS QUALIFICATIONS IN PHARMA

Post Views: 4,342 Ointments qualifications in pharma plays a significant role. Ointments are cosmetic products that are applied externally to the skin. When applied to

Softgel Capsules
Documents

SOFTGEL CAPSULES QUALIFICATIONS IN PHARMA

Post Views: 2,894 Softgel Capsules Qualifications in Pharma plays important role in pharma. A Softgel Capsules have an exterior shell made of solid material that

Hardgel Capsules
Qualification

HARDGEL CAPSULES QUALIFICATIONS

Post Views: 4,067 Hardgel Capsules Qualifications plays important role in pharma. Hardgel Capsules are solid dose forms that contain one or more active ingredients and/or

Tablets
TABLETS

TABLETS QUALIFICATIONS IN PHARMA

Post Views: 6,363 Tablets Qualifications in Pharma plays important in pharma. Tablet is an oral solid dose form for medications (OSD). Tablets are a solid

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